Systems and methods for sensing and treating psychological and / or neurological disorders

Abstract

A system for treating an attention deficit disorder or for improving attention in a user. The system including a wearable device including a plurality of electrodes configured to be disposed over a region of a prefrontal cortex of a patient when the wearable device is worn by the patient a controller operatively coupled to the plurality of electrodes and configured to cause the plurality of electrodes to deliver a treatment session, the treatment session including delivery of transcranial random noise stimulation (tRNS) to the region of the prefrontal cortex with an current amplitude in a range of about 0.5 milliamps (mA) to about 2 mA for a period of time.

Description

SYSTEMS AND METHODS FOR SENSING AND TREATING PSYCHOLOGICAL AND / OR NEUROLOGICAL DISORDERSCross-reference to Related Applications

[0001] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 642,443, filed May 3, 2024, and entitled “Conformable Wearable Neural Devices and Operation Thereof,” U.S. Provisional Application No. 63 / 649,271, filed May 17, 2024, and entitled “Conformable Wearable Neural Devices and Operation Thereof,” and U.S. Provisional Application No. 63 / 748,858, filed January 23, 2025, and entitled “Systems and Methods for Sensing and Treating Psychological and Neurological Disorders,” the entire disclosure of which are hereby incorporated by reference herein.Technical Field

[0002] Embodiments described herein relate to a conformable neural device including a headset that includes sensors for detecting signals from a brain of a user, and systems and methods of treating neurological or psychological disorders and / or improving cognitive and / or executive function using same.Background

[0003] Current functional near-field infrared spectroscopy (fNIRS) devices may use a “swimming cap” style head cap to hold optical sensors and / or stimulators close and tight to the head of a user. These head caps cannot be self-administered reliably and often necessitate a research professional to position the head cap on the user. Furthermore, current fNIRS systems are typically only compatible with large and non-portable research equipment for data collection, processing, and / or storage. Therefore, current systems and devices may be impractical for an individual to use in a non-research environment (e.g., for therapeutic purposes).Summary

[0004] In some embodiments, a system includes a wearable device including a plurality of electrodes configured to be disposed over a region of a prefrontal cortex of a patient when the wearable device is worn by the patient; a controller operatively coupled to the plurality of electrodes and configured to: cause the plurality of electrodes to deliver a treatment session, thetreatment session including delivery of transcranial random noise stimulation (tRNS) to the region of the prefrontal cortex with a current amplitude in a range of about 0.5 milliamps (mA) to about 2 mA for a period of time.

[0005] In some embodiments, a method of treating attention-deficit / hyperactivity disorder (ADHD) includes delivering transcranial random noise stimulation (tRNS) to a region of a prefrontal cortex of the patient for a time period, the tRNS causing an effective electric field at the region of the prefrontal cortex in a range of about 0.1 Volts / meter (V / m) to about 0.30 V / m.

[0006] In some embodiments, a method includes delivering, via one or more electrodes, electrical stimulation causing a predetermined effective electrical field at one or more predetermined regions of a prefrontal cortex of a user while the user performs a task, wherein the electrical stimulation is delivered for at least about 15 minutes and up to about 60 minutes per day, at least once a day and between 4 days per week and 7 days per week, to treat an attention deficit disorder or to enhance attention of the user.

[0007] A headset configured to be worn on a forehead of a user, the headset comprising a first column including a first optical sensor, the first column configured to contact the forehead of the user; a second column including a second optical sensor, the second column configured to contact the forehead of the user; a flexible member coupling the first column to the second column, the flexible member configured to allow the first column and the second column to articulate relative to one another; and a controller operatively coupled to the first optical sensor and the second optical sensor, the controller configured to cause the first optical sensor to detect a first optical signal and the second optical sensor to detect a second optical signal, at least one of the first optical signal and the second optical signal associated with a brain activity of the user.Brief Description of the Drawings

[0008] FIG. 1 is a block diagram illustrating a system including a neural device headset, according to embodiments.

[0009] FIG. 2 is a block diagram of a neural device headset configured to detect optical signals from a brain of a user, according to embodiments.

[0010] FIG. 3 is a block diagram of a neural device headset including at least a pair of columns coupled by one or more flexible regions, according to embodiments.

[0011] FIG. 4 is a block diagram of a controller of a neural device headset, according to embodiments.|0012] FIG. 5 is a side view of a neural device headset configured to detect optical signals from a brain of a user, according to embodiments.

[0013] FIG. 6 is a rear perspective view of the neural device headset of FIG. 5 showing a plurality of optical detection assemblies, according to embodiments.

[0014] FIG. 7 is a front view of the neural device headset of FIGS. 5-6 showing flexible regions interposed between a plurality of columns, according to embodiments.

[0015] FIG. 8 is a close-up front view of the neural device headset of FIGS. 5-7, according to embodiments.

[0016] FIG. 9 depicts a controller and a securement member of the neural device headset of FIGS. 5-8, according to embodiments.

[0017] FIGS. 10-12 depict a neural device headset disposed on a forehead of three different users, according to embodiments.

[0018] FIG. 13 A is a rear perspective view of a neural device headset showing a plurality of columns including optical detection assemblies and electrodes; and FIG. 13B is a close-up view of a column including a plurality of light emitters and light detectors, according to embodiments.

[0019] FIG. 14 is a rear perspective view of the neural device headset of FIGS. 13A-13B showing a plurality of columns including optical detection assemblies and electrodes, according to embodiments.

[0020] FIG. 15 is a front view of the neural device headset of FIGS. 13A-14 showing flexible regions interposed between a plurality of columns, according to embodiments.

[0021] FIG. 16 is a flow chart of an example method of mapping anatomical regions of a brain of a user to an optical sensor of the neural device headset, according to embodiments.

[0022] FIG. 17 is a flow chart of an example method of providing electrical stimulation to a brain of a user to treat a neurological and / or psychological disorder, according to an embodiment.

[0023] FIG. 18 shows target brain regions for delivering electrical stimulation to treat an attention deficit disorder.

[0024] FIGS. 19A-19C are images of different views of a patient’s brain showing electric field resulting from electrical stimulation delivered at the frontal cortex.

[0025] FIGS. 20A-20B show results from a clinical study in which patients were administered electrical stimulation to treat an attention deficit disorder.

[0026] FIG. 21A is a plot of an example waveform of an electrical stimulation signal that can be used to treat a neurological or psychological disorder; and / or to improve cognitive / ex- ecutive function; FIG. 2 IB illustrate how different noise levels affect an existing signal, demonstrating the principal behind how noise levels can increase the systems sensitivity to a desired input (i.e., stochastic resonance). (Top left panel: no noise; top right panel: weak noise; bottom left panel: optimal or desired noise; and bottom right panel: high noise); FIG. 21C shows an indicative plot of signal-to-noise ratio (SNR) vs. noise intensity of the electrical stimulations characteristic of stochastic resonance.Detailed Description(0027] Embodiments described herein relate to a portable headset that provides non-inva- sive brain monitoring (e.g., fNIRS), and optionally brain stimulation. The main challenges for portable neural wearable devices are that the devices should be simple to setup, comfortable, fit many head sizes, and produce high quality signals. Current fNIRS devices use a “swimming cap” style head cap to hold the sensors and / or stimulators of the device; however, the sensors and / or stimulators may be difficult to properly position over desired brain locations. Typically, a research professional applies these head caps to a user, i.e., positions the head caps on the head of the user, as self-administration may be unreliable. Furthermore, current systems and methods use large, non-portable hardware to collect, analyze, and / or store sensor data and / or to generate stimulation. In the field of fNIRS, the quality and conformity of the head fit of the wearable device is closely linked to the quality of the brain recordings. Therefore, a headset that is conformable and produces contact across a large area of the sensors and / or stimulators are needed to improve the quality of monitoring and increase adoption by users.

[0028] When imaging the brain, light detectors measure light received back from a point, which indicates the brain activity at that point. However, without precise anatomical mapping of the position of such sensors to regions of the user’s brain, it can be difficult to match the channel data of the recorded brain activity with activation of a particular functional region of the brain. In the “swimming cap” neural devices, sensor probes are placed at specific positions using an electroencephalography (EEG) 10-20, EEG 10-10 or EEG 10-5 positional mapping.In such systems, the coordinates are defined radially, and different cap sizes may be used to ensure correct positioning across users of different head sizes and shapes. In contrast, systems and methods described herein achieve precise positioning of optical sensors on desired areas of the user’s brain without using EEG positional mapping. Instead, systems and methods described herein include flexible portions and use flex sensors and / or 3D mapping to enable a single headset to conform and / or map to users having various head shapes and sizes, thus allowing untrained users to the facilely use the headset while maintaining and improving accuracy.

[0029] Various embodiments of the headsets described herein may include a plurality of columns with a flexible region or flexible member interposed between each of the plurality of columns. The plurality of columns may include sensors and / or stimulators and may contact a forehead of the user when the user wears the headset. The flexible regions may allow the headset to conform to a horizontal and / or vertical curvature of the forehead of the user. The headset may be conformable such that the headset can accommodate a variety of different head sizes of users; however, each column of the plurality of columns may have a stiffness such that electronics to operate the device may be disposed therein and protected from mechanical damage (e.g., due to compression and / or rotational forces). Conformity of the headset is desirable because quality of brain stimulation and brain monitoring may depend on wide and consistent contact of the sensors and / or stimulators with the forehead of the user.

[0030] In some embodiments, headsets described herein may combine flexible and rigid regions to conform to the head of the user without sacrificing the density of the electronics present in the headset. The conformable neural device headset described herein may enable superior signal quality than other wearable devices which are less conforming. Fundamentally, the embodiments described herein enable dense brain imaging while also maintaining consistent physical contact of the sensors and / or stimulators with the forehead of users of many different shapes and sizes.10031] To address the challenge of anatomical mapping, the embodiments described herein map data to anatomical regions of the brain by detecting the curvature of the user’s forehead as they wear the conformable neural device. Using this information, better estimation of the position of the brain relative to the wearable device may be determined, allowing measured brain activity to be mapped to specific functional regions. In some embodiments, the headset may include one or more flex sensors configured to detect a degree of bending of at least aportion of the headset to map anatomical areas of the brain to a respective optical sensor and / or stimulator on the headset.

[0032] Various embodiments described herein also related to treatment methodologies and electrical energy doses that can be used to stimulate predetermined portions of a brain of a subject or patient to treat neurological and / or psychological disorders such as Attention-Defi- cit / Hyperactivity Disorder (ADHD). Specifically, some embodiments described herein relate to an electrical dose including a current having a predetermined amplitude to predetermined locations of a brain of the subject for a predetermined time period, and over a predetermined dosage period to treat ADHD or other psychological conditions. Such treatment methodologies can be delivered using the wearable devices described herein, or any other device.

[0033] Details related to systems, devices, and methods for monitoring brain activity using a wearable headset are described in PCT Application PCT / AU2022 / 050136, filed February 22, 2022, and entitled “Apparatuses, Systems, and Methods for Monitoring Symptoms of Neurological Conditions”, (hereinafter the “’ 136 application”) the disclosure of which is incorporated by reference herein in its entirety.

[0034] FIG. 1 is a block diagram illustrating a system 10 including a neural device headset 100 (hereinafter, “headset 100”), according to embodiments. The headset 100 may be operatively coupled to a controller 150 configured to control one or more operations of the headset 100. As shown, the headset 100 may be configured to communicate with a network 105 via the controller 150. The headset 100 can communicate with one or more compute devices 180, one or more databases 195, and / or one or more servers 190 via the network 105.

[0035] The network 105 may include one or more networks having one or more nodes that transmit, receive, forward, generate, buffer, store, route, switch, process, or a combination thereof one or more messages, packets, signals, or some combination thereof. The network 105 can include one or more networks that may be any type of network (e.g., a local area network (LAN), a wide area network (WAN), a virtual network, a telecommunications network, an internet, an intranet, a packet-switched network, a circuit- switched network, an ad hoc network, an infrastructure network, a public-switched telephone network, a cable network, a cellular network, a satellite network, a fiber optic network, etc.) implemented as a wired network and / or wireless network and used to operatively couple to any compute device, including compute device 180, server 190, database 195, and / or other device(s).

[0036] In some embodiments, the controller 150 can be configured to send data from the headset 100 (e.g., optical sensor data measured by optical sensors, flex data from flex sensors, etc.) to the compute device(s) 180, database(s) 195, and / or server(s) 190. In some embodiments, the controller 150 can include onboard processing (e.g., processor 452 as shown in FIG. 4) to process optical sensor data (e.g., filter, convert, etc.) prior to sending the optical sensor data to the compute device(s) 180, database(s) 195, and / or servers 190. In some embodiments, the controller 150 may send raw and / or partially processed sensor data to the compute device 180 via the network 105, and the compute device 180 may be configured to perform further processing and / or analyze at least a portion of the sensor data. In some embodiments, the controller 150 may be configured to receive a first signal (e.g., a light signal) indicative of brain blood oxygenation at a brain region of the user and / or a second signal (e.g., a light signal) indicative of scalp blood oxygenation of the user at the brain region, and the controller 150 may perform one or more operations to determine an activity data at the brain region. In some embodiments, the controller 150 may send the first signal, the second signal, and / or the activity data to the compute device(s) 180, the database(s) 195, and / or the server(s) 190 for storage. In some embodiments, the controller 150 may send or receive other relevant information including, but not limited to, anatomical mapping results, a model of the head of the user, and / or stimulation protocol information. In some embodiments, the controller 150 can include a communication interface (e.g., communication interface 454) that is configured to allow one-way or two-way communication with an external device, including, for example, the compute device^) 180, database(s) 195, and / or server(s) 190.

[0037] The compute device 180 can be any suitable compute device(s) such as, for example, a computer, a mobile phone or other portable device, such as, for example, a tablet, a laptop, a personal computer, a smart device, etc.

[0038] The server(s) 190 can include compute devices for running one or more processes and / or software for measuring and / or analyzing brain signals and / or determining a stimulation protocol for stimulating a region of the brain. Server(s) 190 can be in a location that is the same as or different from the headset 100, the controller 150, and / or the compute device 180. For example, the server 190 may include a physical server, a virtual server, or one or more physical or virtual servers.

