Wearable devices, systems, and methods for assessing and / or modulating neurological conditions

Abstract

A wearable device for assessing and / or modulating a neurological condition of a subject is provided, the wearable device comprising a headset frame, an EEG module, and a tDCS module, the EEG electrodes being positioned proximate to or in contact with a first region of the subject and the tDCS electrode being positioned to or in contact with a second region of the subject when the headset frame is worn on the subject's head. Other example embodiments are described herein. In some embodiments, the wearable device has a compact, portable, and simple design, and its size and shape are set to accommodate different sizes and shapes of the subject's head while the EEG electrodes and the tDCS electrode can accurately and efficiently target desired target regions of the subject.

Description

Related applications

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 789,435, filed April 16, 2025, and U.S. Application No. 19 / 647,897, filed April 15, 2026, the entire contents of which are hereby incorporated by reference. Technical Field

[0002] This invention generally relates to devices, systems, and methods for assessing and modulating neurological conditions in subjects. More specifically, this invention relates to devices, systems, and methods for AI-based comprehensive diagnostic and therapeutic interventions for cognitive and neurophysiological conditions using personalized noninvasive brain stimulation (NIBS) technology. Background Technology

[0003] Although the mood symptoms of depression are usually well managed, cognitive impairment (COI) remains underdiagnosed and untreated.

[0004] Existing assessment tools rely on qualitative measurements, lacking diagnostic utility and standardized criteria. Furthermore, there are no clinical guidelines for the management of cognitive symptoms, and patients often face long waiting times. Therefore, in current treatment paradigms, approximately 45% (and possibly more) of cognitive symptoms remain uncontrolled. There is a need for devices and systems that can improve the diagnosis and management of cognitive impairment. Summary of the Invention

[0005] In light of the foregoing background, alternative solutions are provided for devices, systems, and methods for assessing and modulating neurological conditions in subjects.

[0006] Therefore, the exemplary embodiments disclosed herein provide a wearable device for assessing and modulating neurological disorders in a subject, the wearable device comprising: (a) a head-mounted device frame; (b) at least one electroencephalogram (EEG) module; (c) at least one transcranial direct current stimulation (tDCS) module; and (d) a wireless communication module for communicating with a remote server, wherein the at least one EEG module, the at least one tDCS module, and the wireless communication module are disposed on or housed within the head-mounted device frame and are communicatively connected to each other, wherein the at least one EEG module is configured to acquire at least one set of EEG data from the subject wearing the wearable device, wherein the wireless communication module is configured to transmit the at least one set of EEG data to the remote server for analysis and to receive a tDCS protocol from the remote server, wherein the tDCS protocol is determined based on the analysis of the at least one set of EEG data, and wherein the at least one tDCS module is configured to stimulate at least one target brain region of the subject wearing the wearable device according to the tDCS protocol.

[0007] Another example embodiment of this disclosure provides a wearable device for assessing and modulating neurological conditions in a subject, the wearable device comprising: a head-mounted device frame; at least one electroencephalogram (EEG) module; at least one transcranial direct current stimulation (tDCS) module; and a wireless communication module for communicating with a remote server, wherein the at least one EEG module, the at least one tDCS module, and the wireless communication module are disposed on or housed within the head-mounted device frame and are communicatively connected to each other, wherein the at least one EEG module is configured to receive wearable... The device provides at least one set of EEG data from the subject, wherein the wireless communication module is configured to transmit the at least one set of EEG data to the remote server for analysis and to receive a tDCS protocol from the remote server, wherein the tDCS protocol is determined based on the analysis of the at least one set of EEG data, wherein the at least one tDCS module is configured to stimulate at least one target brain region of the subject wearing the wearable device according to the tDCS protocol, wherein the at least one tDCS module includes a plurality of tDCS electrodes, each tDCS electrode being configured to use an amplitude of approximately 1.A current of 5 mA to approximately 2 mA is used to stimulate at least a portion of the target brain region of the subject, wherein the size and shape of the head-mounted device frame are configured to substantially conform to the contour of the subject's head portion, wherein the head-mounted device frame further includes: a central portion, the size and shape of which are configured to rest on at least a portion of the top of the subject's head, the central portion including a first side and a second side opposite to the first side; a first arm portion extending from the first side, the first arm portion including a first proximal arm portion and a first flexed arm portion, the size and shape of which are configured to substantially conform to the shape of the subject's right ear; and a second arm portion extending from the second side, the second arm portion including a second proximal arm portion and a second flexed arm portion, the size and shape of which are configured to substantially conform to the shape of the subject's left ear, wherein the at least one tDCS module includes a plurality of tDCS electrodes disposed on the inner side of the second proximal arm portion, such that when the subject wears the wearable device, the plurality of tDCS electrodes... The tDCS electrodes are located near the F3 region of the subject's brain. The at least one EEG module includes multiple EEG electrodes disposed on the inner side of the first bent arm portion, such that when the subject wears the wearable device, the multiple EEG electrodes are located near the T4 region of the subject's brain. The neurological conditions include cognitive impairment (COI), anxiety disorder, depression, and / or attention deficit hyperactivity disorder (ADHD). The wearable device further includes a processing unit configured to analyze the at least one set of EEG data and determine the tDCS protocol. The wearable device further includes a heart rate sensor module configured to acquire at least one set of heart rate data from the subject. The wearable device further includes a rechargeable battery and optionally a battery charging port. The wearable device further includes a wearing status module configured to determine the wearing status of the wearable device, including an on-head status and an off-head status. The wearing status module includes an infrared sensor.

[0008] Another example embodiment of this disclosure provides a system for assessing and modulating neurological disorders in a subject, the system comprising: (a) at least one wearable device as described in any of the preceding embodiments; (b) a server communicatively connected to the at least one wearable device via the wireless communication module, the server comprising: an artificial intelligence (AI) module configured to: (i) analyze at least one set of EEG data obtained from at least one EEG module of each wearable device to generate at least one assessment of neurological disorders in the subject wearing the wearable device; and (ii) generate a tDCS protocol based on the at least one assessment, such that the tDCS protocol is tailored to the neurological disorders of the subject; and (iii) wherein the server is configured to transmit the tDCS protocol to the wearable device, and the at least one tDCS module is configured to stimulate the target brain region of the subject according to the tDCS protocol.

[0009] Another example embodiment of this disclosure provides a method for assessing and modulating a subject's neurological condition using a system as described in any of the foregoing embodiments, the method comprising the steps of: obtaining at least one set of EEG data of the subject wearing the wearable device by the at least one EEG module; transmitting the at least one set of EEG data to the server by the wireless communication module of the wearable device; analyzing the at least one set of EEG data by the AI ​​module to generate at least one assessment of the subject's neurological condition; generating the tDCS protocol by the AI ​​module based on the at least one assessment, such that the tDCS protocol is customized according to the subject's neurological condition; transmitting the tDCS protocol to the wireless communication module of the wearable device by the server; and executing the tDCS protocol by the at least one tDCS module to stimulate the target brain region of the subject.

[0010] Another example embodiment of this disclosure provides a wearable device for assessing and / or modulating neurological conditions in a subject, the wearable device comprising: (a) a headband frame; (b) an electroencephalography (EEG) module including at least one EEG electrode; and (c) a transcranial direct current stimulation (tDCS) module including at least one tDCS electrode, wherein the EEG module is configured to acquire at least one set of EEG data from the subject; wherein the tDCS module is configured to stimulate at least one target brain region of the subject; and wherein the headband frame further comprises: (a1) a headband including a central portion, a first arm portion, and a second arm portion, the size and shape of the headband being configured to at least span a first region of the subject's head, wherein the central portion is configured to hold the at least one EEG electrode; (a2) A tDCS electrode holder is configured to hold at least one tDCS electrode, wherein, when the head-mounted device frame is worn on the subject's head, the at least one EEG electrode is positioned near or in contact with a first target area, and the at least one tDCS electrode is positioned to or in contact with a second target area on the subject's head.

[0011] Another example embodiment of this disclosure provides a wearable device for assessing and / or modulating neurological conditions in a subject, the wearable device comprising: (a) a head-mounted device frame; (b) an electroencephalography (EEG) module including two EEG electrodes; and (c) a transcranial direct current stimulation (tDCS) module including three tDCS electrodes; (d) a wireless communication module for communicating with at least one terminal and optionally at least one remote server; (f) a rechargeable battery and a battery charging port optionally electrically connected to the EEG module and the tDCS module; and (h) A processing unit configured to analyze the at least one set of EEG data and determine a tDCS protocol, wherein the EEG module is configured to acquire at least one set of EEG data from the subject; wherein the tDCS module is configured to stimulate at least one target brain region of the subject; wherein the wireless communication module is configured to transmit the at least one set of EEG data to a terminal or a remote server for analysis, and is configured to receive the tDCS protocol from the terminal or the remote server; and wherein the head-mounted device frame further includes: (a1) a headband comprising a central portion, a first arm portion, an opposite second arm portion, and a flexible EEG support band extending from or attached to the inner surface of the central portion, and the three EEG electrodes being positioned on the EEG support band, the size and shape of the headband being set to at least span the T4 and / or FP1 regions of the subject's head, wherein the central portion is configured to hold the three EEG electrodes; (a2) A tDCS electrode holder, comprising a lateral electrode holding portion and a neck portion, is configured to hold two tDCS electrodes. The neck portion is integral with or attached to the central portion on its lower side, and integral with or attached to the lateral electrode holding portion on its upper side. The neck portion is configured to be switchable at least between a retracted position and an extended position. When the head-mounted device frame is worn on the subject's head, at least one EEG electrode is... The at least one tDCS electrode is positioned near or in contact with the FP1 and / or FP2 regions of the subject's head, and is positioned in or in contact with the F3 and / or F4 regions of the subject's head; wherein each of the tDCS electrodes includes a plurality of conductive silicone electrodes arranged to form a comb or brush configuration, each of the two tDCS electrodes includes a plurality of conductive silicone electrodes arranged to form a comb or brush configuration, and the two tDCS electrodes are positioned at or near both ends of the lateral electrode holding portion and are slidably movable relative to the lateral electrode holding portion;Furthermore, the tDCS protocol is determined based on the analysis of the at least one set of EEG data, and the at least one tDCS module is configured to stimulate at least one target brain region of the subject wearing the wearable device according to the tDCS protocol, and each comb-shaped or brush-shaped conductive silicone electrode is configured to stimulate at least a portion of the target brain region of the subject with a current of approximately 1.5 mA to approximately 2 mA.