[0039] The database(s) 195 can store information that can be accessible to server(s) 190, the compute device(s) 180, the controller 150 (and therefore the headset 100). In some embodiments, a database 195 can be a hard drive, a database, a cloud storage, a network-attachedstorage device, or other data storage device. In some embodiments, database(s) 195 can store sensor data collected by the optical sensors and / or flex sensors on the headset 100 and / or stimulation protocols for stimulating the brain (e.g., via electrodes disposed on the headset 100).

[0040] While not depicted in FIG. 1, it can be appreciated that the controller 150, the compute device(s) 180, the server(s) 190, and / or the database(s) 195 each can include components (e.g., a memory, a processor, a I / O device, etc.) that enable it to perform functions such as, for example, processing and / or analyzing the sensor data, or using the sensor data to determine information associated with brain activity of the user.[00411 FIG. 2 is a block diagram of a neural device headset (hereinafter, “headset 200”) configured to detect optical signals from a brain of a user, according to embodiments. In some embodiments, the headset 200 can be included in the system 10 of FIG. 1. As shown, the headset 200 includes a first column 210 including a first optical detection assembly 212 and a second column 220 including a second optical detection assembly 222. The first column 210 and the second column 220 may be configured to contact a forehead of the user such that the first optical detection assembly 212 is disposed on, near, or proximate to a first area of interest of the user’s brain, and the second optical detection assembly 222 is disposed on or near a second area of interest of the user’s brain. In some embodiments, the first area of interest and the second area of interest may be the same area and disposed between the first column 210 and the second column 220. The headset 200 may be structurally and / or functionally similar to the headset 100, and therefore certain details of the headset 200 are not described in further detail herein with respect to FIG. 2.

[0042] In some embodiments, the first area of interest and / or the second area of interest may include the user’s left and / or right lateral prefrontal cortex, the medial prefrontal cortex, and / or a boundary between the medial prefrontal cortex and the left and / or right lateral prefrontal cortex.

[0043] The optical detection assemblies 212, 222 may each include one or more light emitters and one or more light detectors. Each optical detection assembly 212, 222 may include any suitable number of light emitters such as, for example, 1 light emitter, 2 light emitters, 3 light emitters, 4 light emitters, 5 light emitters, 6 light emitters, 7 light emitters, 8 light emitters, 9 light emitters, or 10 light emitters, including any ranges or subranges therebetween. In some embodiments, each optical detection assembly 212, 222 may include any suitable number of light detectors such as, for example, 1 light detector, 2 light detectors, 3 light detectors, 4 lightdetectors, 5 light detectors, 6 light detectors, 7 light detectors, 8 light detectors, 9 light detectors, or 10 light detectors, inclusive of all ranges and subranges therebetween. In some embodiments, each optical detection assembly 212, 222 may include a first light emitter and two light detectors. In some embodiments, each optical detection assembly 212, 222 may include two light emitters and four light detectors. In some embodiments, a depth from which the optical detection assembly 212, 222 detects signals may be based on a distance between the light emitters) and the light detector(s). Therefore, the light emitter(s) and light detector(s) may be spaced at a distance corresponding to a depth of the brain and / or a depth of the scalp from the surface of the user’s head.

[0044] The first column 210 and the second column 220 may be coupled to one another by a flexible region 240 to allow the first column 210 and the second column 220 to articulate relative to one another. In some embodiments, the first column 210 and the second column 220 may be configured to bend relative to one another about a first axis to cause the headset 200 to conform to a horizontal curvature of a forehead of the user. In some embodiments, the first column 210 and the second column 220 may define a curvature along their respective lengths about a second axis orthogonal to the first axis such that the headset 200 accommodates a vertical curvature of the forehead of the user. In some embodiments, the headset 200 may be configured to conform to the horizontal and / or vertical curvature of the forehead such that first column 210 and the second column maintain substantial surface contact with the forehead of the user (e.g., at least 80% of a light sensitive inner surface of the column contacts the forehead of the user). In some embodiments, the first column 210 and the second column 220 may be at least partially rigid to protect electronics disposed on a surface of and / or in an inner volume thereof from mechanical damage (e.g., fatigue, damage due to compressive forces and / or rotational forces).

[0045] In some embodiments, the flexible region 240 may optionally include one or more flex sensor(s) 242 configured to generate an electrical signal indicative of a degree of bending of the flex sensor(s) 242. When the headset 200 is worn by the user, the flexible region 240 may bend about the first axis such that first column 210 and the second column 220 contact the forehead of the user and are disposed near a respective area of interest of the user’s brain. In some embodiments, the higher the flexure, bending, or curvature of the flexible region 240, the larger an electrical signal output by flex sensor 242. In this manner, a signal output by the flex sensor 242 may be correlated to the amount of bending of the flexible region 240 and thereby, a curvature of the user’s forehead or otherwise the user’s head.

[0046] In some embodiments, the flex sensor(s) may be any suitable sensor configured to output an electrical signal in response to curving, flexing, or bending including, but not limited to, a piezoelectric sensor, a piezoresistive sensor or flex sensing resistor (e.g., a Velostat sensor, conductive ink-based flex sensor), a capacitive sensor, a fiber optic flex sensor, or any suitable combination thereof. In some embodiments, the flexible region 240, the controller 250, and / or any portion of the headset 200 may further include one or more hardware components configured to collect and / or process the flex data. For example, the headset 200 may include amplifiers and / or converters configured to amplify the signal and / or convert change in resistance into voltage signals when applicable. The controller 250 may be configured to further analyze and / or process the amplified voltage signals to determine a bend profile of the headset 200, as described in further detail with respect to FIGS. 4 and 16. In some embodiments, the flex sensors) 242 may be electrically connected by flexible cables allowing the flex sensor(s) 242 to be dispersed throughout the headset 200 (e.g., on each flexible region 240).

[0047] In some embodiments, the headset 200 may further include a third column 230 interposed between the first column 210 and the second column 220. In such embodiments, the flexible region 240 may couple the first column 210 to the third column 230, and a second flexible region 240’ may couple the third column 230 to the second column 220. In some embodiments, the flexible regions 240, 240’ may allow the first column 210, the second column 220, and the third column 230 to articulate relative to one another. The first column 210, the second column 220, and the third column 230 may bend about a first axis to allow the columns 210, 220, 230 to accommodate the horizontal curvature of the forehead of the user. In some embodiments, the third column 230 may define a curvature along its length about a second axis orthogonal to the first axis to enable the headset 200 to accommodate the vertical curvature of the forehead of the user. In some embodiments, the third column 230 may include one or more electrodes 232 disposed on a surface thereof and configured to contact an area of interest of the user’s brain between the first column 210 and the second column 220. In some embodiments, the third column 230 may include any suitable number of electrodes or electrode contacts disposed thereon such as, for example, 1 electrode, 2 electrodes, 3 electrodes, 4 electrodes, 5 electrodes, 6 electrodes, 7 electrodes, 8 electrodes, 9 electrodes, 10 electrodes, 11 electrodes, 12 electrodes, 13 electrodes, 14 electrodes, 15 electrodes, 16 electrodes, 17 electrodes, 18 electrodes, 19 electrodes, or 20 electrodes, inclusive of all ranges and subranges therebetween. In some embodiments, the third column 230 may not include any electrodes.

[0048] The electrode(s) 232 may include any suitable conductive material including, but not limited to, a metal (e.g., platinum, stainless steel, titanium, copper, silver, nickel, gold, etc.) and / or a conductive polymer (e.g., polythiophene, polyaniline, polyindole, polypyrrole, poly [3,4-ethylenedioxythiophene], polyacetylene, polyphenylene vinylene (PPV), etc.). In some embodiments, the electrode(s) 232 may include a rubber-like conductive material.

[0049] The controller 250 may be operatively coupled to the optical detection assemblies 212, 222, the flex sensor(s) 242, 242’, and / or the electrode(s) 232. In some embodiments, a flexible region may couple the controller 250 to a column 210, 220, 230 such that the controller 250 can articular relative to one of the column 210, 220, 230. In some embodiments, the controller 250 may be configured to cause the electrode(s) 232 to stimulate the area of interest of the user’s brain. In some embodiments, the controller 250 may determine one or more stimulation parameters of the electrode(s) 232 based on the optical sensor data collected by the optical detection assemblies 212, 222. For example, the optical detection assemblies 212, 222 may measure signals indicative of brain activity at or near the area under the third column 230, and the controller 250 may process and / or analyze the measured signals and determine stimulation parameters based on the analysis. In some embodiments, the stimulation parameters may be predetermined.10050 [ In some embodiments, the headset 200 may include a plurality of columns, each pair of columns coupled by a respective flexible region. For example, the headset 200 may alternate between columns including optical detection assemblies 212, 222 and columns not including optical detection assemblies (e.g., columns including a surface without electronics and / or a surface including an electrode). In some embodiments, a total number of columns in the headset 200 may be in a range of about 2 columns to about 30 columns, inclusive of all ranges and subranges therebetween. In some embodiments, a total number of columns in the headset 200 may be in a range of about 2 columns, to about 16 columns, inclusive of all ranges and subranges therebetween. In some embodiments, the headset 200 may include an even number of columns. In some embodiments, the headset 200 may include an odd number of columns. In some embodiments, the total number of columns in the headset 200 may be 15 columns. In some embodiments, the total number of columns in the headset 200 may be 13 columns. In some embodiments, a number of columns including optical detection assemblies 212, 222 may be in a range of about 1 column to about 7 columns, inclusive of all ranges and subranges therebetween.

[0051] In some embodiments, a total number of light emitters in the headset 200 is in a range of about 1 light emitter to about 20 light emitters, inclusive of all ranges and subranges therebetween. In some embodiments, a total number of light emitters in the headset 200 is about 14 light emitters. In some embodiments, a total number of light detectors in the headset 200 is in a range of about 1 light detector to about 40 light detectors, inclusive of all ranges and subranges therebetween. In some embodiments, a total number of light detectors in headset 200 is about 28 light detectors.

[0052] In some embodiments, the plurality of columns 210, 220, 230, and the flexible regions 240, 240’ disposed therebetween may form a band configured to extend across and conform to a forehead of the user such that each column 210, 220, 230, is disposed over and / or adjacent to a respective area of interest of the brain. In some embodiments, the columns 210, 220, 230 may be arranged such that columns 210, 220 including optical detection assemblies 212, 222 may be disposed over and / or adjacent to predetermined areas of interest when the headset 200 is worn by the user. In some embodiments, a subset of columns 230 from the plurality of columns may not include sensors and / or stimulators. In some embodiments, the plurality of columns 210, 220, 230 may be vertically aligned. In some embodiments, a subset of columns 210, 220, 230 from the plurality of columns may be disposed at varying vertical positions relative to a horizontal centerline of the headset 200.

[0053] In some embodiments, a radius of curvature about the first axis (e.g., a horizontal radius of curvature) of the headset 200 may be greater than about 5 mm. In some embodiments, a radius of curvature about the second axis (e.g., a vertical radius of curvature) may be greater than about 80mm.

[0054] The headset 200 may be formed from any suitable material including metals, metal alloys, plastics, polymers, and or any suitable combination thereof. In some embodiments, the columns 210, 220, 230 and flexible regions 240, 240’ may include the same material. In some embodiments, the columns 210, 220, 230 may be formed from or include a different material than the flexible regions 240, 240’. In some embodiments, the columns may include a rigid material such as, for example, aluminum, steel, iron, thermoplastic polyurethane (TPU), high- density polyethylene (HDPE), polypropylene (PP), polycarbonate, Polyethylene terephthalate (PET), Polyvinyl Chloride (PVC), or a suitable combination thereof. In some embodiments, the columns 210, 220, 230 and / or the flexible regions 240, 240’ may include a flexible material such as, for example, Acrylonitrile butadiene styrene (ABS), rubber, butyl rubber, silicone, polytetrafluoroethylene, polypropylene, chlorobutyl rubber, low-density polyethylene (LDPE),or a suitable combination thereof. In some embodiments, the columns 210, 220, 230, and the flexible regions 240, 240’ may be formed from the same material (e.g., monolithically formed), but with the flexible regions 240, 240’ having a smaller thickness than the columns 210, 220, 230 causing the flexible regions 240, 240’ to have a substantially higher flexibility relative to the columns 210, 220, 230.

[0055] The headset 200 may further include a power source onboard the headset 200. The power source may be any suitable power source such as, for example, a rechargeable battery and / or a cord (e.g., USB cord) coupleable to a wall plug.|0056[ The headset 200 may further include a securement mechanism 270 including a se- curement member (e.g., a band, a belt, a clip, a rope, a slider, etc.) configured to be disposed around a back of the head of the user to secure at least the first column 210 and the second column 220 on the forehead of the user. In some embodiments, the headset 200 may include a first connector and a second connector configured to couple a first end and a second end of the securement mechanism 270, respectively to the one or more columns and / or the controller 250 of the headset 200. For example, the securement mechanism 270 may be configured to connect a first side (e.g., a left side) of the first column 210 and a first side (e.g., a right side) of the second column 220 such that the columns 210, 220, 230 and the securement mechanism 270 form a loop configured to be disposed around the head of the user. In some embodiments, the first end and / or the second end of the securement mechanism 270 may be configured to connect to a controller (e.g., the controller 150) and / or a power source of the headset 200. In some embodiments, the securement mechanism 270 may be configured to stretch such that the headset 200 may fit around different head sizes. For example, the securement mechanism 270 may include an elastic band. In some embodiments, a length of the securement mechanism 270 may be adjustable such that the headset 200 may fit around different head sizes. For example, the securement mechanism 270 may include an adjustment mechanism (e.g., Velcro, a belt buckle and pin, a ratchet and slider, etc.) such that the securement mechanism 270 can be attached to the first and / or second connectors with a varying length.

[0057] FIG. 3 is a block diagram of a headset 300 including at least a pair of columns 310, 320, 330 coupled by one or more flexible regions 340, 340’, according to embodiments. As shown, the headset 300 includes a first column 310 and a second column 320 with a flexible region 340 disposed therebetween. In some embodiments, the headset 300 may optionally include a third column 330 disposed between the first column 310 and the second column 320 such that the first flexible region 340 (or flexible member) couples the first column 310 to thethird column 330 and a second flexible region 340’ couples the third column 330 to the second column 320. For example, the flexible region 340 may be on a first side (e.g., a first lateral edge) of the third column 330, and the second flexible region 340’ may be on a second side opposite the first side (e.g., on a second lateral edge, on a back side, on an opposing surface, etc.) of the third column 330. The first side may be a left side of the third column 330 and the second side may be a right side of the third column 330 from the perspective of the user, or vice versa. The third column 330 may optionally include one or more electrode(s) 332 disposed thereon and configured to stimulate a region or portion of a brain of the user. The flexible regions 340, 340’ may optionally include one or more flex sensors 342. In some embodiments, the flexible region 340 may connect the first column 310 and the second column 320. In some embodiments, the headset 300 may be structurally and / or functionally similar to the headset 100, 200, and therefore certain details of the headset 300 are not described in further detail herein.