[0012] Another example embodiment of this disclosure provides a system for assessing and / or modulating neurological disorders in a subject, the system comprising: (a) at least one wearable device of this disclosure; (b) at least one terminal; and (c) optionally, at least one remote server, wherein the at least one terminal and optionally the at least one remote server are communicatively connected to each of the at least one wearable device, wherein the system is configured to: (i) analyze at least one set of EEG data obtained from the EEG module of the wearable device to generate at least one assessment of neurological disorders in the subject wearing the wearable device; and / or (ii) generate a tDCS protocol based on the at least one assessment, such that the tDCS protocol is tailored to the neurological disorders of the subject, wherein the tDCS module is configured to stimulate at least one target brain region of the subject according to the tDCS protocol.

[0013] Another example embodiment of this disclosure provides a method for assessing and / or modulating a neurological condition in a subject, the method comprising the steps of: (a) obtaining at least one set of EEG data of the subject wearing the wearable device of this disclosure by at least one EEG module; (b) optionally, transmitting the at least one set of EEG data to a terminal or a remote server by a wireless communication module of the wearable device; (c) analyzing the at least one set of EEG data by the at least one wearable device, the at least one terminal, and / or the at least one remote server to generate at least one assessment of the neurological condition in the subject; (d) generating a tDCS protocol based on the at least one assessment by the at least one wearable device, the at least one terminal, and / or the at least one remote server, such that the tDCS protocol is customized according to the neurological condition in the subject; (e) optionally, transmitting the tDCS protocol to the wireless communication module of the wearable device by the at least one terminal and / or the at least one remote server; and (f) executing the tDCS protocol by the tDCS module to stimulate at least one target brain region of the subject.

[0014] Other example embodiments will be described below.

[0015] The various embodiments disclosed herein have many advantages. In some embodiments, the provided apparatus, system, and method are capable of: (i) Use electroencephalography (EEG) to quantify cognition; (ii) Identify EEG biomarkers indicating cognitive impairment (COI); and (iii) Use artificial intelligence (AI) technology to apply personalized transcranial direct current stimulation (tDCS) protocols targeting these biomarkers.

[0016] In some embodiments, a closed-loop system is provided, comprising (i) a wireless hybrid EEG-tDCS electrode for simultaneous EEG recording and tDCS delivery, and (ii) an AI algorithm for detecting EEG abnormalities and adjusting treatment intensity in real time. Data regarding biomarkers and treatment are securely shared with physicians, enabling remote monitoring. In some embodiments, the provided devices, systems, and methods improve adherence to and efficacy of antidepressants, which are often hindered by poor working memory, by enhancing the cognitive performance of subjects with depression.

[0017] In some embodiments, the provided device can be used as a home medical device to address the underdiagnosis and undertreatment of cognitive symptoms in subjects with depression.

[0018] In some embodiments, the provided devices, systems, and methods may be used by depressed subjects to prevent relapse.

[0019] In some embodiments, the provided device has a compact, portable and simple design, and its size and shape are set to adapt to different sizes and shapes of the subject's head, while the EEG electrodes and tDCS electrodes can accurately and efficiently target the subject's desired target area. Attached Figure Description

[0020] Figure 1A This is a top view of a wearable device for assessing and modulating neurological conditions in a subject, according to an example embodiment.

[0021] Figure 1B Is with Figure 1A A perspective view of the wearable device of the same example embodiment shown.

[0022] Figure 1C Is with Figure 1A A front view of the wearable device of the same example embodiment shown.

[0023] Figure 1D Is with Figure 1A The right-side view of the wearable device of the same example embodiment shown.

[0024] Figure 2A This is a front view of an example wearable device worn by the subject.

[0025] Figure 2B It is based on and Figure 2A A top view of an example wearable device worn by a subject, representing the same example embodiment as shown.

[0026] Figure 2C It is based on and Figure 2A A stereoscopic view of an example wearable device worn by a subject, showing the same example embodiment.

[0027] Figure 3 This is a schematic diagram illustrating examples of corresponding brain locations recorded by EEG electrodes and stimulated by tDCS electrodes when a subject is wearing a wearable device.

[0028] Figure 4 This is a schematic diagram of an example wearable device.

[0029] Figure 5 This is a schematic diagram of another example of a wearable device.

[0030] Figure 6 This is a circuit diagram of an example wearable device.

[0031] Figure 7 This is a circuit diagram of an example wearable device that includes a tDCS module.

[0032] Figure 8A This is a stereoscopic view of another example wearable device for assessing and modulating a subject's neurological condition, according to an example embodiment.

[0033] Figure 8B Is with Figure 8A A top view of the wearable device of the same example embodiment shown.

[0034] Figure 8C Is with Figure 8A A bottom view of the wearable device of the same example embodiment shown.

[0035] Figure 8D Is with Figure 8A A side view of the wearable device of the same example embodiment shown.

[0036] Figure 8E yes Figure 8A The example wearable device is shown as a side view of the subject wearing it.

[0037] Figure 8F It is based on and Figure 8AA stereoscopic view of an example wearable device worn by a subject, showing the same example embodiment.

[0038] Figure 8G It is based on and Figure 8A A front view of an example wearable device worn by a subject, showing the same example embodiment.

[0039] Figure 9 This is a schematic diagram of an example system for assessing and / or modulating neurological conditions in subjects.

[0040] Figure 10 This is a schematic diagram of an example method for assessing and / or modulating a subject's neurological condition using an example system. Detailed Implementation

[0041] In some embodiments, a wearable device is provided for assessing and modulating neurological disorders in a subject, the wearable device comprising: (a) a head-mounted device frame; (b) at least one electroencephalogram (EEG) module; (c) at least one transcranial direct current stimulation (tDCS) module; and (d) a wireless communication module for communicating with a remote server, wherein the at least one EEG module, the at least one tDCS module, and the wireless communication module are disposed on or housed within the head-mounted device frame and are communicatively connected to each other, wherein the at least one EEG module is configured to acquire at least one set of EEG data from the subject wearing the wearable device, wherein the wireless communication module is configured to transmit the at least one set of EEG data to the remote server for analysis and to receive a tDCS protocol from the remote server, wherein the tDCS protocol is determined based on the analysis of the at least one set of EEG data, and wherein the at least one tDCS module is configured to stimulate at least one target brain region of the subject wearing the wearable device according to the tDCS protocol.

[0042] In some embodiments, the at least one tDCS module includes a plurality of tDCS electrodes, each tDCS electrode being configured to stimulate at least a portion of the target brain region of the subject with a current of about 1.5 mA to about 2 mA.

[0043] In some embodiments, the size and shape of the head-mounted device frame are configured to substantially conform to the contour of the subject's head portion, and wherein the head-mounted device frame further includes: a central portion, the size and shape of which are configured to rest on at least a portion of the top of the subject's head, the central portion including a first side and a second side opposite to the first side; a first arm portion extending from the first side, the first arm portion including a first proximal arm portion and a first arm bend portion, the size and shape of which are configured to substantially conform to the shape of the subject's right ear; and a second arm portion extending from the second side, the second arm portion including a second proximal arm portion and a second arm bend portion, the size and shape of which are configured to substantially conform to the shape of the subject's left ear.

[0044] In some embodiments, the at least one tDCS module includes a plurality of tDCS electrodes disposed on the medial side of the proximal portion of the second arm, such that when the subject wears the wearable device, the plurality of tDCS electrodes are located near the F3 region of the subject's brain.

[0045] In some embodiments, the at least one EEG module includes a plurality of EEG electrodes disposed on the inside of the first bent portion of the arm, such that when the subject wears the wearable device, the plurality of EEG electrodes are located near the T4 region of the subject's brain.

[0046] In some embodiments, the neurological disorders include cognitive impairment (COI), anxiety disorder, depression, and / or attention deficit hyperactivity disorder (ADHD).

[0047] In some embodiments, the wearable device further includes a processing unit configured to analyze the at least one set of EEG data and determine the tDCS scheme.

[0048] In some embodiments, the wearable device further includes a heart rate sensor module configured to acquire at least one set of heart rate data of the subject.

[0049] In some embodiments, the wearable device further includes a rechargeable battery and optionally a battery charging port.

[0050] In some embodiments, the wearable device further includes a wearing status module configured to determine the wearing status of the wearable device, wherein the wearing status includes a head-on state and an off-head state of the subject.

[0051] In some embodiments, the wearing status module includes an infrared sensor.

[0052] In some embodiments, a wearable device is provided for assessing and modulating neurological conditions in a subject, the wearable device comprising: a head-mounted frame; at least one electroencephalogram (EEG) module; at least one transcranial direct current stimulation (tDCS) module; and a wireless communication module for communicating with a remote server, wherein the at least one EEG module, the at least one tDCS module, and the wireless communication module are disposed on or housed within the head-mounted frame and are communicatively connected to each other, wherein the at least one EEG module is configured to acquire at least one set of EEG data from the subject wearing the wearable device, wherein the wireless communication module is configured to transmit the at least one set of EEG data to the remote server for analysis and to receive a tDCS protocol from the remote server, wherein the tDCS protocol is determined based on the analysis of the at least one set of EEG data, wherein the at least one tDCS module is configured to stimulate at least one target brain region of the subject wearing the wearable device according to the tDCS protocol, wherein the at least one tDCS module includes a plurality of tDCS electrodes, each tDCS electrode being configured to use an amplitude of approximately 1.A current of 5 mA to approximately 2 mA is used to stimulate at least a portion of the target brain region of the subject, wherein the size and shape of the head-mounted device frame are configured to substantially conform to the contour of the subject's head portion, wherein the head-mounted device frame further includes: a central portion, the size and shape of which are configured to rest on at least a portion of the top of the subject's head, the central portion including a first side and a second side opposite to the first side; a first arm portion extending from the first side, the first arm portion including a first proximal arm portion and a first flexed arm portion, the size and shape of which are configured to substantially conform to the shape of the subject's right ear; and a second arm portion extending from the second side, the second arm portion including a second proximal arm portion and a second flexed arm portion, the size and shape of which are configured to substantially conform to the shape of the subject's left ear, wherein the at least one tDCS module includes a plurality of tDCS electrodes disposed on the inner side of the second arm proximal portion, such that when the subject wears the wearable device, the plurality of tDCS electrodes are located in the... The wearable device is located near the F3 region of the subject's brain. The at least one EEG module includes multiple EEG electrodes disposed on the inner side of the bent portion of the first arm, such that when the subject wears the wearable device, the multiple EEG electrodes are located near the T4 region of the subject's brain. The neurological conditions include cognitive impairment (COI), anxiety disorder, depression, and / or attention deficit hyperactivity disorder (ADHD). The wearable device further includes a processing unit configured to analyze the at least one set of EEG data and determine the tDCS protocol. The wearable device further includes a heart rate sensor module configured to acquire at least one set of heart rate data from the subject. The wearable device further includes a rechargeable battery and optionally a battery charging port. The wearable device further includes a wearing status module configured to determine the wearing status of the wearable device, including a head-on state and an off-head state. The wearing status module includes an infrared sensor.