[0058] In some embodiments, the first column 310 includes a first light emitter 313, a first light detector 314a, and a second light detector 314b. The first light emitter 313 may be disposed on a first end (e.g., a top end) of the first column 310, and the first light detector 314a may be disposed a first distance DI from the first light emitter 313. The second light detector 314b may be disposed on a second end (e.g., a bottom end) of the first column 310 opposite the first end. Therefore, the second light detector 314b is disposed a second distance D2 from the first light emitter 313 larger than the first distance DI . The second column 320 may include a second light emitter 323, a third light detector 324a, and a fourth light detector 324b. As shown, the second light emitter 323 may be disposed on a first end (e.g., a bottom end) of the second column 320, and the third light detector 324a may be disposed a first distance DI from the second light emitter 323. The fourth light detector 324 may be disposed on a second end (e.g., a top end) of the second column 320 and at the second distance D2 from the second light emitter 323. While FIG. 3 shows the light emitters 313, 323 and the light detectors 314a, 314b, 324a, 324b in a particular configuration, it can be appreciated that the light emitters 313, 323 and the light detectors 314a, 314b, 324a, 324b may be arranged in any suitable configuration to detect light signals from a portion of the user’s head (e.g., see FIGS. 13-15).

[0059] As shown, each column 310, 320, 330 may have a length LI, and each flexible region 340, 340’ may have a length L2. In some embodiments, the length LI may be greater than the length L2. In some embodiments, the length LI may correspond to a vertical length of the forehead (e.g., between the eyebrows and a hairline of an average user). In someembodiments, the length LI may be in a range between about 30 mm to about 60 mm, inclusive of all ranges and subrange therebetween. In some embodiments, the columns 310, 320, 330 may have different lengths. In some embodiments, the length L2 may be in a range between about 10 mm to about 50 mm, inclusive of all ranges and subranges therebetween. In some embodiments, each column 310, 320, 330 may have a width Wl, and each flexible region 340, 340’ may have a width W2. In some embodiments, the width W 1 may be greater than the width W2. In some embodiments, the width Wl may be in a range between about 10 mm and about 20 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the width W2 may be in a range between about 2 mm and about 30 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the smaller magnitude of the width W2 may enable conformability of the headset 300, while also maintaining space for a high density of sensor(s) and / or support electronics. In some embodiments, the headset 300 may combine flexible and rigid regions to conform to the head of the user without sacrificing the density of the electronics present in the headset 300. In some embodiments, each of the columns 310, 320, 330 may have equal widths and / or lengths from one another. In some embodiments, any of the columns 310, 320, 330 may have different widths and / or lengths form one another. 0060] In some embodiments, the flexible regions 340, 340’ may have a thickness (e.g., a distance between a first surface configured to contact the forehead and a second surface opposite the first surface that faces away from the forehead) that is less than or equal to a corresponding thickness of the columns 310, 320, 330. In some embodiments, the thickness of the columns 310, 320, 330 may be in a range between about 5 mm and about 15 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the thickness of the flexible regions 340, 340’ may be in a range between about 3 mm and about 10 mm, inclusive of all ranges and subranges therebetween.

[0061] In some embodiments, the headset 300 may include a plurality of columns, each pair of columns from the plurality of columns coupled by a flexible region. In some embodiments, a total width of the plurality of columns together may be in a range between about 150 mm to about 400 mm, inclusive of all ranges and subranges therebetween.

[0062] FIG. 4 is a block diagram of a controller 450 of a neural device headset (hereinafter, “headset”), according to embodiments. In some embodiments, the controller 450 may include the controller 150 as described with respect to the system 10 and may be included in any of the headsets described herein (e.g., the headset 100, 200, 300, or any other headset described herein). As shown, the controller 450 may include a processor 452, a communication interface454, a memory 460, and may optionally include one or more input / output (I / O) devices 456. The controller 450 may execute one or more instructions or programs stored in a memory 460. The instructions, when executed by the processor, may cause the processor 452 to operate the headset (e.g., via the communication interface 454) to collect optical signals from the brain, map anatomical locations of the brain relative to the headset, and / or stimulate the brain via electrode(s). In some embodiments, the controller 450 may be structurally and / or functionally similar to the controllers 150, 250, and therefore certain details of the controller 450 are not described in further detail herein with respect to FIG. 4.

[0063] In some embodiments, the memory 460 may store one or more instructions that cause the processor 452 to control one or more components of the neural device headset (e.g., optical detection assemblies, flex sensors, and / or electrodes), to control the communication interface 454 to transmit information to and / or from the headset, and / or to control the I / O device^) 456. In some embodiments, the memory 460 may include instructions for anatomical mapping 462, activity determination 464, feature extraction 469, and my optionally include instructions for stimulation control 468 and / or progress / symptom severity determination 465. The controller 450 may be configured to receive one or more inputs including an optical detection signal and / or a flex resistor signal and transmit one or more outputs including an optical emission signal, an anatomical mapping signal, and / or an electrode stimulation signal. While the instructions in memory 460 are described as being on the controller 450, it can be appreciated that any or all of the instructions in memory 460 may be additionally and / or alternatively stored on an external device (e.g., compute device(s) 180, server(s) 190, and / or database(s) 195) and communicated to the controller 450 during processing. In some embodiments, one or more processing steps may occur on the external device.

[0064] The instructions for anatomical mapping 462 may cause the processor 452 to receive signals from one or more flex sensors disposed on the headset when the headset is worn by and conforms to a forehead of the user. In some embodiments, the signals from the one or more flex sensors may include an electrical signal (e.g., a resistance value and / or a voltage value) corresponding to a degree of curvature or bending of the flex sensor. For example, a magnitude of the electrical signal may be proportional to an amount of curvature of the flex sensor due to bending of the flexible region on which the flex sensor is disposed. In some embodiments, the instructions for anatomical mapping 462 may cause the processor 452 to determine a bending profile of the headset based on the signals from the one or more flex sensors. In some embodiments, the bending profile may include measurements representing adegree of bending at each flex sensor location. In some embodiments, the bending profile may include an average degree of bending across the entire headset based on measurements from each of the flex sensors. In some embodiments, the bending profile may include information corresponding to an orientation of each of the optical sensors (e.g., based on interpolation from the flex sensor data). In some embodiments, each flex sensor measurement may be compiled to create an interpolated bending distribution curve across the headset. The bending profile may correspond to a plot of curvature as a function of position along the headset. In some embodiments, the bending profile may define a radius of curvature across the entire headset. In some embodiments, the bending profile may be determined by interpolation and / or by using a pretrained model.

[0065] The instructions for anatomical mapping 462 may cause the processor to determine a curvature (e.g., a horizontal curvature and / or a vertical curvature) of the user’ s forehead based on the bending profile of the headset. In some embodiments, the curvature of the user’s forehead may be equivalent and / or proportional to the bending profile of the headset. In some embodiments, if the headset is in direct contact with the head of the user, the curvature of the user’s forehead may equivalent to the curvature (e.g., the bend profile) of the headset. In some embodiments, one or more adjustments to the bending profile of the headset may be completed to determine the curvature of the user’s forehead. The instructions for anatomical mapping 462 may cause the processor 452 to determine a position of a user’s brain relative to the headset based on the curvature of the user’s forehead. For example, the memory 460 may store relevant information such as common thicknesses of the skin, the skull, and / or the meninges, and the processor 452 may account for this information during processing. In some embodiments, the memory 460 may store common coordinates of brain locations relative to the skull.

[0066] In some embodiments, the instructions for anatomical mapping 462 may optionally include collecting image and / or video data of the headset disposed on the user’s head using an imaging device (e.g., an imaging device such as camera of an external device such as a mobile phone or smart device). For example, the controller 450 may be configured to receive an imaging device signal from the imaging device, which is indicative of the 3D model, and determine and / or generate a 3D model of the user’s head therefrom. In some embodiments, the external device or an external system may be used create the 3D model of the user’s head based on the image data and / or video data and transmit the created or determined 3D model to the controller 450 via the imaging device signal. In some embodiments, the image, video data, and / or the 3D model of the user’s head may be transmitted from the external device to thecontroller 450 (e.g., via network 105). In some embodiments, the 3D model of the user’s head may be used to determine the curvature of the user’s forehead. In some embodiments, an imaging device associated with a user device (e.g., a mobile phone or tablet) may be used to visually scan a user’s head, for example, capture a series of images or video of a user’s head. The series of images or video may then be used to generate the 3D model. In some embodiments, each of the 3D model and bending or curvature data obtained from the flex sensors may be used to determine the curvature or otherwise anatomical shape of the user’s head. Implementing a 3D head model may provide a more accurate assessment relative to using the 3D model or the flex sensor data alone.

[0067] Instructions for anatomical mapping 462 may include mapping each optical sensor disposed on the headset to a respective area of the user’s brain. For example, the memory 460 may store information related to a position of each optical sensor on the headset and information related to a position of one or more cortical areas based on known information of human anatomy. Therefore, the processor 452 may be configured to determine the cortical area from which each optical sensor is configured to receive signals. In some embodiments, the instructions for anatomical mapping 462 may include instructions for physics simulation modeling, or other machine learning or deep learning methods to map each channel of recorded brain activity to a specific area of activation in the user’s brain. Additionally, the data processing model that maps brain data to anatomical features may be supported using images or video recorded with the user’s phone. These images or video can be used to create the 3D models of the user’s head, providing another source of data for the mapping process. In some embodiments, the mapping of each optical sensor to an area of the user’s brain may be based at least on a position of the optical sensor on the headset, an orientation of the optical sensor relative to the brain of the user, the curvature of the head of the user, and / or a distance between a light emitter and a light detector of the optical sensor (e.g., for a depth coordinate). In some embodiments, the instructions for anatomical mapping 462 may be configured to be executed by the controller 450 and / or an external device without input from the user (e.g., automatically).

[0068] In some embodiments, the instructions for feature extraction 469 may cause the processor 452 to identify or extract characteristics or features of signals or data recorded by and received from the optical detection assemblies. The signals measured or calculated by the optical detection assemblies and / or the controller 450 may include changes in oxygenated hemoglobin (Hbo) and deoxygenated hemoglobin (Hbr), Hbo and Hbr curves, a combinations of the two, and / or total hemoglobin (ThB (ThB = Hbo + Hbr)). The features may be characteristic,or indicative of biomarkers associated with cognitive function or performance and / or cortical activity. In some embodiments, the feature extraction 469 operations may be deployed on a remote server, a local compute device, and / or the controller 450. In some embodiments, an activity measure may be determined based on one or more features extracted from the activity data. The activity measure may correspond to a level of neural activity at an area of the user’s brain.

[0069] In some embodiments, the feature(s) include or are indicative of functional connectivity between pairs of channels of the headset (i.e., the statistical dependence and / or similarity between pairs of data from neighboring or distinct regions of the brain). In some embodiments, the feature(s) comprise or are indicative of statistics applied to data derived from one or more channels (i.e., one or more optical sensors).

[0070] In some embodiments, the feature(s) may be used for activity determination 464. In some embodiments, the instructions of the memory 460 may include instructions for activity determination 464 to determine brain activity at an area of interest based on cerebral hemodynamic response(s) measured by the optical sensors. Instructions for activity determination 464 may include receiving a first signal (e.g., from a first light detector or first set of light detectors) indicative of a brain blood oxygenation of the user and receiving a second signal (e.g., from a second light detector or second set of light detectors) indicative of a scalp blood oxygenation of the user. The instructions for activity determination 464 may include subtracting the second signal from the first signal to determine an activity data corresponding to a brain region (e.g., the brain region mapped to the first and second light detectors via the anatomical mapping 462). In some embodiments, the instructions for activity determination 464 may include determining an activity data corresponding to the user’s left or right lateral prefrontal cortex, the medial prefrontal cortex, and / or a boundary between the medial prefrontal cortex and the left or right lateral prefrontal cortex.

[0071] In some embodiments, the features(s) may be used for progress / symptom severity determination. In some embodiments, the symptom severity measure may be indicative of a symptom of a neurological condition or a progress measure indicative of progress the user is making in treating symptoms of the neurological condition based on the measured brain activity (e.g., cerebral hemodynamic response). For example, for ADHD, the instructions for progress / symptom severity determination 465 may include determining an inattention score, a hyperactivity score, and / or an impulsivity score based on the sensor data. In some embodiments, the sensor data acquired from the left or right lateral prefrontal cortex, the medial prefrontalcortex, and / or a boundary between the medial prefrontal cortex and the left or right prefrontal cortex may be used to determine the inattention score, a hyperactivity score, and / or an impul- sivity score.

[0072] In some embodiments, the instructions for stimulation control 468 may cause the processor 452 to receive, as an input, the activity data and / or the activity measure, and to provide as an output, stimulation parameter value(s). The stimulation parameter(s) may be simply an on / off parameter value, or may include values for parameters such as frequency, duration, amplitude etc. Various examples of signal process, signal processing, data processing, and various anatomical and / or behavioral features that can extracted by the controller 450 based on signals received from the optical sensors are described in detail in the ‘ 136 application and therefore, not described in further detail herein.

[0073] In some embodiments, the instructions for stimulation control 468 may cause the processor 452 to generate an electrical stimulation signal that is configured to cause the electrodes (e.g., the electrodes 232) to deliver a predetermined dose of electrical energy to a predetermined locations of a brain of a user. For example, the instructions may cause a plurality of the electrodes 232 to deliver a treatment session (e.g., for treating ADHD) that includes delivery of transcranial random noise stimulation (tRNS) to a region of the prefrontal cortex of a subject with a current amplitude in a range of about 0.5 milliamps (mA) to about 1 mA, inclusive for a period of time, as described in further detail herein with respect to the method 90 shown in FIG. 17, so as to deliver an effective electric field of about 0.1 V / m to about 0.3 V / m at target regions of the prefrontal cortex. In some embodiments, the region of the prefrontal cortex may include a left lateral prefrontal cortex, a right lateral prefrontal cortex, a medial prefrontal cortex, a boundary region between the medial prefrontal cortex and the left lateral prefrontal cortex, or a boundary region between the medial prefrontal cortex and the right lateral prefrontal cortex. In some embodiments, the time period can in a range of about 15 minutes to about 30 minutes, inclusive.

[0074] As described herein, the term “effective electric field” refers to the actual electric field experienced by the region of the brain being stimulated after penetrating through the skin, skull, and cerebrospinal fluid (CSF) of the patient. The effective electric field may vary from subject as it may be dependent on the specific anatomy of the patient, for example, bone thickness, head shape, bone density, CSF volume, etc. The effective current density refers to the actual current density experienced by the region of the brain being stimulated. In some embodiments, the controller 450 may be configured to activate the electrodes 232 (or any otherelectrodes that may be included in any device at a current amplitude in a range of about 0.65 mA to about 0.85 mA, inclusive to cause delivery of tRNS with the effective electric field (e.g., in a range of about 0.1 V / m to about 0.3 V / m, inclusive) described herein. In some embodiments, a surface area of each of the plurality of electrodes (e.g., the electrodes 232) configured to deliver the effective electric field and / or effective current density based on the signal received from the controller 450 is in a range of about 6 cm2to about 12 cm2, inclusive. In some embodiments, the controller 450 may be configured to cause the plurality of electrodes to deliver the treatment session in a home setting. For example, a global positioning system (GPS) may be included in the controller 450 that may be configured to detect a location of the subject and deliver the treatment sessions described herein when the subject is at home. In other embodiments, a form factor, shape, and / or size of the neural headset or wearable device described herein is amenable for a subject to self-administrate a treatment session in a home or non- clinical setting. Treatment session and therapeutic doses that may be delivered via the controller 450, or any other controller described herein which can be included in any of the devices described herein, or any other devices that can be worn on at least a forehead of a user are described in further detail herein with respect to FIG. 17.

[0075] The processor 452 can be any suitable processing device(s) configured to run and / or execute a set of instructions or code (e.g., from the memory 460). For example, the processor 452 can be and / or can include one or more data processors, image processors, graphics processing units (GPU), physics processing units, digital signal processors (DSP), analog signal processors, mixed-signal processors, machine learning processors, deep learning processors, finite state machines (FSM), compression processors (e.g., data compression to reduce data rate and / or memory requirements), encryption processors (e.g., for secure wireless data and / or power transfer), and / or the like. The processor 452 can be, for example, a general-purpose processor, central processing unit (CPU), microprocessor, microcontroller, Field Programmable Gate Array (FPGA), an Application Specific Integrated Circuit (ASIC), a processor board, a virtual processor, and / or the like. The processor 452 can be configured to run and / or execute or implement software application processes and / or other modules, processes and / or functions to collect and analyze sensor data and / or to control stimulation of the brain. The underlying device technologies may be provided in a variety of component types, for example, Field Effect Transistor (FET) including metal-oxide semiconductor field-effect transistor (MOSFET) technologies like complementary metal-oxide semiconductor (CMOS), bipolar technologies like generative adversarial network (GAN), Bipolar CMOS (Bi-CMOS), Bipolar JunctionTransistors (BJT), Thin Film Transistors (TFT’s), polymer technologies (e.g., silicon-conju- gated polymer and metal-conjugated polymer-metal structures), mixed analog and digital, and / or the like. In some embodiments, FET and / or BJT may include materials such as, for example, Gallium Arsenide (GaAs), Gallium Nitride (GaN), Indium Phosphide (InP), Silicon Germanium (SiGe), and / or Silicon Carbide (SiC).

[0076] The memory 460 can be any suitable memory device(s) configured to store data, information, computer code or instructions (such as those described herein), and / or the like. In some embodiments, the memory 460 can be and / or can include one or more of a random access memory (RAM), static RAM (SRAM), dynamic RAM (DRAM), a memory buffer, an erasable programmable read-only memory (EPROM), an electrically erasable read-only memory (EEPROM), a read-only memory (ROM), flash memory, volatile memory, non-volatile memory, combinations thereof, and the like. In some embodiments, the memory 460 can store instructions to cause the processor 452 to execute modules, processes, and / or functions associated with collecting and analyze signals from the brain of the user, such as models, calculations, or other algorithms to analyze sensor data capture by the headset and / or image(s) or video(s) captured by an external device. In some embodiments, the memory 460 may also be configured to at least temporarily store sensor data, for example, until the data is transmitted to a user device or a remote server.

[0077] The communication interface(s) 454 can be any suitable device(s) and / or interface^) that can communicate with the, sensor(s), memory 460, processor 452, or other components of the headset and a network (e.g., a local area network (LAN), a wide area network (WAN), or the cloud) and / or an external device (e.g., a user device such as cell phone, tablet, a laptop, or a desktop computer, etc.). Moreover, the communication interface(s) 454 can include one or more wired and / or wireless interfaces, such as, for example, Ethernet interfaces, optical carrier (OC) interfaces, and / or asynchronous transfer mode (ATM) interfaces. In some embodiments, the communication interface(s) 454 can be, for example, a network interface card and / or the like that can include at least an Ethernet port and / or a wireless radio (e.g., a WIFI® radio, a BLUETOOTH® radio, cellular such as 3G, 4G, 5G, etc., 802.1 IX Zigbee, etc.). In some embodiments, the communication interface(s) 454 can include one or more satellite, WI-FI®, BLUETOOTH®, or cellular antenna. In some embodiments, the communication interface^) 454 can be communicably coupled to an external device (e.g., an external processor) that includes one or more satellite, WI-FI, BLUETOOTH®, or cellular antenna, or a power source such as a battery or a solar panel. 1

[0078] In some embodiments, the communication interface(s) 454 can be configured to receive signals from the optical detection assembly, the flex sensor(s), the electrode(s), the processor 452, or other components of the headset and to communicate those signals to an external device, e.g., for further processing and / or analysis. In some embodiments, the communication interface(s) 454 may also be configured to communicate signals from an external device to optical detection assembly, the flex sensor(s), the electrode(s), the processor 452, or other components of the headset, for example, an activation signal to activate the electrode(s). In some embodiments, the communication interface 454 may send information to one or more external devices (e.g., the compute device 180, the server 190, the database(s) 195) via the network (e.g., network 105). In some embodiments, the communication interface 454 may receive information (e.g., via the communication interface 454) from the one or more external devices. In some embodiments, the communication interface(s) 454 may be configured to communicate the electrical stimulation signal to the electrodes to cause the electrodes to deliver a treatment regimen or dose.[0(179] The I / O device(s) 456 may each be configured to interface with the user and relay to and from the processor 452 and the memory 460 of the headset. The I / O device(s) may include any suitable device configured to receive input from a user or communicate an output to the user. In some embodiments, the I / O device(s) may include an activation mechanism or otherwise, a user actuated element (e.g., a touch button, a push button, a switch, a touchpad, etc.) to turn on or otherwise, activate the headset including the optical detection assemblies, the flex resistors, and / or the electrodes.|0080| FIGS. 5-9 are various view of a neural device headset 500 (hereinafter, “headset 500”) configured to detect optical signals from a brain of a user, according to embodiments. As shown, the headset 500 includes a plurality of columns 510, 520, 530 coupled together by a plurality of flexible regions 540. The headset 500 including controller 550 may be structurally and / or functionally similar to the headsets 100, 200, 300, and controller 450, and therefore, certain details of the headset 500 including controller 550 are not described in further detail with respect to FIGS. 5-9.

[0081] For example, the headset 500 includes a first column 510, the first of column 510 including a first optical detection assembly 512 disposed on an inner surface thereof. The first optical detection assembly 512 includes a first light emitter 513, a first light detector 514a, and a second light detector 514b disposed on the inner surface of the first column 510. The headset 500 includes a second column 520. The second column 520 includes a second optical detectionassembly 522 disposed on an inner surface thereof and including a second light emitter 523, a third light detector 524a, and a fourth light detector 524b. As shown, the arrangement of the first optical detection assembly 512 on the first column 510 and the arrangement of the second optical detection assembly 522 on the second column 520 may be vertically mirrored. The headset 500 further includes a third column 530 disposed between the first column 510 and the second column 520. As shown, the third columns 530 includes an electrode 532 disposed on an inner surface thereof. In some embodiments, the electrode 532 may occupy all of or almost all of the inner surface of the third column 530.

[0082] The headset 500 may include a first set of columns 510. For example, the headset 500 may include a plurality of columns including the structure of the first column 510 described above. In some embodiments, the headset 500 may include a second set of columns 520 including the structure of the second column 520 described above. In some embodiments, the headset 500 may include a third set of columns 530 including the structure of the third column 530 described above. In some embodiments, the headset 500 may alternate between column types. For example, the headset 500 may include the following arrangement: the first column type 510 may be coupled to the third column type 530 on a first side of the third column type 530 by a corresponding flexible region 540 or flexible member, a second side of the third column type 530 may be coupled to a first side of the second column type 520 by a corresponding flexible region 540, a second side of the second column type 520 may be coupled to a first side of the third column type 530 by a corresponding flexible region 540, and a second side of the third column type 530 may be coupled to a first side of a first column type 510 by a corresponding flexible region 540, and so on and so forth. In some embodiments, the first side and the second side of each column may refer to lateral edges (e.g., left and / or right sides) of the columns. In some embodiments, the headset 500 may include 4 columns in the first set of columns 510, 4 columns in the second set of columns 520, and 7 columns in the third set of columns 530. One or more flex sensors may be disposed on at least a portion of (e.g., each of) the flexible regions 540. The flexible regions may be substantially similar in structure and function to the flexible regions 240, 240’, 340, 340’ and therefore, not described in further detail herein.

[0083] The headset 500 includes a first end component 551a and a second end component 551b, at least one of the first end component 551a and the second end component 551b may each define an inner volume including at least a portion of the controller 550 and / or at least a portion of the power source 553 disposed therein. For example, the first end component 551amay include the controller 550 disposed therein and the second end component 551b may include the power source 553 disposed therein. In some embodiments, the first end component 551a may include the power source 553 disposed therein and the second end component 551b may include the controller 550 disposed therein. As shown, the first and second end components 551a, 551b are rectangular; however, the first end component 551a and / or the second end component 551b may be any suitable shape such as, for example, a circle, an oval, a square, a triangle, a hexagon, etc. In some embodiments, the first end component 551a and / or the second end component 551b may include an I / O device 556 (e.g., a button or switch) configured to receive a user input to turn on the headset 500. In some embodiments, the I / O device 556 may be disposed on an outer surface of the first end component 551a and / or the second component 551b, as shown in FIGS. 5-9, for example, a surface facing away from a surface of the first end components 551a and / or the second end component 551b configured to contact the user.|0084| The headset 500 may include a securement member 570 coupled to the first end component 551a and the second end component 551b and configured to be disposed around a rear of the head of the user to support the plurality of columns 510, 520, 530 on the forehead of the user. The securement member 570 may be an adjustable strap or band configured to be coupled to a first connector 575a disposed on the first end component 551a and a second connector 575a coupled to the second end component 551b. As shown, the securement member 570 is disposed through an opening or loop defined by each of the first connector 575a and the second connector 575b and a portion of the securement member 570 may removably fasten to itself (e.g., via Velcro, adhesive, stitching, buttons, snap-fits, etc.). In some embodiments, a length of the securement member 570 may be adjusted by uncoupling the portion of the securement member 570, pulling the securement member 570 through the opening or loop of the first and / or second connectors 575a, 757b, and reattaching a larger or smaller portion of the securement member 570 to itself. In some embodiments, the securement member may include a stretchable band (e.g., an elastic band).10085] As shown in FIGS. 7-8, the flexible regions 540 are disposed between each of the plurality of columns 510, 520, 530 such that the headset 500 can conform to the horizontal curvature of the forehead of the user. The flexible regions 540 allow the plurality of columns 510, 520, 530 of the headset to form a “U” shape or semi-circular shape to accommodate the forehead of the user. The flexible regions 540 have a width and a length smaller than a width and a length of each of the plurality of columns 510, 520, 530. When the securement member570 is coupled to first end component 551a and the second end component 551b, the headset500 forms a substantially circular or oval shape corresponding to the head of the user.

[0086] FIGS. 10-12 depict a headset 600 disposed on a forehead of three different users, according to embodiments. The headset 600 may be structurally and / or functionally similar to the headset 500, and therefore certain aspects of the headset 600 are not described in further detail with respect to FIGS. 10-12. As shown, the headset includes a plurality of columns 610, 620, 630 coupled together by a plurality of flexible regions 640, that may include one or more flex sensors (e.g., disposed thereon or therewithin). More specifically, the headset 600 includes a first set of columns 610 each including an optical detection assembly, a second set of columns 620 each including an optical detection assembly, and a third set of columns 630 each optionally including an electrode. When the headset 600 is worn by the user, an inner surface of each of the plurality of columns 610, 620, 630 contact the forehead of the user. As shown, the headset 600 conforms to the horizontal and vertical curvature of the forehead of the user such that the inner surface of each of the plurality of columns 610, 620, 630 makes substantial contact with the skin of the user (e.g., greater than 80% of a light sensitive area of the inner surface of each of the columns 610, 620, 630 contact a corresponding portion of the head of the user). When worn by the user, the headset 600 may be aligned such that a column 620 is aligned along an axis extending vertically from a nose of the user.

[0087] FIGS. 13A-15 are various views of a headset 700 configured to be worn on a forehead of a user, according to embodiments. The headset 700 includes a plurality of columns 710, 720, 730 including optical detection assemblies and / or electrodes 732. As shown, the headset 700 includes a first set of columns 710 including an optical detection assembly 712, a second set of columns 720 including an optical detection assembly 722, and a third set of columns 730 interposing a respective column from the first set of columns 710 and a respective column from the second set of columns 720. The third set of columns 730 may include a first subset including an electrode 732 and a second subset not including an electrode. As shown, the second subset of the third set of columns 730 may be positioned near an anterior pole of the headset 700 (e.g., such that these columns are disposed near a center of the forehead of the user). The columns disposed near the anterior pole of the headset 700 may not include electrodes to prevent undesirable electrical stimulation at this area. In some embodiments, the columns disposed near the anterior pole of the headset 700 may include electrodes 732 configured to stimulate a corresponding portion of the user’s brain.