[0053] In some embodiments, a system for assessing and modulating neurological disorders in a subject is provided, the system comprising: (a) at least one wearable device as described in any of the preceding embodiments; (b) a server communicatively connected to the at least one wearable device via the wireless communication module, the server comprising: an artificial intelligence (AI) module configured to: (i) analyze at least one set of EEG data obtained from at least one EEG module of each wearable device to generate at least one assessment of neurological disorders in the subject wearing the wearable device; and (ii) generate a tDCS protocol based on the at least one assessment, such that the tDCS protocol is tailored to the neurological disorders of the subject; and (iii) wherein the server is configured to transmit the tDCS protocol to the wearable device, and the at least one tDCS module is configured to stimulate the target brain region of the subject according to the tDCS protocol.

[0054] In some embodiments, the server is a cloud-based platform wirelessly connected to the at least one wearable device via the wireless communication module.

[0055] In some embodiments, the neurological disorders include cognitive impairment (COI), anxiety disorder, depression, and / or attention deficit hyperactivity disorder (ADHD).

[0056] In some embodiments, a method is provided for using the system to assess and modulate a subject's neurological condition, the method comprising the steps of: (a) obtaining at least one set of EEG data of the subject wearing the wearable device by the at least one EEG module; (b) transmitting the at least one set of EEG data to the server by the wireless communication module of the wearable device; (c) analyzing the at least one set of EEG data by the AI ​​module to generate at least one assessment of the subject's neurological condition; (d) generating the tDCS protocol by the AI ​​module based on the at least one assessment, such that the tDCS protocol is customized according to the subject's neurological condition; (e) transmitting the tDCS protocol to the wireless communication module of the wearable device by the server; and (f) executing the tDCS protocol by the at least one tDCS module to stimulate the target brain region of the subject.

[0057] In some embodiments, prior to step (a), the method further includes the following steps: (i) obtaining at least one set of training EEG data from a reference data source labeled by a set of neurological symptoms and / or a set of tDCS schemes; (ii) training the AI ​​module with the at least one set of training EEG data until the performance of the AI ​​module meets predetermined performance conditions; and (iii) deploying the AI ​​module to perform steps (c) and / or (d).

[0058] In some embodiments, the method further includes the following steps: (g) obtaining at least one heart rate data of the subject by a heart rate sensor module.

[0059] In some embodiments, step (f) further includes the following steps: (f1) stimulating the target brain region of the subject with a current of about 1.5 mA to about 2 mA by the at least one tDCS module. definition

[0060] As used herein and in the claims, the terms “comprising” (or any related form such as “comprise” and “comprises”), “including” (or any related form such as “include” or “includes”), “containing” (or any related form such as “contain” or “contains”) mean to include the following elements, but do not exclude other elements. It should be understood that for each embodiment in which the terms “comprising” (or any related form such as “comprise” and “comprises”), “including” (or any related form such as “include” or “includes”), or “containing” (or any related form such as “contain” or “contains”) are used, this disclosure / application also includes alternative embodiments in which the terms “comprising”, “including”, or “contains” are replaced with “consistently consisting of” or “consisting of”. These alternative embodiments using the terms "composed of" or "substantially composed of" are understood to be smaller-scale embodiments that "comprise", "include", or "contain" the embodiments.

[0061] For clarity, “comprising,” “including,” “containing,” and “having,” as well as any related forms, are open-ended terms that allow for additional elements or features beyond the specified essential elements, while “consisting of” is a closed-ended term that limits the elements listed in the claims and excludes any elements, steps, or ingredients not specified in the claims.

[0062] As used herein, the singular forms “a / an” and “the” are intended to also include the plural forms unless the context clearly indicates otherwise. When a range is mentioned in the specification, the range is understood to include every discrete point within the range. For example, 1-7 means 1, 2, 3, 4, 5, 6, and 7.

[0063] As used herein and in the claims, the term “about” is understood to be within the normal tolerance range in the art and not exceeding ±10% of the specified value. For example only, about 50 means from 45 to 55, including all values ​​in between. As used herein, the phrase “about” also includes the specific value; for example, “about 50” includes 50.

[0064] As used herein and in the claims, the terms “substantially”, “largely”, “essentially”, or “basically” mean that it is not necessary to exactly achieve the listed features, angles, shapes, states, structures, or values, but deviations or variations (including, for example, tolerances, measurement errors, measurement accuracy limitations, and other factors known to those skilled in the art) may occur in an amount that does not preclude the effects that the features are expected to provide. For example, an object having a “substantially” cylindrical shape means that the object has a precisely cylindrical shape or a nearly precisely cylindrical shape. In another example, an object “substantially” perpendicular to a surface means that the object is precisely perpendicular to the surface or nearly precisely perpendicular to the surface, for example, with a deviation of 5%.

[0065] It should be understood that terms such as “top,” “bottom,” “middle,” “side,” “length,” “inner,” “outer,” “internal,” “external,” “outer,” “vertical,” and “horizontal,” which may be used herein, describe reference points only and do not limit the invention to any particular orientation or configuration. Furthermore, terms such as “first,” “second,” and “third” identify only one of the various parts, components, and / or reference points disclosed herein, and similarly do not limit the invention to any particular configuration or orientation.

[0066] As used herein and in the claims, unless otherwise stated, “coupled” or “connected” means directly or indirectly electrically coupled or connected via one or more electrical devices.

[0067] As used herein and in the claims, “electroencephalography” or “EEG” refers to a non-invasive neurophysiological monitoring technique that records electrical activity of the brain using electrodes placed on the scalp of a subject.

[0068] As used herein and in the claims, “transcranial direct current stimulation” or “tDCS” refers to a non-invasive neuromodulation technique that delivers a low-intensity constant current through electrodes placed on the scalp of a subject to modulate the excitability of neurons in a target brain region.

[0069] As used herein and in the claims, “cognitive impairment” or “COI” means a decline or impairment in one or more cognitive domains (including memory, attention, executive function, language, visuospatial skills, and processing speed) that may interfere with an individual’s ability to perform daily activities.

[0070] As used herein and in the claims, “operationally connected” or “operationally connected” refers to a connection between two or more components that enables these components to function together in a intended manner, including but not limited to the transmission of data, signals, or power between the components. In some examples, an operational connection is achieved through direct physical contact, an indirect connection via one or more intermediate components, or a wired or wireless communication path.

[0071] As used herein and in the claims, “electrical connection” means a connection between two or more components through which electrical signals, electrical power, or both can be transmitted. In some examples, the components in an electrical connection are directly connected or indirectly connected via one or more intermediate electrical conductors, circuits, or components.

[0072] As used herein and in the claims, "wireless communication" refers to a connection between two or more components or devices that enables the transmission of data or signals without the use of a physical wired connection. In some examples, wireless communication is achieved through radio frequency technologies such as Bluetooth, Wi-Fi, cellular networks, or other electromagnetic transmission methods.

[0073] As used herein and in the claims, "subject" means an animal, such as a mammal, including but not limited to primates (e.g., humans), cattle, sheep, goats, horses, dogs, cats, rabbits, rats, mice, etc. In some instances, "subject" refers to a human.

[0074] As used herein and in the claims, "wearable device" means a device configured to be worn on a subject. In this example, the wearable device is worn on the subject's head for the purpose of assessing and / or modulating neurological conditions, and the wearable device includes at least a head-mounted device frame, an EEG module, and a tDCS module.

[0075] As used herein and in the claims, “system” means an integrated arrangement of components including at least one wearable device, at least one terminal, and optionally at least one remote server, configured to work together to assess and / or modulate a subject’s neurological condition.

[0076] As used herein and in the claims, "method" refers to a series of steps or procedures performed using a wearable device or system as described herein for assessing and / or modulating a subject's neurological condition.

[0077] As used herein and in the claims, “neuropathy” means an impairment or dysfunction affecting the brain or nervous system, including but not limited to cognitive impairment, anxiety disorders, depression and attention deficit hyperactivity disorder.

[0078] As used herein and in the claims, “anxiety disorder” refers to a neurological or psychological condition characterized by excessive worry, tension, or unease, which can be assessed and / or managed using the devices, systems, and methods described herein.

[0079] As used herein and in the claims, “depression” refers to a mood disorder characterized by persistent feelings of sadness, loss of interest or other emotional and cognitive symptoms, which can be assessed and / or modulated using the devices, systems and methods described herein.

[0080] As used herein and in the claims, “attention deficit hyperactivity disorder” or “ADHD” refers to a neurodevelopmental disorder characterized by symptoms of inattention, hyperactivity, and impulsivity, which can be assessed and / or modulated using the devices, systems, and methods described herein.

[0081] As used herein and in the claims, “head-mounted device frame” refers to a structural housing or arcuate frame whose size and shape are set to conform to the contours of the subject’s head and configured to support and hold the EEG module, tDCS module and other components of the wearable device.

[0082] As used herein and in the claims, “EEG module” refers to a component of a wearable device that includes at least one EEG electrode and is configured to obtain at least one set of EEG data from a subject, and may further include a signal amplifier, a digitizer, and a microcontroller for data processing.