[0088] In some embodiments, the first set of columns 710 and the second set of columns 720 may have optical detection assemblies 712, 722 with the same or different arrangements of light emitters and light detectors. As shown, the first set of columns 710 and the second set of columns 720 have optical detection assemblies 712, 722 with the same arrangement of light emitters and light detectors. Different from the headset 500, 600, each optical detection assembly of headset 700 may include two light emitters 713a, 713b and four light detectors 714a, 714b, 714c, 714d. As shown, each column of the first set of columns 710 includes a first light emitter 713a and a second light emitter 713b and each column of the second set of columns 720 includes a first light emitter 723 a and a second light emitter 723b. Each column of the first set of columns 710 further includes a first light detector 714a, a second light detector 714b, a third light detector 714c, and a fourth light detector 714d. Each column of the second set of columns 520 further includes a first light detector 724a, a second light detector 724b, a third light detector 724c, and a fourth light detector 724d. The headset 700 may include 13 total columns, with 7 columns including optical detection assemblies 712, 722. In some embodiments, the headset 700 may include 4 columns including electrodes 732, and 2 columns including no sensors and / or electrodes (e.g., a bare surface column).|0089| FIG. 13B is a close-up view of a first column 710 including a plurality of light emitters and light detectors, according to embodiments. As shown, the first light emitter 713a and the first light detector 714a may have a first distance DI therebetween. The first light emitter 713a and the second light detector 714b have a second distance D2 greater than the first distance DI therebetween. The first light emitter 713a and the third light detector may have a third distance D3 greater than the first distance DI and the second distance D2. The first light emitter 713a and the fourth light detector 714d have a fourth distance D4 therebetween greater than the first distance DI, the second distance D2, and the third distance D3. The second light emitter 713b may be positioned the first distance DI from the fourth light detector 714d, a fifth distance D5 from the third light detector 714c, a sixth distance D6 from the second light detector 714b, and a seventh distance D7 from the first light detector 714a. The varying distances DI - D6 allow the optical detection assembly to measure light signals at varying depths in the user’s head and / or at varying areas of the brain.

[0090] Although not shown, the headset 700 may include a securement member configured to be coupled to a first end component 751a and a second end component 751b. The first end component 751a and / or the second end component 751b may include at least a portion of the controller 750 disposed therein and may include an I / O device 756 (e.g., a button) disposedthereon for turning on the headset 700. For example, the first end component 75 la may include the controller 750 disposed therein and the second end component 751b may include the power source disposed therein. In some embodiments, the first end component 751a may include the power source disposed therein and the second end component 751b may include the controller 750 disposed therein. Different from the headset 500, 600, the I / O device of headset 700 may be located on a sidewall of the first end component 751a and / or second end component 751b that is orthogonal to a sidewall of the housing that faces the user’s head. FIGS. 14-15 show a rear perspective view and a front view, respectively, of the headset 700.

[0091] FIG. 16 is a flow chart of an example method 80 of mapping anatomical regions of a brain of a user to one or more optical sensors of a neural device headset (e.g., headset 100, 200, 300, 500, 500, 700), according to embodiments. The method 80 may include measuring signals from a plurality of flex sensors disposed on a headset, the headset configured to be worn on a user’s forehead, at 81. At 82, the method includes determining a bending profile of the headset based on the signals from the one or more flex sensors. In some embodiments, the bending profile may include measurements representing a degree of bending at each flex sensor location. In some embodiments, the bending profile may include an average degree of bending across the entire headset determined from each of the flex sensors. In some embodiments, the bending profile may include information corresponding to an orientation of each of the optical sensors (e.g., based on interpolation from the flex sensor data). In some embodiments, the bending profile may define a radius of curvature across the entire headset.

[0092] In some embodiments, the method 80 may optionally include collecting image and / or video data of the headset disposed on the user’s head, at 83. In some embodiments, the image and / or video data may be collected using an imaging device (e.g., an imaging device on an external device such as a mobile phone or smart device). In some embodiments, the method 80 may optionally include creating a 3D model of the user’s head using the image and / or video data, at 84. The 3D model may be generated on the external device and / or the controller of the headset.

[0093] The method 80 may include determining a curvature (e.g., a horizontal curvature and / or a vertical curvature) of the user’s forehead, at 85. In some embodiments, the curvature may be determined based on the bending profile of the headset. For example, the curvature of the user’s forehead may correspond to the bending profile determined. In some embodiments, the curvature of the user’s forehead may be equivalent to the bending profile of the headset. In some embodiments, the 3D model of the user’s head may be used to determine the curvatureof the user’s forehead. In some embodiments, the each of the bending profile determined using the flex sensors of the head set and the 3D model obtained or determined from the imaging device may be used to determine the curvature of the user’s head. The method 80 may further include determining a position of a user’s brain relative to the headset based on the curvature of the user’s forehead, at 86. In some embodiments, the position of the user’s brain relative to the headset may be based on information such as common thicknesses of the skin, the skull, and / or the meninges.

[0094] The method 80 may include mapping each optical sensor disposed on the headset to an area of the user’s brain, at 87. For example, information related to a position of each optical sensor on the headset and information related to a position of one or more cortical areas based on known information of human anatomy may be used to determine which optical sensors is closest to a corresponding cortical area. In some embodiments, the mapping of each optical sensor to an area of the user’s brain may be based at least on a position of the optical sensor on the headset, an orientation of the optical sensor relative to the brain of the user, the curvature of the head of the user, and / or a distance between a light emitter and a light detector of the optical sensor (e.g., for a depth coordinate).

[0095] FIG. 17 is a flow chart of an example method 90 of treating a neurological or psychological condition (e.g., ADHD) and / or improving or enhancing a cognitive function (e.g., attention) using transcranial electrical stimulation. Operations of the method 90 may be performed using any of the devices herein (e.g., the headset 100, 200, 300, 500, 600, 700) or any device that can deliver electrical signals (e.g., current) to predetermined regions of the brain of a patient.

[0096] In some embodiments, the method 90 may optionally include collecting baseline information of a patient, at 91. For example, a baseline symptom level of a neurological or psychological condition may be collected or obtained via one or more symptom scales from the patient or user. In some embodiments, baseline cognitive function of the patient or user may optionally be collected. In some embodiments, information related to comorbid conditions may be collected. For example, information related to a presence or severity of depression of the patient or user may be collected. In some embodiments, treatment sessions may be provided to patients or users who have mild or moderate depression with ADHD. In some embodiments, treatment sessions may not be provided to patients or users who have severe depression with ADHD.

[0097] In some embodiments, the information may be collected using symptom scales including self-reported Conners’ Adult ADHD Raring Scales (CAARS) DSM-IV ADHD symptoms Subscales scores, self-reported Weiss Functional Impairment Rating Scale (WFIRS), the Depression, Anxiety, Stress Scale (DASS), or any other symptom determination or executive function and / or cognitive function determination method. In some embodiments, patient progress may be determined by tracking a user device usage (e.g., screen time, social media usage, etc.), as described in further detail below. In some embodiments, patient progress may be determined using brain activity (e.g., collected via electrical signals, imaging, fNFRS, etc.) and / or biological data (e.g., heart rate, biomarkers, etc.).

[0098] At 92, the method 90 may include delivering, in a treatment session, electrical stimulation to a head of the patient for a period of time, the electrical stimulation producing an effective electric field in a target brain region. In some embodiments, an applied current amplitude may be the current applied to the electrodes (e.g., via a controller or electronics system). In some embodiments, the applied current amplitude may be at least about 0.5 mA, at least about 0.6 mA, at least about 0.7 mA, at least about 0.8 mA, at least about 0.9 mA. In some embodiments, the applied current amplitude may be no greater than 2 mA, no greater than 1.5 mA, no greater than 1.3 mA, no greater than 1.2 mA, no greater than 1.1 mA, no greater than 1.0 mA, no greater than 0.9 mA, no greater than 0.85 mA. In some embodiments, the applied current amplitude may be in a range between about 0.5 mA and about 1.0 mA, inclusive of all ranges and subranges therebetween. In some embodiments, the applied current amplitude may be in a range between about 0.65 mA and about 0.85 mA, inclusive of all ranges and subranges therebetween. In some embodiments, the applied current amplitude may be about 0.75 mA. In some embodiments, the applied current amplitude may be determined based on one or more characteristics of the patient (e.g., symptoms, response level, etc.). In some embodiments, the applied current amplitude may be chosen from within the range of 0.5 mA to about 1.0 mA, inclusive.[00991 In some embodiments, the applied stimulation current may have an amplitude that is about 1, 2, 3, or 4 times the standard deviation of a random signal used as the stimulation signal (the amplitude being measured base to peak). In some embodiments, the applied stimulation current may have an amplitude that is about 3 times the standard deviation from the baseline current signal. For example, the applied stimulation current can include a tRNS signal having a baseline of 0.25 mA, and having a base to peak amplitude of 0.75 mA.

[0100] In some embodiments, the applied current may result in an effective electric field within the brain. In some embodiments, the system may apply a current sufficient to cause a predetermined or desired electric field at one or more target brain regions. In some embodiments, an applied current of about 0.75 mA can result in an effective electric field between about 0.10 V / m to about 0.25 V / m. In some embodiments, the effective electric field may be at least about 0.10 V / m, at least about 0.11 V / m, at least about 0.12 V / m, at least about 0.13 V / m, at least about 0.14 V / m, at least about 0.15 V / m, at least about 0.16 V / m, at least about 0.17 V / m, at least about 0.18 V / m, at least about 0.19 V / m, at least about 0.20 V / m, at least about 0.21 V / m, at least about 0.22 V / m, at least about 0.23 V / m, at least about 0.24 V / m at least about 0.25 V / m, at least about 0.26 V / m, at least about 0.27 V / m, at least about 0.28 V / m, or at least about 0.29 V / m. In some embodiments, the effective electric field may be no greater than about 0.30 V / m, no greater than about 0.29 V / m, no greater than about 0.28 V / m, no greater than about 0.27 V / m, no greater than about 0.26 V / m no greater than about 0.25 V / m, no greater than about 0.24 V / m, no greater than about 0.23 V / m, no greater than about 0.22 V / m, no greater than about 0.21 V / m, no greater than about 0.20 V / m, no greater than about 0.19 V / m, no greater than about 0.18 V / m, no greater than about 0.17 V / m, no greater than about 0.16 V / m, no greater than about 0.15 V / m, no greater than about 0.14 V / m, no greater than about 0.13 V / m, no greater than about 0.12 V / m, no greater than about 0.11 V / m.[01011 In some embodiments, the applied current amplitude and / or the effective electric field may be maintained below or above a predetermined threshold to prevent static symptoms or worsening symptoms (e.g., see FIG. 20B). In some embodiments, the predetermined threshold of the applied current may be about 1.5 mA and / or the predetermined threshold of the effective electric field may be about 0.3 V / m. In some embodiments, the applied current amplitude may be determined based on one or more physical characteristics of the patient (e.g., hair, skin conductivity, etc.) to cause the device to deliver the desired effective electric field to the brain of the patient.[01021 In some embodiments, the applied current amplitude at the electrodes may result in an effective current density at the target brain region. In some embodiments, an individualized dose (e.g., the effective electric field and / or the effective current density) may be determined for a user or patient. For example, the method 90 may optionally include applying various dose levels (e.g., applied current amplitude, effective current density, and / or effective electric field) to the user or patient and recording a user experience at each dose level. In some embodiments the dose levels delivered may be within a predetermined range. For example, the dose mayinclude the effective electric field and may have a lower threshold of about 0.1 V / m and an upper threshold of about 0.3 V / m. In some embodiments, an optimal dose may be the lowest dose in the range that leads to a desired outcome (e.g., lower inattentive symptoms, higher cognitive functioning, improved performance on tasks, etc.).[0103| In some embodiments, the method 90 may optionally include applying various dose levels to the user or patient and, for each dose, computing an activity measure and / or computing a measure based on an activity determination. The activity measure may be an outcome of the activity determination model. The activity determination may be based on a model that intakes stimulation data, brain data, and / or task data and outputs a level of brain activity in response to the stimulation dose delivered. In some embodiments, an optimal dose may be the dose that maximizes the activity measure, which can be indicative of brain activity levels of the patient or user. The optimal dose delivered to the patient or user according to the method 90 may be such that it causes the brain activity levels to be corrected or improved for an expected therapeutic outcome from the given dose.

[0104] In some embodiments, the electrical stimulation may include at least one of tran- scranial random noise stimulation (tRNS), transcranial direct current stimulation (tDCS), tran- scranial alternating current stimulation (tACS), transcranial pulsed current stimulation (tPCS), or any suitable type of transcranial electrical stimulation. In some embodiments, tRNS may be administered. In some embodiments, the electrical stimulation may be delivered via a stimulation system (e.g., any of the systems or devices described herein). In some embodiments, the stimulation system may include one or more electrodes. The one or more electrodes may be mounted on a headset (e.g., any of the devices and systems described herein). In some embodiments, one or more predetermined target brain regions (e.g., in a prefrontal cortex of the user) may be stimulated, as described in further detail below with respect to FIGS. 18-19C. In some embodiments, the electrodes (e.g., electrodes of the headset) may be disposed over any one of AF7, AF8, Fpl, or Fp2 regions of the brain of the user or patient. In some embodiments, the electrodes may be disposed over any one of F3, F4, AFF5h, AFF6h, AF5h, AF6h, F5, F6, AFF7h, or AFF8h. In some embodiments, the electrical stimulation may be delivered through a first electrode placed over the AF7 region and a second electrode placed over the AF8 region. In some embodiments, the first electrode may be placed over AFF5h and the second electrode may be placed over AFF6h. In some embodiments, the electrodes for delivery current may have a surface area in a range of about 7 cm2to about 30 cm2, inclusive of all ranges and subranges therebetween. In some embodiments, the electrodes for delivering current may havea surface area in a range of about 6 cm2to about 12 cm2, inclusive of all ranges and subranges therebetween. In some embodiments, the surface area of each of the electrodes may be at least 6 cm2, at least about 7 cm2, at least about 8 cm2, at least about 9 cm2, at least about 10 cm2, at least about 11 cm2. In some embodiments, the surface area of each of the electrodes may be no more than 30 cm2, no more than about 25 cm2, no more than about 20 cm2, no more than about 18 cm2, no more than about 15 cm2, no more than about 12 cm2, no more than about 11 cm2, no more than about 10 cm2, no more than about 9 cm2, no more than about 8 cm2, no more than about 7 cm2. In some embodiments, the surface area may be about 9 cm2.

[0105] In some embodiments, the electrical stimulation may be delivered for a predetermined duration or period of time in a treatment session. In some embodiments, the predetermined duration of the treatment session may be between about 10 minutes to about 60 minutes. In some embodiments, the predetermined duration of the treatment session may be at least about 10 minutes, at least about 12 minutes, at least about 15 minutes, at least about 18 minutes, at least about 20 minutes, at least about 25 minutes, at least about 30 minutes, at least about 45 minutes, or at least about 60 minutes, inclusive. In some embodiments, the predetermined duration of the treatment session may be no greater than about 60 minutes, no greater than about 45 minutes, no greater than about 30 minutes, no greater than about 25 minutes, no greater than about 20 minutes, no greater than about 18 minutes, no greater than about 15 minutes, no greater than about 12 minutes. In some embodiments, the predetermined duration of the treatment session may be between about 15 minutes and about 60 minutes, inclusive of all ranges and subranges therebetween. In some embodiments, the treatment session may be about 15 minutes. In some embodiments, the treatment session may be about 20 minutes. In some embodiments, the electrical stimulation may be delivered continuously during the predetermined duration or period of time of the treatment session. In some embodiments, electrical stimulation may be delivered in a plurality of treatment sessions per day. In some embodiments, electrical stimulation may be delivered for at least about 10 minutes per day and no more than about 60 minutes per day over one or more treatment sessions per day.

[0106] At 94, the method may optionally include instructing or prompting the patient or user to perform one or more tasks during the treatment session (e.g., during the electrical stimulation). For example, the patient or user may be instructed to play a game configured to improve attention symptoms. In some embodiments, the patient or user may be instructed to perform tasks chosen by the patient or user (e.g., work tasks, school tasks, etc.). In some embodiments, performing the one or more tasks during the treatment session may enhanceeffectiveness of the electrical stimulation and / or improve results of the treatment. In some embodiments, each treatment session may be delivered in a home setting. For example, the patient or user may be instructed to undergo the treatment session at home or in any other non-clinical setting.

[0107] In some embodiments, the patient or user may be prompted to undergo a predetermined number of treatments per day. In some embodiments, one treatment session may be administered in a day. In some embodiments, two treatment sessions may be administered in a day. In some embodiments, a variable number of treatment sessions may be delivered in a day (e.g., variable over a week and / or variable over a treatment course). In some embodiments, a number of treatment sessions delivered per day may be in a range between about one treatment session and about 5 treatment sessions, inclusive of all ranges and subranges therebetween. In some embodiments, a number of treatment sessions delivered per day may be in a range between about one treatment session and about 3 treatment sessions, inclusive of all ranges and subranges therebetween. In some embodiments, 1 treatment session, 2 treatment sessions, 3 treatment sessions, 4 treatment sessions, or 5 treatment sessions may be delivered per day. In some embodiments, the treatment sessions delivered in a day or delivered in a week may have variable lengths (e.g., in a range of about 15 minutes to about 60 minutes per session). In some embodiments, the treatment sessions delivered in a day or delivered in a week may have the same duration. In some embodiments, a number of sessions per day may correspond to a duration of each treatment session. For example, a total duration of electrical stimulation per day may not exceed 60 minutes.|0108| At 96, the method may include repeating the treatment session a predetermined number of days per week over a plurality of weeks to treat the neurological or psychological condition and / or to improve executive / cognitive function. In some embodiments, the patient or user may be prompted or instructed to undergo the treatment session the predetermined number of days per week over the plurality of weeks. In some embodiments, the headset including the electrodes may be operatively coupled to a controller or processor (e.g., controller 150) and / or a user interface (e.g., on a user device such as a smartphone, on compute device 180, etc.) configured to alert a patient to schedule and / or undergo a treatment session (e.g., via alarms, text notifications, email notifications, badges, haptic feedback, automated phone calls, etc.) that may be communication to the patient or the patient’ s caretaker (e.g., via a device associated with the patient or the patient’s caretaker). In some embodiments, the controller or processor may be configured to determine a schedule or calendar of the patient (e.g., using the patient’ssmartphone or other personal device) and prompt the user to undergo the treatment session when the patient has free time (e.g., when a meeting is not scheduled on a calendar of the patient’s user device). In some embodiments, the controller or processor may prompt the patient or user to undergo the treatment session alongside a paired activity such as a focused work session. In some embodiments, the processor may be configured to cause a user device to alert the patient or user (e.g., via a calendar, reminder application, system notification, etc.)

[0109] In some embodiments, the patient or user may be administered at least 3 treatment sessions per week, at least 4 treatment sessions per week at least 5 treatment sessions per week, at least 6 treatment sessions per week, at least 7 treatment sessions per week, at least 8 treatment sessions per week, at least 9 treatment sessions per week, at least 10 treatment sessions per week, at least 12 treatment sessions per week, at least 13 treatment sessions per week, at least 14 treatment sessions per week, at least 20 treatment sessions per week, at least 30 treatment sessions per week. In some embodiments, the user may be administered up to 35 treatment sessions per week.

[0110] In some embodiments, the patient or user may be administered a predetermined number of treatment sessions a day (e.g., between one treatment session and 5 treatment sessions) for at least 3 days per week, at least 4 days per week, at least 5 days per week, at least 6 days per week, or 7 days per week. In some embodiments, the patient or user may be administered one treatment session a day for at least 3 days per week, at least 4 days per week, at least 5 days per week, at least 6 days per week, or 7 days per week. In some embodiments, the patient or user may be administered 2 sessions per day for at least 3 days per week, at least 4 days per week, at least 5 days per week, at least 6 days per week, or 7 days per week. In some embodiments, the patient or user may be administered the predetermined number of treatment sessions per week over a plurality of weeks. For example, the user may be administered the predetermined number of treatment sessions per week over at least 2 weeks, at least 3 weeks, at least 4 weeks, at least 5 weeks, at least 6 weeks, at least 7 weeks, at least 8 weeks. In some embodiments, the patient or user may be administered the treatment sessions indefinitely (e.g., a lifetime treatment, until symptoms fall below a threshold level, or as needed). In some embodiments, the number of treatment sessions per week may vary over the course of the treatment. In some embodiments, the number of treatments per week may decrease over time (e.g., a reduced regimen) as symptoms improve. For example, the treatment sessions may be delivered daily for up to about 3 months and then reduced to about 3 to 5 days per week to maintain the threshold level. In some embodiments, the treatment sessions may be delivered daily for up toabout 3 months and then reduced to about 3 to 5 sessions per week to maintain the threshold level. In some embodiments, the number of treatments per week may increase over time if symptoms worsen. ioini In some embodiments, the device or system may deliver (or the user may be instructed to undergo) one treatment session per day for at least 3 days per week, with a duration of each treatment session being about 15 minutes to about 60 minutes. In some embodiments, the device or system may deliver (or the user may be instructed to undergo) one treatment session per day for 3, 4, 5, or 6 days per week, with a duration of each treatment session being about 15 minutes to about 60 minutes. In some embodiments, the device or system may deliver (or the user may be instructed to undergo) two treatment sessions per day for at least 3 days per week, with a duration of each treatment session being about 15 minutes to about 60 minutes. In some embodiments, the device or system may deliver (or the patient or user may be instructed to undergo) two treatment sessions per day for 3, 4, 5, or 6 days per week, with a duration of each treatment session being about 15 minutes to about 60 minutes.

[0112] In some embodiments, the patient or user may be administered treatment sessions(i.e., electrical stimulation may be delivered) while the patient or user is taking medication for ADHD. In some embodiments, the patient or user may be administered treatment sessions (i.e., electrical stimulation may be delivered) while the user is not taking medication for ADHD.[01131 In some embodiments, the method 90 may optionally include collecting information from the patient or user over the course of the treatment, at 98. For example, the information may be collected from the patient or user via at least one of (i) one or more symptoms scales at one or more time points over the plurality of weeks of the treatment, (ii) a mobile device usage over the plurality of weeks, and / or (iii) biosignal data such as brain activity (e.g., fNIRS, EEG, etc.). In some embodiments, the brain activity may be collected at predetermined intervals (e.g., daily, every other day, every couple days, every week, etc.) In some embodiments, the system (e.g., the controller or user interface) may prompt the patient or user to fill out symptom scales or surveys. In some embodiments, the system may automatically (e.g., with user permission) collect data from the mobile device usage of the user. In some embodiments, the information from the patient or user may be collected at predetermined time points throughout the treatment. For example, the information may be collected every week, every 2 weeks, every 3 weeks, every 4 weeks, or at any suitable time interval. In some embodiments, the information collected may be used to track patient progress and / or to determine a treatment plan for the patient. In some embodiments, one or more characteristics of the treatment sessionsmay be adjusted based on the information collected from the patient (e.g., a frequency of treatment sessions, a duration of sessions, etc.). For example, a different treatment regime (a reduced regimen) may be administered after the patient or user has achieved a desired benefit (or maximum benefit).[0114| FIG. 18 shows coordinates for electrode placement on a head 802 of a user according to the 10-5 EEG electrode placement system. In some embodiments, the electrodes may be placed over one or more targets (i.e., locations on a user’s head corresponding to target regions in a user’s brain such as the prefrontal cortex) to deliver electrical stimulation (e.g., tRNS) to a corresponding target brain region (e.g., according to the 10-20 EEG electrode placement system or the 10-5 EEG electrode placement system). In some embodiments, one or more predetermined target brain regions may be stimulated. The boxes in FIG. 18 show possible target brain regions for stimulation. In some embodiments, the electrodes (e.g., electrodes of the headset) may be disposed over any one of AF7, AF8, Fpl, or Fp2 regions of the brain. In some embodiments, the electrodes may be disposed over, or approximately over any one of F3, F4, AFF5h, AFF6h, AF5h, AF6h, F5, F6, AFF7h, and / or AFF8h, or any suitable combination thereof. In some embodiments, the corresponding target brain regions may be at least one of a left lateral prefrontal cortex, a right lateral prefrontal cortex, a medial prefrontal cortex, a boundary region between the medial prefrontal cortex and the left lateral prefrontal cortex, or a boundary region between the medial prefrontal cortex and the right lateral prefrontal cortex. In some embodiments, the electrical stimulation may be delivered through a first electrode placed over the AF7 region and a second electrode placed over the AF8 region. In some embodiments, the electrical stimulation may be delivered through a first electrode placed over or near the AFF5h region 804a and a second electrode placed over or near the AFF6h region 804b.

[0115] FIGS. 19A-19C show effective electric fields resulting from placing electrodes at the AFF5h and AFF6h. As shown, the region R2 denoted with a dotted line corresponds to an effective electric field of zero or close to zero and the region R1 denoted with a solid line is an effective electric field between 0.1 V / m and 0.3 V / m. In some embodiments, the electric field pattern shown in FIGS. 19A-19C may be the desirable result from stimulation. Arrows shown in FIGS. 19B-19C are for illustrative purposes only.

[0116] The following sections illustrate example treatment sessions performed on patients in clinical studies using the dosages and treatment methodologies described herein. These examples are for illustrative purposes only and should not be construed as limiting the disclosure in any way or form.Clinical Trial comparing 0.75mA tRNS treatment to sham tRNS:

[0117] A double-blind randomized control trial study was conducted over a four-week period. Participants were adults ages 18 to 40. Participants were split into a treatment group and a sham group. Transcranial random noise stimulation (tRNS) with an applied current amplitude (e.g., dosage) of 0.75 mA was administered to participants in the treatment group and sham (or control / placebo group) tRNS (e.g., Only a short ramp-up and ramp-down used to blind participants, otherwise 0 mA current applied) was administered to participants in the sham group. The tRNS and sham were administered through electrodes having a surface area of 9 cm2placed over regions near AFF5h and AFF6h. Treatment sessions were provided in an at-home setting. Both groups were prescribed one 20-minute session on 6 out of 7 days per week.

[0118] ADHD symptoms were measured using self-reported Conners’ Adult ADHD Raring Scales (CAARS) DSM-IV ADHD symptoms subscales scores. Functional impairment was measured by the self-report Weiss Functional Impairment Rating Scale (WFIRS). Emotional distress symptoms were measured by the Depression, Anxiety, Stress Scale (DASS). Symptom measurements were taken at week 0 (baseline), week 2 (mid-treatment), week 4 (post-treatment), and week 6 (follow-up).

[0119] Data was analyzed for participants who completed at least 15 treatment sessions and had valid survey responses, resulting in n = 31 participants for the treatment group and n = 27 participants in the sham group. Results showed a reduction in inattentive symptoms at post-treatment (e.g., week 4) following 0.75 mA tRNS compared to sham tRNS (d = 0.3, p < 0.107).

[0120] Subgroup analyses were conducted to identify treatment responders. A first subgroup included participants who believed they had received treatment rather than sham and who actually did receive treatment and included n = 13 participants. A second subgroup included participants who believed they had received treatment but had received sham and included n = 13 participants. The first subgroup reported significantly lower inattentive symptoms at post-treatment (week 4) than the second subgroup (d = 0.59, p < 0.043). For the first subgroup and the second subgroup, n = 10 participants filled out scales at the follow-up (week 6). Participants from the first subgroup reported significantly lower inattentive symptoms at the follow-up (week 6) compared to participants from the second subgroup (d = 0.75, p < 0.022), which may be evidence of positive neuroplastic improvements. Additionally, there wasa reduction in total ADHD symptoms in the first subgroup compared to sham at post-treatment (d = 0.51, p < 0.058) and follow-up (d = 0.53, p < 0.077).

[0121] In the same subgroup analysis, there was significantly greater improvement in DASS anxiety subscale scores in the first subgroup (e.g., received tRNS) compared to the second subgroup (e.g., received sham) at follow up (d = 0.59, p < 0.33) and a trend for greater improvement in DASS stress scores in the first subgroup compared to the second subgroup at follow up (d = 0.59, p < 0.075). Participants also trended reduced functional impairment at post-treatment in the first subgroup compared to the second subgroup in the WFIRS family skills subscale (d = 0.67, p < 0.07), self-image subscale (d = 0.48, p < 0.081), and risk subscale (d = 0.52, p < 0.1).