[0083] As used herein and in the claims, “one EEG electrode” or “multiple EEG electrodes” means one or more sensors configured to be placed on or near the scalp of a subject to detect and record electrical activity in the brain.

[0084] As used herein and in the claims, “EEG data” refers to electrical signals or information recorded from the brain of a subject via EEG electrodes, which may include measurements of absolute spectral power in a specific frequency band and may be used to assess neurological disorders.

[0085] As used herein and in the claims, “tDCS module” refers to a component of a wearable device that includes at least one tDCS electrode and is configured to deliver transcranial direct current stimulation to at least one target brain region of a subject, and may further include control and safety circuitry.

[0086] As used herein and in the claims, “one tDCS electrode” or “multiple tDCS electrodes” means one or more electrodes configured to deliver a low-intensity current to the scalp of a subject to stimulate a target brain region, and may include at least one anode and one cathode.

[0087] As used herein and in the claims, “target brain region” means a specific brain region intended to be monitored by EEG electrodes and / or stimulated by tDCS electrodes, such as the dorsolateral prefrontal cortex or other regions labeled according to the International 10-20 system.

[0088] As used herein and in the claims, "first region" refers to the region on the subject's head where the EEG electrodes are located when the wearable device is worn, which may include the T4 region, the FP1 region, and / or the FP2 region.

[0089] As used herein and in the claims, "first target area" refers to the area of ​​a subject's head where EEG electrodes are positioned in the vicinity or in contact with the head-mounted device frame to obtain EEG data.

[0090] As used herein and in the claims, the “second target area” refers to the area of ​​the subject’s head where the tDCS electrode is positioned in the vicinity or in contact with the head-mounted device frame to deliver transcranial direct current stimulation.

[0091] As used herein and in the claims, “T4 region” refers to the scalp location corresponding to the right temporal lobe region of the brain according to the international 10-20 electrode placement system.

[0092] As used herein and in the claims, “FP1 area” refers to the scalp location corresponding to the left frontal pole region of the brain according to the international 10-20 electrode placement system.

[0093] As used herein and in the claims, “FP2 area” refers to the scalp location corresponding to the right frontal pole region of the brain according to the international 10-20 electrode placement system.

[0094] As used herein and in the claims, “F3 region” refers to the scalp location corresponding to the left frontal lobe region of the brain according to the international 10-20 electrode placement system.

[0095] As used herein and in the claims, “F4 zone” refers to the scalp location corresponding to the right frontal lobe region of the brain according to the international 10-20 electrode placement system.

[0096] As used herein and in the claims, "headband" refers to a component of a head-mounted device frame that includes a central portion, a first arm portion, and a second arm portion, the size and shape of which are configured to span at least a portion of the subject's head.

[0097] As used herein and in the claims, “central portion” means the portion of the headband that is configured to rest on or near the forehead or top of the subject’s head and is configured to hold the EEG electrodes.

[0098] As used herein and in the claims, "first arm portion" refers to the portion of the headband that extends from a first side of the central portion and is configured to extend rearward along one side of the subject's head.

[0099] As used herein and in the claims, "second arm portion" refers to the portion of the headband that extends from the central portion to the second side opposite to the first side and is configured to extend rearward along the opposite side of the subject's head.

[0100] As used herein and in the claims, “tDCS electrode holder” refers to a component of a head-mounted device frame configured to hold and support tDCS electrodes, and may include lateral electrode holder portions and neck portions.

[0101] As used herein and in the claims, “lateral electrode holding portion” refers to a portion of the tDCS electrode holder that extends laterally and is configured to hold the tDCS electrode at or near each of its two ends.

[0102] As used herein and in the claims, "neck portion" refers to the portion of the tDCS electrode holder that connects the central portion to the lateral electrode holder portion and is configured to switch between at least a retracted position and an extended position.

[0103] As used herein and in the claims, “retracted position” refers to a configuration of the neck portion in which the neck portion is shortened or retracted, thereby allowing the tDCS electrode to be positioned closer to the central portion of the head-mounted device frame.

[0104] As used herein and in the claims, “extended position” refers to a configuration of the neck portion in which the neck portion is extended or expanded, thereby allowing the tDCS electrodes to be positioned further away from the central portion of the head-mounted device frame to accommodate different head sizes and shapes.

[0105] As used herein and in the claims, a “flexible EEG support band” refers to a component made of a flexible material (such as silicone) that extends from or is attached to the inner surface of a central portion and is configured to hold the EEG electrodes while conforming to the contours of the subject’s head.

[0106] As used herein and in the claims, a “wireless communication module” refers to a component of a wearable device configured to wirelessly transmit and receive data (including EEG data and tDCS schemes) to and from at least one terminal and / or at least one remote server, and may include Wi-Fi and / or Bluetooth capabilities.

[0107] As used herein and in the claims, "terminal" means a device that is communicatively connected to a wearable device, configured to serve as a user interface for controlling the wearable device and for receiving, sending and / or displaying data, and may include a smartphone, tablet, personal computer and / or dedicated remote control.

[0108] As used herein and in the claims, "remote server" means a computing device or platform located remotely from the wearable device and configured to receive EEG data, perform analysis, generate evaluations and / or tDCS schemes, and transmit data to the wearable device and / or terminal.

[0109] As used herein and in the claims, a “cloud-based platform” refers to a remote server that provides computing services over a network and is configured to wirelessly communicate with wearable devices and / or terminals for data storage, processing, and transmission.

[0110] As used herein and in the claims, "processing unit" refers to a component configured to analyze EEG data, determine a tDCS scheme, and control the operation of a wearable device, and may include a microprocessor or microcontroller unit.

[0111] As used herein and in the claims, a “communication connection” means a link between two or more components or devices that enables the transmission of data, signals or control commands, which may be achieved by wired or wireless means.

[0112] As used herein and in the claims, “evaluation” means the assessment or determination of a subject’s neurological condition based on the analysis of EEG data and / or other data obtained from the subject.

[0113] As used herein and in the claims, a “tDCS protocol” refers to a set of parameters or instructions for delivering transcranial direct current stimulation to a subject, which can be customized based on an assessment of the subject’s neurological condition and may include parameters such as current intensity, duration, and target brain region.

[0114] As used herein and in the claims, "heart rate sensor module" refers to a component of a wearable device configured to measure and acquire at least one set of heart rate data of a subject.

[0115] As used herein and in the claims, “heart rate data” refers to information relating to the subject’s heart rate obtained by the heart rate sensor module.

[0116] As used herein and in the claims, a “rechargeable battery” means a power source configured to store electrical energy and provide power to components of a wearable device and capable of being recharged via a charging interface.

[0117] As used herein and in the claims, "battery charging port" means an interface on a wearable device configured to receive external power to charge a rechargeable battery, and may include a Type-C port or a magnetic charging port.

[0118] As used herein and in the claims, "wearing status module" refers to a component of a wearable device configured to determine whether the wearable device is being worn by a subject (including detecting whether it is on the head or off the head).

[0119] As used herein and in the claims, “wearing state” refers to the state of a wearable device as to whether it is being worn by a subject, including a state on the head and a state outside the head.

[0120] As used herein and in the claims, “on-head state” means a wearing state indicating that the wearable device is positioned on the head of the subject and worn by the subject.

[0121] As used herein and in the claims, “outside-the-head state” means a wearing state in which the wearable device is not positioned on the subject’s head or not worn by the subject.

[0122] As used herein and in the claims, "infrared sensor" refers to a sensor configured to detect infrared radiation, which can be used in the wear status module to determine whether the wearable device is being worn by the subject.

[0123] As used herein and in the claims, “a conductive silicone electrode” or “a plurality of conductive silicone electrodes” means one or more electrodes made of conductive silicone material configured to deliver current to the scalp of a subject for tDCS stimulation.

[0124] As used herein and in the claims, "comb configuration" refers to an arrangement of a plurality of conductive silicone electrodes arranged in a pattern similar to comb teeth and configured to facilitate contact with the scalp through the hair.

[0125] As used herein and in the claims, "brush configuration" refers to an arrangement of a plurality of conductive silicone electrodes arranged in a pattern similar to brush bristles and configured to facilitate contact with the scalp through the hair.

[0126] As used herein and in the claims, “slidably movable” refers to a configuration in which a component (such as a tDCS electrode or tDCS electrode socket) is movable relative to another component (such as a lateral electrode holder) along a slide or guide rail to allow for position adjustment.

[0127] Numbered Examples

[0128] Group 1

[0129] Example 1. A wearable device for assessing and modulating neurological disorders in a subject, the wearable device comprising: (a) a head-mounted device frame; (b) at least one electroencephalogram (EEG) module; (c) at least one transcranial direct current stimulation (tDCS) module; and (d) a wireless communication module for communicating with a remote server, wherein the at least one EEG module, the at least one tDCS module, and the wireless communication module are disposed on or housed within the head-mounted device frame and are communicatively connected to each other, wherein the at least one EEG module is configured to acquire at least one set of EEG data from the subject wearing the wearable device, wherein the wireless communication module is configured to transmit the at least one set of EEG data to the remote server for analysis and to receive a tDCS protocol from the remote server, wherein the tDCS protocol is determined based on the analysis of the at least one set of EEG data, and wherein the at least one tDCS module is configured to stimulate at least one target brain region of the subject wearing the wearable device according to the tDCS protocol.

[0130] Example 2. The wearable device as described in Example 1, wherein the at least one tDCS module includes a plurality of tDCS electrodes, each tDCS electrode being configured to stimulate at least a portion of the target brain region of the subject with a current of about 1.5 mA to about 2 mA.

[0131] Example 3. A wearable device as described in any of the preceding embodiments, wherein the size and shape of the head-mounted device frame are configured to substantially conform to the contour of the subject's head portion, and wherein the head-mounted device frame further comprises: a central portion, the size and shape of which are configured to rest on at least a portion of the subject's head, the central portion including a first side and a second side opposite to the first side; a first arm portion extending from the first side, the first arm portion including a first arm proximal portion and a first arm bend portion, the size and shape of which are configured to substantially conform to the shape of the subject's right ear; and a second arm portion extending from the second side, the second arm portion including a second arm proximal portion and a second arm bend portion, the size and shape of which are configured to substantially conform to the shape of the subject's left ear.