[0122] Lastly, participants in the treatment group not taking antidepressant medication during the tRNS treatment period (n = 24) trended greater improvements in lower inattentive symptoms at post treatment than participants in the sham group not taking antidepressants (n = 18) (d = 0.38, p < 0.089).

[0123] Participants were not able to reliably tell tRNS apart from sham tRNS on the basis of sensation on the skin, meaning blinding was successful. Because blinding was successful, these results suggest that participants who may have received ADHD symptom improvements from tRNS had insight into their symptom improvement, and were able to attribute it to the treatment.Clinical Trial showing response to 0.75mA tRNS treatment versus 1.5mA tRNS treatment:

[0124] A double-blind randomized control trial study was conducted over a four-week period to compare tRNS using different effective electric fields. Participants were adults ages 18 to 40. A first treatment group (i.e., the 0.75 mA group) received tRNS treatment having an applied current amplitude of 0.75 mA (measured base-to-peak) and a second treatment group (i.e., the 1.5 mA group) received tRNS treatment having an applied current amplitude of 1.5 mA (measured base-to-peak). The baseline of the simulation waveform was 0 mA (as shown in FIG. 21 A). tRNS was administered through electrodes having a surface area of 9 cm2placed over regions near AFF5h and AFF6h. Treatment sessions were provided in an at-home setting. Both groups were prescribed one 20-minute session on 6 out of 7 days per week. ADHD symptoms were measured using the CAARS, WFIRS, and DASS scales. Symptom measurementswere taken at week 0 (baseline), week 2 (mid-treatment), week 4 (post-treatment), and week 6 (follow-up).

[0125] Data was analyzed for participants who completed at least 15 treatment sessions and had valid survey responses, resulting in n = 30 participants for the 0.75 mA group and n = 25 patients for the 1.5 mA group. There was a trend for reduced inattentive symptoms at posttreatment following 0.75 mA tRNS treatment (n = 31) compared to sham tRNS (n = 27), (d = 0.3, p < 0.107). Participants trended reduced functional impairment at post-treatment (week 4) after 0.75 mA tRNS treatment compared to 1.5 mA tRNS treatment in the WFIRS family skills subscale (d = 0.42, p < 0.074), with the trend persisting into follow-up (week 6) (d = 0.4, p < 0.098). This suggests a potential non-linear dose response curve for tRNS (i.e., stochastic resonance). Participants also trended lower social impairment (d = 0.37, p < .078) and risk impairment (d = 0.37, p < 0.079) at follow-up after 0.75 mA tRNS treatment compared to 1.5 mA tRNS treatment.

[0126] There was a trend for more improvement in DASS anxiety symptoms after 0.75mA tRNS than 1.5mA tRNS at post-treatment (d = 0.31, p < 0.092), that persisted into follow-up (d = 0.28, p< 0.094). There was also a trend for more improvement in DASS stress symptoms after 0.75mA tRNS than 1.5mA tRNS at follow-up (d = 0.38, p < 0.075).

[0127] Follow-up subgroup analyses were conducted to identify treatment responders. Participants who believed that they had received treatment rather than sham in a post-treatment survey reported significantly lower inattentive symptoms at post-treatment following tRNS (n = 13) compared to sham tRNS (n = 13), d = 0.59, p < 0.043. Inattentive symptoms in this subgroup were also lower after tRNS compared to sham at two-week follow-up (d = 0.75, p < 0.022). There were also trends for reduced Total ADHD symptoms in the 0.75mA group compared to sham at post-treatment (d = 0.51, p < 0.058) and follow-up (d = 0.53, p < 0.077). The difference in Total ADHD symptoms was significant for 0.75mA tRNS over 1.5mA tRNS at post-treatment (d = 0.65, p < 0.016) and follow-up (d = 0.76, p < 0.01), which is also an indicator of stochastic resonance.

[0128] In the same subgroup analysis, participants trended reduced functional impairment at post-treatment after 0.75 mA tRNS treatment compared to sham tRNS treatment in the WFIRS family skills subscale (d = 0.67, p < 0.07), self-image subscale (d = 0.48, p < 0.081), and risk subscale (d = 0.52, p < 0.1). Participants also trended lower overall functional impairment at post-treatment after 0.75 mA tRNS treatment compared to 1.5mA treatment (d = 0.48,p < 0.055). A similar trend was present in the family subscale at post-treatment (d = 0.54, p < 0.089), which became significant at follow-up (d = 0.76, p < 0.023). Life skills subscale scores were significantly lower after 0.75 mA tRNS treatment compared to 1.5 mA tRNS at posttreatment (d = 0.58, p < 0.022) and follow-up (d = 0.58, p < 0.044). Self-image subscale scores were lower after 0.75 mA tRNS treatment compared to 1.5 mA tRNS at post-treatment (d = 0.71, p < 0.006) and follow-up (d = 0.84, p < 0.009).

[0129] There was significantly greater improvement in DASS anxiety subscale scores in the 0.75 mA tRNS group over sham tRNS at follow-up (d = 0.59, p < 0.033). The difference was also significant for 0.75 mA tRNS over 1.5 mA tRNS at post-treatment (d = 0.65, p < 0.023) and follow-up (d = 0.58, p < 0.016). These results indicate a lack of neuroplastic effect at higher doses.

[0130] There was a trend for greater improvement in DASS stress scores in the 0.75 mA group over sham at follow-up (d = 0.59, p < 0.075). The difference was again significant for 0.75mA tRNS over 1.5 mA tRNS at post-treatment (d = 0.81, p < 0.008) and follow-up (d = 0.88, p < 0.008). DASS depression scores were also significantly lower for those who received 0.75 mA tRNS compared to 1.5 mA tRNS at post-treatment (d = 0.69, p < 0.021) and followup (d = 1.11, p < 0.002).

[0131] Finally, in a subgroup of participants who were not taking antidepressant medication during the tRNS treatment period, there was a trend for lower Inattentive symptoms at post-treatment after 0.75 mA tRNS treatment (n = 24) compared to sham tRNS (n = 18), d = 0.38, p < 0.089).

[0132] FIGS. 20A-20B show graphs of the clinical data gathered in the experiments described above. As shown in FIG. 20A, the treatment group that received 0.75 mA tRNS and the sham group (0mA) start with similar average inattentive scores at baseline, but the 0.75mA treatment groups shows a greater decrease in inattentive symptoms at week 4 and week 6 than the sham group. These results show that the benefit of the stimulation treatment is apparent very shortly after initiating treatment (e.g., within 2-4 weeks) and are neuroplastic (e.g., benefits remain at week 6 after treatment ends). The patients who receive tRNS may experience between a 10% improvement and a 70% improvement of at least one symptom related to ADHD and / or cognitive / executive functioning. As shown, the patients who receive tRNS may experience at least about a 10% improvement, at least about a 20% improvement, at least abouta 30% improvement, at least about a 40% improvement, at least about a 50% improvement, at least about a 60% improvement, or at least about a 70% improvement in inattentive symptoms.

[0133] FIG. 20B is a box plot showing a difference in inattentive symptom improvement between the sham group (0 mA), the 0.75 mA treatment group, and the 1.5 mA treatment group. As shown, the 0.75 mA group has a higher improvement in inattentive symptoms than the sham group and the 1.5 mA treatment group. These results suggest a dose-response curve based on the results from the clinical study, and the dose response curve may be non-linear, showing possible stochastic resonance. The results suggest a predetermined range of applied current amplitude (e.g., current applied through the electrodes) results in higher improvement in scale scores than applied current amplitudes outside of the predetermined range. For example, as shown, 0.75 mA delivered through the electrodes may fall within the more effective dose range than 1.5 mA. Additionally, the results suggest a predetermined range of effective electric field (e.g., between about 0.1 V / m and 0.3 V / m) and the predetermined regions of the prefrontal cortex (e.g., AFF5h and AFF6) may result in higher improvement in scale scores than effective electric fields outside of the predetermined range.

[0134] FIG. 21A is a plot of an example waveform of an electrical stimulation signal that can be used to treat a neurological or psychological disorder and / or improve executive / cogni- tive function. This shows noise levels included in electrical stimulations provided to a patient’s brain using the systems and methods described herein. As shown in FIG. 21 A, the current amplitude of the stimulation signal may be about 3 standard deviations from the baseline current signal. The stimulation signal includes a ramp up phase, a delivery phase, and a ramp down phase. In some embodiments, the baseline of the stimulation waveform may be about 0 mA.

[0135] FIG. 21B shows example transcranial random noise stimulation (tRNS) waveforms applied to one or more regions of a brain of a user to treat ADHD. Current amplitude, as referred to herein, may refer to a base-to-peak value of the tRNS waveform. The waveform can be bidirectional with a base-to-peak value (i.e., a current amplitude). As shown, each panel shows different noise levels applied to the signal. The top left panel shows no noise, the top right panel shows weak noise, the bottom left panel shows optimal or desired noise, and the bottom right panel shows high noise. During treatment sessions, the waveform in the bottom left panel shown in FIG. 21 A may be delivered to a head of the user via one or more electrodes (e.g., via a headset including one or more electrodes as described herein).

[0136] FIG. 21C shows an inverse “U” curve illustrating the stochastic resonance on the level of individual neuronal firing. Stochastic resonance occurs when noise increases the sensitivity of the system to weak signals and can improve transmission of those weak signals in the brain. As shown, the signal to noise ratio (SNR) increases for a range of noise intensities and drops off for noise intensities that are above and below this range, where the signal is the neuronal firing that is desired to occur, and the added noise is due to the applied stimulation. Therefore, delivering a stimulation waveform with a noise intensity in the desired range may improve response of the target regions by increasing sensitivity to weak neuronal signals (e.g., increasing the SNR of the activity in the target region).

[0137] In some embodiments, a system, comprising: a wearable device including a plurality of electrodes configured to be disposed over a region of a prefrontal cortex of a patient when the wearable device is worn by the patient; and a controller operatively coupled to the plurality of electrodes and configured to: cause the plurality of electrodes to deliver a treatment session, the treatment session including delivery of transcranial random noise stimulation (tRNS) to the region of the prefrontal cortex with a current amplitude in a range of about 0.5 milliamps (mA) to about 2 mA for a period of time.

[0138] In some embodiments, the region of the prefrontal cortex includes a left lateral prefrontal cortex, a right lateral prefrontal cortex, a medial prefrontal cortex, a boundary region between the medial prefrontal cortex and the left lateral prefrontal cortex, or a boundary region between the medial prefrontal cortex and the right lateral prefrontal cortex.

[0139] In some embodiments, the period of time is in a range of about 15 minutes to about 60 minutes.10140 [ In some embodiments, the current amplitude at which the plurality of electrodes is activated is in a range of about 0.5 mA to about 1 mA.

[0141] In some embodiments, the current amplitude at which the plurality of electrodes is activated is in a range of about 0.65 mA to about 0.85 mA.

[0142] In some embodiments, a surface area of each of the plurality of electrodes is in a range of about 6 cm2to about 12 cm2.10143] In some embodiments, the plurality of electrodes include a first electrode and a second electrode, the wearable device configured to support the first electrode over a first region of the prefrontal cortex near AFF5h and the second electrode over a second region of the prefrontal cortex near AFF6h.

[0144] In some embodiments, the current amplitude causes at least a 20% improvement in inattentive symptoms of the patient.10145] In some embodiments, a method of treating attention-deficit / hyperactivity disorder (ADHD) in a patient, the method comprising: delivering transcranial random noise stimulation (tRNS) to a region of a prefrontal cortex of the patient for a time period, the tRNS causing an effective electric field at the region of the prefrontal cortex in a range of about 0.1 Volts / meter (V / m) to about 0.30 V / m.

[0146] In some embodiments, the region of the prefrontal cortex includes a left lateral prefrontal cortex, a right lateral prefrontal cortex, a medial prefrontal cortex, a boundary region between the medial prefrontal cortex and the left lateral prefrontal cortex, or a boundary region between the medial prefrontal cortex and the right lateral prefrontal cortex.

[0147] In some embodiments, the time period is in a range of about 15 minutes to about 60 minutes.

[0148] In some embodiments, the tRNS is delivered a predetermined number of times per week over a plurality of weeks.

[0149] In some embodiments, the tRNS includes activating one or more electrodes at a current amplitude sufficient to deliver the effective electric field at the region of the prefrontal cortex.

[0150] In some embodiments, the one or more electrodes includes a first electrode disposed near AFF5h, and a second electrode disposed near AFF6h.

[0151] In some embodiments, the tRNS is delivered at least 6 times per week over at least 4 weeks.

[0152] In some embodiments, delivering the tRNS is via one or more electrodes each having a surface area in a range of about 6 cm2to about 12 cm2.

[0153] In some embodiments, the tRNS is delivered in a home setting.

[0154] In some embodiments, the tRNS is delivered while the patient is not taking medication for the ADHD.

[0155] In some embodiments, the tRNS is delivered a plurality of times over at least 4 weeks, wherein the effective electric field causes at least a 20% improvement in inattentive symptoms of the patient.

[0156] In some embodiments, a method, comprising: delivering, via one or more electrodes, electrical stimulation causing an effective electrical field at one or more predetermined regions of a prefrontal cortex of a user while the user performs a task, wherein the electrical stimulation is delivered for at least about 15 minutes and up to about 60 minutes per day, at least once a day, and between 4 days per week and 7 days per week, to treat an attention deficit disorder or to enhance attention of the user.

[0157] In some embodiments, the one or more predetermined regions of the prefrontal cortex includes a left lateral prefrontal cortex, a right lateral prefrontal cortex, a medial prefrontal cortex, a boundary region between the medial prefrontal cortex and the left lateral prefrontal cortex, or a boundary region between the medial prefrontal cortex and the right lateral prefrontal cortex.

[0158] In some embodiments, the effective electric field is in a range of about 0.1 V / m to about 0.3 V / m.|0159[ In some embodiments, the electrical stimulation is delivered between once a day and four times a day.

[0160] In some embodiments, the electrical stimulation is delivered via one or more electrodes, a surface area of each of the one or more electrodes in a range of about 6 cm2to about 12 cm2.10161] In some embodiments, the electrical stimulation is delivered in a home setting.[01621 In some embodiments, the electrical stimulation is delivered while the user is not taking medication for the attention deficit disorder.

[0163] In some embodiments, the electrical stimulation is delivered while the user is taking medication for the attention deficit disorder.

[0164] In some embodiments, the electrical stimulation is tRNS.

[0165] In some embodiments, the electrical stimulation is delivered once a day for 6 days per week.

[0166] In some embodiments, the electrical stimulation is delivered a plurality of times over at least one month, wherein the effective electric field causes at least a 20% improvement in inattentive symptoms of the user.

[0167] In some embodiments, a headset configured to be worn on a forehead of a user, the headset comprising: a first column including a first optical sensor, the first column configured to contact the forehead of the user; a second column including a second optical sensor, the second column configured to contact the forehead of the user; a flexible member coupling the first column to the second column, the flexible member configured to allow the first column and the second column to articulate relative to one another; and a controller operatively coupled to the first optical sensor and the second optical sensor, the controller configured to cause the first optical sensor to detect a first optical signal and the second optical sensor to detect a second optical signal, at least one of the first optical signal and the second optical signal associated with a brain activity of the user.

[0168] In some embodiments, the first optical sensor includes a first light emitter and at least two light detectors, and the second optical sensor includes a second light emitter and at least two light detectors.[01691 In some embodiments, the first optical sensor includes a first pair of light emitters and four light detectors, and the second optical sensor includes a second pair of light emitters and four light detectors.

[0170] In some embodiments, the flexible member is a first flexible member, the headset further comprising a third column interposed between the first column and the second column, the first flexible member coupling the first column to the third column at a first side of the third column; and a second flexible member coupling the second column to the third column at a second side of the third column opposite the first side.

[0171] In some embodiments, the third column includes an electrode configured to contact the forehead of the user, the electrode configured to selectively stimulate an area of interest of the brain of the user.

[0172] In some embodiments, the flexible member allows the first column and the second column to bend about a first axis to cause the headset to conform to a horizontal curvature of the forehead of the user.

[0173] In some embodiments, the first column and the second column define a curvature along their respective lengths about a second axis orthogonal to the first axis such that the headset accommodates a vertical curvature of the forehead of the user.

[0174] In some embodiments, the first column and the second column are configured to be disposed proximate to an area of interest of a brain of the user when the headset is worn on the forehead of the user.

[0175] In some embodiments, the flexible member includes: a flex sensor configured to generate an electrical signal indicative of a degree of bending of the flex sensor.

[0176] In some embodiments, the controller is further configured to: determine a bend profile of the headset based on the signals output by the flex sensor; determine a curvature of the forehead of the user based on the bend profile of the headset; determine a position of the brain of the user relative to the headset based on the curvature of the forehead of the user; and map the first optical sensor to a first area of the user’ s brain and the second optical sensor to a second area of the user’s brain.

[0177] In some embodiments, the controller is further configured to: receive a model signal indicative of a three dimensional (3D) model of a head of a user developed based on one or more images of the user’s head captured by an imaging device, and determine the curvature of the forehead of the user based also on the 3D model of the user’s head.

[0178] In some embodiments, the first optical sensor and the second optical sensor are configured to: detect a first signal indicative of a brain blood oxygenation of the user; and detect a second signal indicative of a scalp blood oxygenation of the user.10179] In some embodiments, the headset further includes: a securement member configured to be disposed around a back of the user’s head to secure the first column and the second column on the forehead of the user.

[0180] In some embodiments, a width of the first column and a width of the second column are greater than a width of the flexible member.

[0181] In some embodiments, the headset includes between 2 columns and 30 columns.|O182] Various concepts may be embodied as one or more methods, of which at least one example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments. Put differently, it is to be understood that such features may not necessarily be limited to a particular order of execution, but rather, any number of threads, processes, services, servers, and / or the like that may executeserially, asynchronously, concurrently, in parallel, simultaneously, synchronously, and / or the like in a manner consistent with the disclosure. As such, some of these features may be mutually contradictory, in that they cannot be simultaneously present in a single embodiment. Similarly, some features are applicable to one aspect of the innovations, and inapplicable to others.

[0183] In addition, the disclosure may include other innovations not presently described. Applicant reserves all rights in such innovations, including the right to embodiment such innovations, file additional applications, continuations, continuations-in-part, divisionals, and / or the like thereof. As such, it should be understood that advantages, embodiments, examples, functional, features, logical, operational, organizational, structural, topological, and / or other aspects of the disclosure are not to be considered limitations on the disclosure as defined by the embodiments or limitations on equivalents to the embodiments. Depending on the particular desires and / or characteristics of an individual and / or enterprise user, database configuration and / or relational model, data type, data transmission and / or network framework, syntax structure, and / or the like, various embodiments of the technology disclosed herein may be implemented in a manner that enables a great deal of flexibility and customization as described herein.

[0184] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0185] As used herein, in particular embodiments, the terms “about” or “approximately” when preceding a numerical value indicates the value plus or minus a range of 10%. Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the disclosure. That the upper and lower limits of these smaller ranges can independently be included in the smaller ranges is also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.

[0186] The phrase “and / or,” as used herein in the specification and in the embodiments, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multipleelements listed with “and / or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and / or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and / or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.

[0187] As used herein in the specification and in the embodiments, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items in a list, “or” or “and / or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of’ or “exactly one of,” or, when used in the embodiments, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e., “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.” “Consisting essentially of,” when used in the embodiments, shall have its ordinary meaning as used in the field of patent law.

[0188] As used herein in the specification and in the embodiments, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, “at least one of A and B” (or, equivalently, “at least one of A or B,” or, equivalently “at least one of A and / or B”) can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionallyincluding more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.

[0189] In the embodiments, as well as in the specification above, all transitional phrases such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “holding,” “composed of,” and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases “consisting of’ and “consisting essentially of’ shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.[01901 While specific embodiments of the present disclosure have been outlined above, many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, the embodiments set forth herein are intended to be illustrative, not limiting. Various changes may be made without departing from the spirit and scope of the disclosure. Where methods and steps described above indicate certain events occurring in a certain order, those of ordinary skill in the art having the benefit of this disclosure would recognize that the ordering of certain steps may be modified and such modification are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. The embodiments have been particularly shown and described, but it will be understood that various changes in form and details may be made.

Claims

Claims1. A system, comprising: a wearable device including a plurality of electrodes configured to be disposed over a region of a prefrontal cortex of a patient when the wearable device is worn by the patient; and a controller operatively coupled to the plurality of electrodes and configured to: cause the plurality of electrodes to deliver a treatment session, the treatment session including delivery of transcranial random noise stimulation (tRNS) to the region of the prefrontal cortex with a current amplitude in a range of about 0.5 milliamps (mA) to about 2 mA for a period of time.

2. The system of claim 1, wherein the region of the prefrontal cortex includes a left lateral prefrontal cortex, a right lateral prefrontal cortex, a medial prefrontal cortex, a boundary region between the medial prefrontal cortex and the left lateral prefrontal cortex, or a boundary region between the medial prefrontal cortex and the right lateral prefrontal cortex.

3. The system of claim 1, wherein the period of time is in a range of about 15 minutes to about 60 minutes.

4. The system of claim 1, wherein the current amplitude at which the plurality of electrodes is activated is in a range of about 0.5 mA to about 1 mA.

5. The system of claim 1, wherein the current amplitude at which the plurality of electrodes is activated is in a range of about 0.65 mA to about 0.85 mA.

6. The system of claim 1, wherein a surface area of each of the plurality of electrodes is in a range of about 6 cm2to about 12 cm2.

7. The system of claim 1, wherein the plurality of electrodes include a first electrode and a second electrode, the wearable device configured to support the first electrode over a first region of the prefrontal cortex near AFF5h and the second electrode over a second region of the prefrontal cortex near AFF6h.

8. The system of claim 1, wherein the current amplitude causes at least a 20% improvement in inattentive symptoms of the patient.

9. A method of treating attention-deficit / hyperactivity disorder (ADHD) in a patient, the method comprising: delivering transcranial random noise stimulation (tRNS) to a region of a prefrontal cortex of the patient for a time period, the tRNS causing an effective electric field at the region of the prefrontal cortex in a range of about 0.1 Volts / meter (V / m) to about 0.30 V / m.10 The method of claim 9, wherein the region of the prefrontal cortex includes a left lateral prefrontal cortex, a right lateral prefrontal cortex, a medial prefrontal cortex, a boundary region between the medial prefrontal cortex and the left lateral prefrontal cortex, or a boundary region between the medial prefrontal cortex and the right lateral prefrontal cortex.

11. The method of claim 9, wherein the time period is in a range of about 15 minutes to about 60 minutes.

12. The method of claim 9, wherein the tRNS is delivered a predetermined number of times per week over a plurality of weeks.

13. The method of claim 9, delivering the tRNS includes activating one or more electrodes at a current amplitude sufficient to deliver the effective electric field at the region of the prefrontal cortex.

14. The method of claim 13, wherein the one or more electrodes includes a first electrode disposed near AFF5h, and a second electrode disposed near AFF6h.

15. The method of claim 9, wherein the tRNS is delivered at least 6 times per week over at least 4 weeks.

16. The method of claim 9, wherein delivering the tRNS is via one or more electrodes each having a surface area in a range of about 6 cm2to about 12 cm2.

17. The method of claim 9, wherein the tRNS is delivered in a home setting.

18. The method of claim 9, wherein the tRNS is delivered while the patient is not taking medication for the ADHD.

19. The method of claim 9, wherein the tRNS is delivered a plurality of times over at least 4 weeks, wherein the effective electric field causes at least a 20% improvement in inattentive symptoms of the patient.

20. A method, comprising: delivering, via one or more electrodes, electrical stimulation causing an effective electrical field at one or more predetermined regions of a prefrontal cortex of a user while the user performs a task, wherein the electrical stimulation is delivered for at least about 15 minutes and up to about 60 minutes per day, at least once a day, and between 4 days per week and 7 days per week, to treat an attention deficit disorder or to enhance attention of the user.

21. The method of claim 20, wherein the one or more predetermined regions of the prefrontal cortex includes a left lateral prefrontal cortex, a right lateral prefrontal cortex, a medial prefrontal cortex, a boundary region between the medial prefrontal cortex and the left lateral prefrontal cortex, or a boundary region between the medial prefrontal cortex and the right lateral prefrontal cortex.

22. The method of claim 20, wherein the effective electric field is in a range of about 0.1 V / m to about 0.3 V / m.

23. The method of claim 20, wherein the electrical stimulation is delivered between once a day and four times a day.

24. The method of claim 20, wherein the electrical stimulation is delivered via one or more electrodes, a surface area of each of the one or more electrodes in a range of about 6 cm2to about 12 cm2.

25. The method of claim 20, wherein the electrical stimulation is delivered in a home setting.

26. The method of claim 20, wherein the electrical stimulation is delivered while the user is not taking medication for the attention deficit disorder.

27. The method of claim 20, wherein the electrical stimulation is delivered while the user is taking medication for the attention deficit disorder.

28. The method of claim 20, wherein the electrical stimulation is tRNS.

29. The method of claim 20, wherein the electrical stimulation is delivered once a day for 6 days per week.

30. The method of claim 20, wherein the electrical stimulation is delivered a plurality of times over at least one month, wherein the effective electric field causes at least a 20% improvement in inattentive symptoms of the user.

31. A headset configured to be worn on a forehead of a user, the headset comprising: a first column including a first optical sensor, the first column configured to contact the forehead of the user; a second column including a second optical sensor, the second column configured to contact the forehead of the user; a flexible member coupling the first column to the second column, the flexible member configured to allow the first column and the second column to articulate relative to one another; and a controller operatively coupled to the first optical sensor and the second optical sensor, the controller configured to cause the first optical sensor to detect a first optical signal and the second optical sensor to detect a second optical signal, at least one of the first optical signal and the second optical signal associated with a brain activity of the user.

32. The headset of claim 31, wherein: the first optical sensor includes a first light emitter and at least two light detectors, and the second optical sensor includes a second light emitter and at least two light detectors.

33. The headset of claim 31, wherein: the first optical sensor includes a first pair of light emitters and four light detectors, and the second optical sensor includes a second pair of light emitters and four light detectors.

34. The headset of claim 31, wherein the flexible member is a first flexible member, the headset further comprising:a third column interposed between the first column and the second column, the first flexible member coupling the first column to the third column at a first side of the third column; and a second flexible member coupling the second column to the third column at a second side of the third column opposite the first side.

35. The headset of claim 34, wherein the third column includes an electrode configured to contact the forehead of the user, the electrode configured to selectively stimulate an area of interest of the brain of the user.

36. The headset of claim 30, wherein the flexible member allows the first column and the second column to bend about a first axis to cause the headset to conform to a horizontal curvature of the forehead of the user.

37. The headset of claim 36, wherein the first column and the second column define a curvature along their respective lengths about a second axis orthogonal to the first axis such that the headset accommodates a vertical curvature of the forehead of the user.

38. The headset of claim 31 , wherein the first column and the second column are configured to be disposed proximate to an area of interest of a brain of the user when the headset is worn on the forehead of the user.

39. The headset of claim 31, wherein the flexible member includes: a flex sensor configured to generate an electrical signal indicative of a degree of bending of the flex sensor.

40. The headset of claim 39, wherein the controller is further configured to: determine a bend profile of the headset based on the signals output by the flex sensor; determine a curvature of the forehead of the user based on the bend profile of the headset; determine a position of the brain of the user relative to the headset based on the curvature of the forehead of the user; and map the first optical sensor to a first area of the user’s brain and the second optical sensor to a second area of the user’s brain.

41. The headset of claim 31, wherein the controller is further configured to: receive a model signal indicative of a three dimensional (3D) model of a head of a user developed based on one or more images of the user’s head captured by an imaging device, and determine the curvature of the forehead of the user based also on the 3D model of the user’s head.

42. The headset of claim 31, wherein the first optical sensor and the second optical sensor are configured to: detect a first signal indicative of a brain blood oxygenation of the user; and detect a second signal indicative of a scalp blood oxygenation of the user.

43. The headset of claim 31, further comprising: a securement member configured to be disposed around a back of the user’s head to secure the first column and the second column on the forehead of the user.

44. The headset of claim 31, wherein a width of the first column and a width of the second column are greater than a width of the flexible member.

45. The headset of claim 31, wherein the headset includes between 2 columns and 30 columns.

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