[0132] Example 4. The wearable device as described in Example 3, wherein the at least one tDCS module includes a plurality of tDCS electrodes disposed on the inner side of the proximal portion of the second arm, such that when the subject wears the wearable device, the plurality of tDCS electrodes are located near the F3 region of the subject's brain.

[0133] Example 5. The wearable device as described in Example 3, wherein the at least one EEG module includes a plurality of EEG electrodes disposed on the inner side of the first bent portion of the arm, such that when the subject wears the wearable device, the plurality of EEG electrodes are located near the T4 region of the subject's brain.

[0134] Example 6. A wearable device as described in any of the preceding examples, wherein the neurological condition includes cognitive impairment (COI), anxiety disorder, depression, and / or attention deficit hyperactivity disorder (ADHD).

[0135] Example 7. The wearable device as described in any of the preceding embodiments further includes a processing unit configured to analyze the at least one set of EEG data and determine the tDCS scheme.

[0136] Example 8. The wearable device as described in any of the preceding embodiments further includes a heart rate sensor module configured to acquire at least one set of heart rate data of the subject.

[0137] Example 9. The wearable device as described in any of the preceding examples further includes a rechargeable battery and optionally a battery charging port.

[0138] Example 10. The wearable device as described in any of the preceding embodiments further includes a wearing status module, the wearing status module being configured to determine the wearing status of the wearable device, wherein the wearing status includes a head-on state and an off-head state of the subject.

[0139] Example 11. The wearable device as described in Example 10, wherein the wearing status module includes an infrared sensor.

[0140] Example 12. A wearable device for assessing and modulating neurological disorders in a subject, the wearable device comprising: a head-mounted frame; at least one electroencephalogram (EEG) module; at least one transcranial direct current stimulation (tDCS) module; and a wireless communication module for communicating with a remote server, wherein the at least one EEG module, the at least one tDCS module, and the wireless communication module are disposed on or housed within the head-mounted frame and are communicatively connected to each other, wherein the at least one EEG module is configured to acquire at least one set of EEG data from the subject wearing the wearable device, wherein the wireless communication module is configured to transmit the at least one set of EEG data to the remote server for analysis and to receive a tDCS protocol from the remote server, wherein the tDCS protocol is determined based on the analysis of the at least one set of EEG data, wherein the at least one tDCS module is configured to stimulate at least one target brain region of the subject wearing the wearable device according to the tDCS protocol, wherein the at least one tDCS module includes a plurality of tDCS electrodes, each tDCS electrode being configured to use an amplitude of approximately 1.A current of 5 mA to approximately 2 mA is used to stimulate at least a portion of the target brain region of the subject, wherein the size and shape of the head-mounted device frame are configured to substantially conform to the contour of the subject's head portion, wherein the head-mounted device frame further includes: a central portion, the size and shape of which are configured to rest on at least a portion of the top of the subject's head, the central portion including a first side and a second side opposite to the first side; a first arm portion extending from the first side, the first arm portion including a first proximal arm portion and a first flexed arm portion, the size and shape of which are configured to substantially conform to the shape of the subject's right ear; and a second arm portion extending from the second side, the second arm portion including a second proximal arm portion and a second flexed arm portion, the size and shape of which are configured to substantially conform to the shape of the subject's left ear, wherein the at least one tDCS module includes a plurality of tDCS electrodes disposed on the inner side of the second arm proximal portion, such that when the subject wears the wearable device, the plurality of tDCS electrodes are located in the... The wearable device is located near the F3 region of the subject's brain. The at least one EEG module includes multiple EEG electrodes disposed on the inner side of the bent portion of the first arm, such that when the subject wears the wearable device, the multiple EEG electrodes are located near the T4 region of the subject's brain. The neurological conditions include cognitive impairment (COI), anxiety disorder, depression, and / or attention deficit hyperactivity disorder (ADHD). The wearable device further includes a processing unit configured to analyze the at least one set of EEG data and determine the tDCS protocol. The wearable device further includes a heart rate sensor module configured to acquire at least one set of heart rate data from the subject. The wearable device further includes a rechargeable battery and optionally a battery charging port. The wearable device further includes a wearing status module configured to determine the wearing status of the wearable device, including a head-on state and an off-head state. The wearing status module includes an infrared sensor.

[0141] Example 13. A system for assessing and modulating neurological disorders in a subject, the system comprising: (a) at least one wearable device as described in any of the preceding embodiments; (b) a server communicatively connected to the at least one wearable device via the wireless communication module, the server comprising: an artificial intelligence (AI) module configured to: (i) analyze at least one set of EEG data obtained from at least one EEG module of each wearable device to generate at least one assessment of neurological disorders in the subject wearing the wearable device; and (ii) generate a tDCS protocol based on the at least one assessment, such that the tDCS protocol is tailored to the neurological disorders of the subject; wherein the server is configured to transmit the tDCS protocol to the wearable device, and the at least one tDCS module is configured to stimulate the target brain region of the subject according to the tDCS protocol.

[0142] Example 14. The system as described in Example 13, wherein the server is a cloud-based platform wirelessly connected to the at least one wearable device via the wireless communication module.

[0143] Example 15. The system as described in any of the preceding examples, wherein the neurological condition includes cognitive impairment (COI), anxiety disorder, depression, and / or attention deficit hyperactivity disorder (ADHD).

[0144] Example 16. A method for assessing and modulating a subject's neurological condition using a system as described in any of the preceding embodiments, the method comprising the steps of: (a) obtaining at least one set of EEG data of the subject wearing the wearable device by the at least one EEG module; (b) transmitting the at least one set of EEG data to the server by the wireless communication module of the wearable device; (c) analyzing the at least one set of EEG data by the AI ​​module to generate at least one assessment of the subject's neurological condition; (d) generating the tDCS protocol by the AI ​​module based on the at least one assessment, such that the tDCS protocol is customized according to the subject's neurological condition; (e) transmitting the tDCS protocol to the wireless communication module of the wearable device by the server; and (f) executing the tDCS protocol by the at least one tDCS module to stimulate the target brain region of the subject.

[0145] Example 17. The method as described in Example 16, prior to step (a), further includes the following steps: (i) obtaining at least one set of training EEG data from a reference data source labeled by a set of neurological symptoms and / or a set of tDCS schemes; (ii) training the AI ​​module with the at least one set of training EEG data until the performance of the AI ​​module meets predetermined performance conditions; and (iii) deploying the AI ​​module to perform steps (c) and / or (d).

[0146] Example 18. The method as described in any of the preceding examples further includes the following steps: (g) obtaining at least one heart rate data of the subject by the heart rate sensor module.

[0147] Example 19. The method as described in any of the preceding examples, wherein step (f) further comprises the following steps: (f1) stimulating the target brain region of the subject with a current of about 1.5 mA to about 2 mA by the at least one tDCS module.

[0148] Group 2

[0149] Example 1. A wearable device for assessing and / or modulating neurological disorders in a subject, the wearable device comprising: (a) a headband frame; (b) an electroencephalography (EEG) module including at least one EEG electrode; and (c) a transcranial direct current stimulation (tDCS) module including at least one tDCS electrode, wherein the EEG module is configured to acquire at least one set of EEG data from the subject; wherein the tDCS module is configured to stimulate at least one target brain region of the subject; and wherein the headband frame further comprises: (a1) a headband including a central portion, a first arm portion, and a second arm portion, the size and shape of the headband being configured to at least span a first region of the subject's head, wherein the central portion is configured to hold the at least one EEG electrode; (a2) A tDCS electrode holder is configured to hold at least one tDCS electrode, wherein, when the head-mounted device frame is worn on the subject's head, the at least one EEG electrode is positioned near or in contact with a first target area, and the at least one tDCS electrode is positioned to or in contact with a second target area on the subject's head.

[0150] Example 2. The wearable device as described in Example 1, wherein the first region is or includes the T4 region, the FP1 region and / or the FP2 region; and / or the second region is or includes the F3 region and / or the F4 region.

[0151] Example 3. The wearable device as described in Example 1, wherein the tDCS electrode holder includes a lateral electrode holder portion and a neck portion; wherein the neck portion is integral with or attached to the central portion on the lower side, and integral with or attached to the lateral electrode holder portion on the upper side; and wherein the neck portion is configured to be switchable at least between a retracted position and an extended position.

[0152] Example 4. The wearable device as described in Example 1 further includes a wireless communication module for communicating with at least one terminal and / or at least one remote server.

[0153] Example 5. The wearable device as described in Example 4, wherein the wireless communication module is configured to transmit the at least one set of EEG data to the at least one terminal and / or the at least one remote server for analysis, and is configured to receive a tDCS scheme from the at least one terminal and / or the at least one remote server; and wherein the tDCS scheme is determined based on the analysis of the at least one set of EEG data.

[0154] Example 6. The wearable device as described in Example 5, wherein the at least one tDCS module is configured to stimulate the at least one target brain region of the subject wearing the wearable device according to the tDCS protocol.

[0155] Example 7. The wearable device as described in Example 1 further includes a flexible EEG support band that extends from or is attached to the inner surface of the central portion, and wherein the at least one EEG electrode includes three EEG electrodes positioned on the EEG support band.

[0156] Example 8. The wearable device as described in Example 3, wherein the at least one tDCS electrode comprises two TDCS electrodes positioned at or near both ends of the lateral electrode holding portion.

[0157] Example 9. The wearable device as described in Example 1, wherein each of the tDCS electrodes includes a plurality of conductive silicone electrodes arranged to form a comb-like or brush-like configuration.

[0158] Example 10. A wearable device as described in Example 3, wherein the at least one tDCS electrode is configured to be slidably movable relative to the lateral electrode holding portion.

[0159] Example 11. The wearable device as described in Example 1, wherein the at least one tDCS module includes a plurality of tDCS electrodes, each tDCS electrode being configured to stimulate at least a portion of the target brain region of the subject with a current of about 1.5 mA to about 2 mA.

[0160] Example 12. The wearable device as described in Example 1, wherein the neurological condition includes cognitive impairment (COI), anxiety disorder, depression, and / or attention deficit hyperactivity disorder (ADHD).

[0161] Example 13. The wearable device as described in Example 5 further includes a processing unit configured to analyze the at least one set of EEG data and determine the tDCS scheme.

[0162] Example 14. The wearable device as described in Example 1 further includes a heart rate sensor module configured to acquire at least one set of heart rate data of the subject.

[0163] Example 15. The wearable device as described in Example 1 further includes a rechargeable battery and a battery charging port optionally electrically connected to the EEG module and the tDCS module.

[0164] Example 16. The wearable device as described in Example 1 further includes a wearing state module, the wearing state module being configured to determine the wearing state of the wearable device, wherein the wearing state includes the subject's on-head state and off-head state.

[0165] Example 17. The wearable device as described in Example 16, wherein the wearing status module includes an infrared sensor.

[0166] Example 18. A wearable device for assessing and / or modulating neurological disorders in a subject, the wearable device comprising: (a) a head-mounted device frame; (b) an electroencephalogram (EEG) module including two EEG electrodes; and (c) a transcranial direct current stimulation (tDCS) module including three tDCS electrodes; (d) a wireless communication module for communicating with at least one terminal and optionally at least one remote server; (f) a rechargeable battery and a battery charging port optionally electrically connected to the EEG module and the tDCS module; and (h) A processing unit configured to analyze the at least one set of EEG data and determine a tDCS protocol, wherein the EEG module is configured to acquire at least one set of EEG data from the subject; wherein the tDCS module is configured to stimulate at least one target brain region of the subject; wherein the wireless communication module is configured to transmit the at least one set of EEG data to a terminal or a remote server for analysis, and is configured to receive the tDCS protocol from the terminal or the remote server; and wherein the head-mounted device frame further includes: (a1) a headband comprising a central portion, a first arm portion, an opposite second arm portion, and a flexible EEG support band extending from or attached to the inner surface of the central portion, and the three EEG electrodes being positioned on the EEG support band, the size and shape of the headband being set to at least span the T4 and / or FP1 regions of the subject's head, wherein the central portion is configured to hold the three EEG electrodes; (a2) A tDCS electrode holder, comprising a lateral electrode holding portion and a neck portion, is configured to hold two tDCS electrodes. The neck portion is integral with or attached to the central portion on its lower side, and integral with or attached to the lateral electrode holding portion on its upper side. The neck portion is configured to be switchable at least between a retracted position and an extended position. When the head-mounted device frame is worn on the subject's head, at least one EEG electrode is... The at least one tDCS electrode is positioned near or in contact with the FP1 and / or FP2 regions of the subject's head, and is positioned in or in contact with the F3 and / or F4 regions of the subject's head; wherein each of the tDCS electrodes includes a plurality of conductive silicone electrodes arranged to form a comb or brush configuration, each of the two tDCS electrodes includes a plurality of conductive silicone electrodes arranged to form a comb or brush configuration, and the two tDCS electrodes are positioned at or near both ends of the lateral electrode holding portion and are slidably movable relative to the lateral electrode holding portion;Furthermore, the tDCS protocol is determined based on the analysis of the at least one set of EEG data, and the at least one tDCS module is configured to stimulate at least one target brain region of the subject wearing the wearable device according to the tDCS protocol, and each comb-shaped or brush-shaped conductive silicone electrode is configured to stimulate at least a portion of the target brain region of the subject with a current of approximately 1.5 mA to approximately 2 mA.

[0167] Example 19. A system for assessing and / or modulating neurological disorders in a subject, the system comprising: (a) at least one wearable device as described in Example 1; (b) at least one terminal; and (c) optionally, at least one remote server, wherein the at least one terminal and optionally the at least one remote server are communicatively connected to each of the at least one wearable device, wherein the system is configured to: (i) analyze at least one set of EEG data obtained from the EEG module of the wearable device to generate at least one assessment of neurological disorders in the subject wearing the wearable device; and / or (ii) generate a tDCS protocol based on the at least one assessment, such that the tDCS protocol is tailored to the neurological disorders of the subject, wherein the tDCS module is configured to stimulate at least one target brain region of the subject according to the tDCS protocol.

[0168] Example 20. The system as described in Example 19, wherein each of the remote servers is a cloud-based platform that wirelessly communicates with the at least one wearable device and / or the at least one terminal.

[0169] Example 21. The system as described in Example 19, wherein the neurological condition includes cognitive impairment (COI), anxiety disorder, depression, and / or attention deficit hyperactivity disorder (ADHD).

[0170] Example 22. A method for assessing and / or modulating a neurological condition in a subject, the method comprising the steps of: (a) obtaining at least one set of EEG data of a subject wearing a wearable device as described in any one of Examples 1 to 18 by at least one EEG module; (b) optionally, transmitting the at least one set of EEG data to a terminal or a remote server by a wireless communication module of the wearable device; (c) analyzing the at least one set of EEG data by the at least one wearable device, the at least one terminal, and / or the at least one remote server to generate at least one assessment of the neurological condition in the subject; (d) generating a tDCS protocol based on the at least one assessment by the at least one wearable device, the at least one terminal, and / or the at least one remote server, such that the tDCS protocol is customized according to the neurological condition in the subject; (e) optionally, transmitting the tDCS protocol to the wireless communication module of the wearable device by the at least one terminal and / or the at least one remote server; and (f) executing the tDCS protocol by the tDCS module to stimulate at least one target brain region of the subject.

[0171] Example 23. The method as described in Example 22 further includes the following steps: (g) obtaining at least one heart rate data of the subject by the heart rate sensor module.

[0172] Example 24. The method as described in Example 22, wherein step (f) further comprises the following steps: (f1) stimulating the at least one target brain region of the subject with a current of about 1.5 mA to about 2 mA by the at least one tDCS module. Example

[0173] The following example embodiments can be practiced individually or in combination to provide devices, systems, and methods for comprehensive AI-based diagnostic and therapeutic interventions for cognitive and neurophysiological disorders. Example 1 1. Equipment

[0174] Now for reference Figures 1A to 1DAn example embodiment of a wearable device 1000 for assessing and modulating neurological conditions in a subject is shown. In this example, the wearable device 1000 includes a head-mounted device frame 1100, an electroencephalogram (EEG) module 1200, a transcranial direct current stimulation (tDCS) module 1300, and a wireless communication module 1400. The EEG module 1200, the tDCS module 1300, and the wireless communication module 1400 are disposed on or housed within the head-mounted device frame 1100 and are communicatively connected to each other. The EEG module 1200 is configured to provide the wearer with the device's... Figures 1A to 1D EEG data (not shown). The tDCS module 1300 is configured to stimulate at least one target brain region of a subject wearing the device 1000 according to a tDCS protocol determined based on the analysis of at least one set of EEG data.

[0175] Now for reference Figure 1A The image shows a top view of the wearable device 1000. In this embodiment, the headband frame 1100 is a headband-shaped shell or curved frame whose shape and size are configured to conform to the contours of a subject's head, extending from one side of the head to the other in a manner similar to a headband. The headband frame 1100 is curved and configured to rest over or along the top of the head, thereby providing stable physical contact with the scalp when worn by the subject. The headband frame 1100 includes a central portion 1110 (the shape and size of which are configured to rest on the top of the subject's head), a first arm portion 1120 extending rearward from a first side (hereinafter, the right side) of the central portion 1110, and a second arm portion 1130 extending rearward from a second side (hereinafter, the left side) opposite to the first side of the central portion 1110. The headband frame design allows for a secure attachment of the wearable device to comfortably fit the subject's head size.

[0176] Now for reference Figure 1BA perspective view of device 1000 is shown. The first arm portion 1120 includes a distal first arm portion 1121, a bent first arm portion 1122, an elongated first arm portion 1123, and a proximal first arm portion 1124. The proximal first arm portion 1124 connects the right side of the central portion 1110 of the head-mounted device to the first arm portion 1120. The elongated first arm portion 1123 extends rearward from the proximal first arm portion 1124 toward the distal first arm portion 1121, thereby bending downward at the bent first arm portion 1122 located near the distal first arm portion 1121. The shape of the bent first arm portion 1122 is configured to conform to the shape of the subject's right ear for a comfortable fit. Symmetrically, the second arm portion 1130 includes a distal second arm portion 1131, a bent second arm portion 1132, an elongated second arm portion 1133, and a proximal second arm portion 1134, and its shape and structure are similar to those of the first arm portion 1120. The proximal portion 1134 of the second arm connects to the left side of the central portion 1110 of the head-mounted device. The elongated portion 1133 of the second arm extends rearward from the proximal portion 1134 toward the distal portion 1131, bending downward at a curved portion 1132 located near the distal portion 1131. The curved portion 1132 is shaped to conform to the subject's left ear for a comfortable fit.

[0177] In this embodiment, the tDCS module 1300 is housed within the head-mounted device frame 1100 near the proximal portion 1134 of the second arm, wherein tDCS electrodes (not shown) are disposed on the inner surface of the head-mounted device frame 1100 near the proximal portion 1134 of the second arm, allowing the tDCS electrodes to effectively contact the scalp of the subject wearing the wearable device 1000. In some embodiments, each tDCS electrode has a diameter of 5 mm or less. The EEG module 1200 is housed within the head-mounted device frame 1100 near the bend portion 1122 of the first arm, wherein EEG electrodes (not shown) are disposed on the inner surface of the head-mounted device frame 1100 near the bend portion 1122 of the first arm, allowing the EEG electrodes to effectively contact the scalp of the subject wearing the wearable device 1000. In some embodiments, each EEG electrode has a diameter of 5 mm or less.

[0178] In some embodiments, a battery charging port 1500 is disposed on the distal portion 1121 of the first arm. In some embodiments, a power switch and / or an LED indicator displaying the battery status of the wearable device 1000 are disposed on the first arm portion 1120 or the second arm portion 1130.

[0179] In some embodiments, the size and shape of the plurality of tDCS electrodes are configured as a tDCS electrode array. In some embodiments, the size and shape of the plurality of EEG electrodes are configured as an EEG electrode array.

[0180] Now for reference Figure 1C The image shows a front view of device 1000. Wireless communication module 1400 is housed within central portion 1110. In some embodiments, central portion 1110 may also house one or more power cables and / or signal cables.

[0181] Now for reference Figures 1B to 1D Multiple batteries are housed within the first elongated arm portion 1123, the second elongated arm portion 1133, and / or the central portion 1110. In some embodiments, the batteries are rechargeable batteries. In some embodiments, the batteries are generally rectangular in shape and have a thickness of approximately 4 mm.

[0182] In some examples, the head-mounted device is a wearable device. The EEG module (also known as an EEG sensor) is a wireless hybrid EEG unit configured to collect EEG signals at a target brain region. tDCS electrodes are configured to deliver tDCS current to said region.

[0183] In some examples, the device may further include a heart rate sensor module for measuring heart rate to obtain heart rate data of the subject.

[0184] In some examples, the EEG sensor is configured to monitor the absolute spectral power of a specific frequency band. The tDCS electrode is configured to stimulate the target brain region with a specific current (e.g., 1.5 mA to 2 mA).

[0185] Now for reference Figures 2A to 2C The image shows the position of the wearable device 1000 when positioned on the head of the subject 200. The wearable device 1000 is configured to rest above or along the top of the head, thereby providing stable contact with the scalp. This configuration provides a stable and balanced placement of the wearable device 1000 on the subject's head, allowing the EEG electrodes of the EEG module 1200 and the tDCS electrodes of the tDCS module 1300 to effectively contact the target cranial region along the inner surface of the frame.

[0186] Let's refer to it together now. Figures 2A to 2C as well as Figure 3When the subject wears the wearable device 1000, the EEG electrodes of the EEG module 1200 are positioned to effectively contact a specific area on the scalp corresponding to the T4 region 320 of the brain, allowing the EEG module 1200 to record EEG data from the subject's T4 region 320. The tDCS electrodes of the tDCS module 1300 are positioned to effectively contact a specific area on the scalp corresponding to the F3 region 310 of the brain, allowing the tDCS module 1300 to stimulate the subject's F3 region 310.

[0187] In some examples, EEG sensors and / or tDCS electrodes are positioned to monitor and / or stimulate specific brain regions, such as the dorsolateral prefrontal cortex (DLPFC).

[0188] In some embodiments, the device is configured to perform the following steps: (i) quantifying the subject’s cognition using electroencephalography (EEG); (ii) identifying EEG biomarkers indicating cognitive impairment (COI); and (iii) applying a personalized transcranial direct current stimulation (tDCS) protocol targeting these EEG biomarkers. 2. System

[0189] In one example embodiment, the system is a closed-loop system, comprising: (i) A wearable device according to any of the embodiments described herein, the wearable device comprising a wireless hybrid EEG-tDCS electrode for simultaneous EEG recording and tDCS delivery; (ii) An AI-based data processing module connected to a head-mounted device and configured to detect EEG abnormalities and adjust treatment intensity in real time.

[0190] In some examples, the system includes a server configured (e.g., via one or more user terminals connected to the system) to securely share data with physicians regarding EEG biomarkers (also referred to in some embodiments as “a set of EEG data”) and treatment, thereby enabling remote monitoring. In some embodiments, the system can improve adherence to and efficacy of antidepressants, which are often hindered by poor working memory, by enhancing the cognitive performance of subjects suffering from depression.

[0191] In some examples, the system includes a server configured to perform workflow steps according to an AI algorithm. The AI ​​algorithm is configured to receive input data, analyze the data (e.g., for diagnostic purposes), and output expected data.

[0192] In some examples, the AI ​​model and / or related algorithms may include any kind of existing AI model. In some examples, the AI ​​model is trained using training data that is labeled during the labeling process.

[0193] In some examples, the system typically includes a cloud server and / or a clinician terminal for data storage, transmission, and display. In some examples, personalized / customized tDCS schemes are configured to be tailored using data from the cloud server and / or the clinician terminal (e.g., clinician feedback).

[0194] In some embodiments, the system includes an infrared lock housed within a wearable device, the infrared lock being configured to enhance subject compliance because clinicians can be aware of the identity of the subject using the wearable device.

[0195] In some examples, the system includes a database and software modules. The database is configured with a data infrastructure for collecting individual and population EEG biomarker data, thereby enabling the development of personalized / customized NIBS treatment plans. In some examples, the system includes a portal (e.g., a mobile app) configured to enable remote monitoring for subjects and physicians.

[0196] In some examples, the system includes a server configured to execute program instructions for an AI algorithm trained using public and / or proprietary data to interpret the collected EEG data and identify abnormalities that cause COI symptoms in the subject. The AI ​​algorithm forms a closed-loop system that adjusts treatment in real time based on EEG biomarkers. 3. Methods

[0197] In this example, a method is provided for assessing and modulating a subject's neurological condition using a system as described in any of the foregoing embodiments, the method comprising the following steps: (a) Obtaining at least one set of EEG data from a subject wearing a wearable device using at least one EEG module; (b) The wearable device's wireless communication module transmits at least one set of EEG data to the server; (c) The AI ​​module analyzes at least one set of EEG data to generate at least one assessment of the subject's neurological condition; (d) The AI ​​module generates a tDCS protocol based on at least one assessment, such that the tDCS protocol is customized according to the subject's neurological condition; (e) The server transmits the tDCS scheme to the wireless communication module of the wearable device; and (f) The tDCS protocol is executed by at least one tDCS module to stimulate the target brain region of the subject.

[0198] In some embodiments, prior to step (a), the method further includes the following steps: Obtain at least one set of training EEG data from a reference data source labeled by a set of neurological symptoms and / or a set of tDCS protocols; Train the AI ​​module using at least one set of training EEG data until the AI ​​module's performance meets predetermined performance conditions; and Deploy the AI ​​module to perform steps (c) and / or (d).

[0199] In some embodiments, the method further includes the step of obtaining at least one heart rate data of the subject from the heart rate sensor module.

[0200] In some embodiments, the method further includes stimulating a target brain region of the subject with a current of about 1.5 mA to about 2 mA by at least one tDCS module.

[0201] In some embodiments, the method further includes the step of obtaining at least one heart rate data of the subject from the heart rate sensor module.

[0202] In some embodiments, the method further includes the step of stimulating at least a portion of the subject's head region with a current of 1.5 mA to 2 mA by at least one tDCS module. Example 2.1

[0203] 4. Example wearable devices

[0204] Now for reference Figure 4 The diagram illustrates a schematic of an example wearable device 2000' for assessing and / or modulating neurological conditions in a subject. Device 2000' typically includes a head-mounted device frame 2100', an electroencephalogram (EEG) module 2200', and a transcranial direct current stimulation (tDCS) module 2300'. The EEG module 2200' includes multiple EEG electrodes (or EEG sensors) 2310', and the tDCS module includes multiple tDCS electrodes 2210'.

[0205] In some implementations, in addition to multiple EEG electrodes 2310', the EEF module typically includes a signal amplifier configured to amplify and filter the received signal, a digital converter for digitizing the regulated signal, and a microcontroller for data processing and output.

[0206] In some implementations, in addition to multiple tDCS electrodes 2210', the DCS module typically includes control and safety circuitry (such as a microcontroller for ramping and monitoring impedance, as well as automatic shutdown).

[0207] In one embodiment, the tDCS module 2300' includes two or more tDCS electrodes, including at least one anode and one cathode.

[0208] In one embodiment, device 2000' further includes a power supply (e.g., a battery) and / or processing units, which are electrically connected to each other and including EEG module 2200' and tDCS module 2300'.

[0209] In another embodiment, device 2000' does not include a power supply (e.g., a battery) or processing unit. Alternatively, device 2000' is electrically connected to an external power supply and / or an external processing unit. Example 2.2

[0210] 5. Example wearable devices

[0211] Now for reference Figure 5 This illustration shows a schematic diagram of another example wearable device 2000 for assessing and / or modulating neurological conditions in a subject. Device 2000 typically includes a head-mounted device frame 2100, an electroencephalogram (EEG) module 2200, and a transcranial direct current stimulation (tDCS) module 2300. The EEG module 2200 includes multiple EEG electrodes 2210, and the tDCS module includes multiple tDCS electrodes 2310. In this example, the EEG module 2200 includes three EEG electrodes 2210-1, 2210-2, and 2210-3 (collectively referred to as 2210), and the tDCS module includes two tDCS electrodes 2310-1 and 2310-2 (collectively referred to as 2310). The EEG module is configured to acquire at least one set of EEG data from the subject via the multiple EEG electrodes 2210. The tDCS module is configured to stimulate at least one target brain region of the subject. In this example, the at least one target brain region includes a second region of the subject's head.

[0212] In one embodiment, device 2000' further includes a power supply (e.g., a battery) and / or processing unit electrically connected to each other, as well as EEG module 2200' and tDCS module 2300.

[0213] In another embodiment, device 2000 does not include a power supply (e.g., a battery) or processing unit. Device 2000 is connected to an external power supply and / or an external processing unit.

[0214] The head-mounted device frame 2100 typically includes a headband 2110 and a tDCS electrode holder 2120. The headband 2110 and the tDCS electrode holder 2120 are separate pieces directly or indirectly connected (or attached) to each other, or they may form a single integral piece. In this example, the headband 2110 typically includes a central portion 2111, a first arm portion 2112, and a opposite second arm portion 2113. The central portion 2111, the first arm portion 2112, and the second arm portion 2113 can have any size and shape, provided that they together form a headband that can be worn by a subject's head, and that the central portion 2111 is located near a first zone. In this example, the central portion 2111, the first arm portion 2112, and the second arm portion 2113 together form a generally U-shaped headband. The first arm portion 2112 and the second arm portion 2113 are integral with, extend from, or attach to the central portion 2111 at two opposite ends of the central portion 2111. The headband 2110 is sized and shaped to at least span a first target area of ​​the subject's head, and the headband generally and partially conforms to the contour of the subject's head. The central portion 2111 is configured to directly or indirectly hold EEG electrodes 2310, which can be electrically connected to a power supply and processing unit. The tDCS electrode holder 2120 is configured to directly or indirectly hold tDCS electrodes. When the head-mounted device frame is worn on the subject's head, the EEG electrodes are positioned near or in contact with the first target area of ​​the subject's head, and the tDCS electrodes are positioned to or in contact with a second target area of ​​the subject's head.

[0215] In some implementations, the first region is or includes the T4 region and / or the FP1 region; and / or the second region is or includes the F3 region and / or the F4 region of the brain.

[0216] In one embodiment, the headband 2110 is made of a flexible material (such as soft plastic materials known in the art) so that it flexibly conforms to the contours of the subject's head. In another embodiment, the headband 2110 is made of a rigid material (such as rigid plastic). Example 3

[0217] 6. Example wearable device including example EEG module

[0218] Now for reference Figure 6Another example wearable device 3000 is shown, including an example EEG module 3200. In this example, in addition to the EEG module 3200, the example wearable device 3000 typically includes a processing unit 3500 and a battery 3700. The battery 3700 is electrically connected to other components to provide a power supply. The EEG module 3200 is configured to be operatively connected to and communicate bidirectionally with the processing unit 3500, wherein the processing unit 3500 is configured to control the EEG module 3200 by transmitting configuration parameters, and the EEG module 3200 is configured to acquire EEG data and send it back to the processing unit 3500 for data processing, thereby assessing the subject's neurological condition.

[0219] In one embodiment, the wearable device 3000 further includes a low-dropout regulator (LDO) 3702, an indicator 3001, an amplifier 3703, one or more buttons 3002, a battery protection module 3701, a charging management chip 3801, a 32V DC-DC converter 3802, a constant current circuit 3803, and a load 3804. The LDO 3702 is electrically connected to the battery 3700, the EEG module 3200, the indicator 3001, and the processing unit 3500. The LDO 3702 is a linear regulator that performs a step-down operation on the voltage from the battery 3700 and provides power from the battery 3700 while maintaining a stable output voltage 3700 for components such as the EEG module 3200 and the processing unit 3500, even when the input voltage is very close to the output voltage. The charging management chip 3801 is electrically connected to the battery protection module 3701, which is electrically connected to the battery 3700. In this example, the charging management chip 3801 is configured to receive a DC input 3800 and to manage the charging of the battery protection module 3701. The battery protection module 3701 is configured to protect the battery 3700 during charging and discharging. The converter 3802 is configured to boost the voltage from the battery and provide another power supply to the constant current circuit 3803, which also receives power from the processing unit 3500. The constant current circuit 3803 is configured to output to a load 3804 and provide voltage sampling to an amplifier 3703, which provides load detection to the processing unit 3500. The processing unit 3500 is configured to receive or detect an input signal from the button 3002 to trigger operation, and is also configured to control the operation of the indicator 3001, control the boost voltage of the converter 3802, and control the constant current flowing to the constant current circuit 3803. The processing unit 3500 is also configured to receive or detect the battery charge and / or power output level of the battery 3700. The processing unit 3500 is also configured to provide power to the amplifier 3703 and to process load detection from the amplifier 3703.

[0220] In some embodiments, the device 3000 further includes a tDCS module configured to be operatively connected to a separate processing unit and / or a separate battery. Example 4

[0221] 7. Example wearable device including example EEG module and TDCS module

[0222] Now for reference Figure 7 Another example wearable device 4000 is shown, including an example EEG module 4200 and an example tDCS module 4300. Similar to Example 3, the example wearable device 4000 also includes a processing unit 4500 and a battery 4700. In one embodiment, the wearable device 4000 further includes a low-dropout regulator (LDO) 4702, an indicator 4001, an amplifier 4703, one or more buttons 4002, a battery protection module 4701, a charging management chip 4801, a 32V DC-DC converter 4802, a constant current circuit 4803, and a load 4804. The detailed structure and configuration are similar to those described in Example 3, and therefore will not be repeated herein for the sake of brevity. In this example, the charging management chip 4801 is configured to receive a DC input 4800 and is configured to manage the charging of the battery protection module 4701. In this example, the LDO 4702 also provides power from the battery 4700 to the tDCS module 4300. The tDCS module 4300 is also configured to be operatively connected to and bidirectionally communicate with the processing unit 4500, wherein the processing unit 4500 is configured to control the tDCS module 4300 by transmitting configuration parameters, and the tDCS module 4300 is configured to receive tDCS protocols from the processing unit 4500. The tDCS module 4300 is configured to provide electrical stimulation to at least one target brain region of the subject to modulate the subject's neurological symptoms. Example 5

[0223] 8. Example wearable devices

[0224] Now for reference Figures 8A to 8D Another example embodiment of a wearable device 5000 for assessing and / or modulating neurological conditions in a subject is shown. In this example, the wearable device 5000 typically includes a headband frame 5100, an electroencephalogram (EEG) module 5200 configured to acquire at least one set of EEG data (from a first target region) of the subject, and a transcranial direct current stimulation (tDCS) module 5300 configured to stimulate at least one target brain region (i.e., a second target region) of the subject.

[0225] The head-mounted device frame 5100 is typically a headband-shaped shell or curved frame, its shape and size configured to generally conform to the contours of the subject's head. The head-mounted device frame 5100 is sized and shaped to allow it to be worn on the subject's head and includes a headband 5110 and a tDCS electrode holder 5120. In this example, the head-mounted device frame 5100 is curved and configured to rest above the forehead and along the top of the head, thereby providing stable physical contact with the forehead when worn by the subject. The head-mounted device frame design allows for a secure attachment of the wearable device to comfortably fit the subject's head size.

[0226] The headband 5110 includes a central portion 5111, a first arm portion 5112, and a second arm portion 5113. In this example, the first arm portion 5112 and the second arm portion 5113 extend from the central portion 5111 at two opposite ends of the central portion 5111 (and are integral with the central portion). These three portions are configured to form a U-shaped headband, the size and shape of which are set to at least span a portion of the subject's head (and at least cover a first target area). The central portion 5111 is configured to hold the EEG module 5200 on its inner side, facing the subject's head. In this example, the central portion 5111 further includes a top support base 5115 and an EEG support band 5114 located on its inner side. The EEG support band 5114 is made of a flexible material (such as silicone) and is configured to attach to the inner side of the central portion 5111. The EEG support band 5114 includes a central portion attached to a top support base 5115, and two curved end portions attached to the central portion (or located near the first or second arm portion). The top support base 5115 provides support to the flexible EEG support band 5114 and has a thickness to space the EEG support band 5114 from the central portion 5111. An EEG electrode 5210 is disposed on the inner side of the EEG support band and operatively connected to the central portion 5111 via the top support base 5115. Thus, the EEG support band provides flexible contact between the EEG electrode and the subject's head, adapting to various sizes and shapes of the subject's head. In this example, the top support base 5115 is made of a rigid plastic such as acrylonitrile butadiene styrene (ABS). In this example, the EEG support band 5114 is made of a soft material such as silicone.

[0227] The tDCS electrode holder 5120 is configured to hold the tDCS electrodes 5310A and 5310B (collectively referred to as 5310) of the tDCS module 5300. The tDCS electrode holder 5120 is typically a T-shaped member including a lateral electrode holding portion 5121 and a neck portion 5122. The neck portion 5122 extends longitudinally from or is attached to the top side of the central portion 5111 and bends inward (i.e., toward the subject's head). The neck portion 5122 is configured to be switchable between at least a retracted position and an extended position to allow longitudinal adjustment of the position of the tDCS electrode located near a target area (second target area) on the subject's head, thus allowing for different sizes and shapes. In one embodiment, the means for switching between the retracted and extended positions includes a telescopic sliding mechanism, wherein the neck portion includes an inner member slidably received within an outer member, and a friction-fitted or spring-loaded pawl releasably locks the neck portion in the selected position. Alternatively, other mechanisms known in the art may be used.

[0228] The lateral holding portion 5121 extends from or attaches to the neck portion 5122 and curves to conform to the subject's head. In this example, tDCS electrodes 5311A and 5311B (collectively referred to as 5311) comprise multiple conductive silicone electrodes arranged to form a comb-like or brush-like configuration and received in disc-shaped tDCS electrode sockets 5310A and 5310B (collectively referred to as 5310), respectively. In one embodiment, at least one tDCS electrode is configured to be slidably movable relative to the lateral electrode holding portion. Each of the tDCS electrode sockets 5310 is movably connected to the lateral holding portion 5121 via a slide rail 5123 to allow lateral adjustment of the position of the tDCS electrode located near a target area (second target area) on the subject's head to accommodate different sizes and shapes.

[0229] Now for reference Figure 8E , Figure 8F and Figure 8G The illustration shows a subject 500 wearing the wearable device 5000. In this example, EEG electrodes are adjusted and positioned near or in contact with a first target area (i.e., the forehead, including FP1 and / or FP2 areas) to collect at least one set of EEG data. tDCS electrodes are adjusted and positioned near or in contact with a second target area (i.e., F3 and / or F4 areas) to stimulate at least one target brain region of the subject.

[0230] In some other embodiments, the head-mounted device frame of the wearable device 5000 further includes a curved portion (e.g., similar to Example 1) and contains EEG electrodes at the second arm portion to collect at least one set of EEG data also targeting the subject's T4 region. In other embodiments, the head-mounted device frame has other sizes and shapes for targeting other desired target areas of the target head.

[0231] In some embodiments, the wearable device also includes a central control unit (microprocessor), a wireless communication module (such as a Wi-Fi module and / or a Bluetooth module), a battery, status sensors (such as an infrared sensor), etc. In this example, the battery is a 300 mAh battery that can be charged via a Type-C port or a magnetic port. In one embodiment, the wearable device 5000 also includes an indicator, such as an RGB light. In one embodiment, the tDCS electrode of the tDCS module 5311 provides the subject with a current of approximately 1.5 mA to approximately 2 mA. In this example, the current amplitude of the tDCS module 5311A is adjustable. In this example, the central control unit is a microcontroller unit (MCU) that stores and processes data from the wearable device 5000, wirelessly transmits and receives data, and controls the overall operation of the device (including the operation of the EEG module and the current amplitude of the tDCS module).

[0232] In some implementations, wearable devices have the following technical specifications:

[0233] 1. Product Overview • Product Use: Suitable for head massage therapy to relieve fatigue. • Expected users: Regular users. • Operator: User. • Usage location: Home and outdoor use. • Usage environment: Normal environment. • Number of patterns: 1. • Number of channels: Single channel. • Display screen: None. • Indicator light: RGB. • Product colors: Dark blue and light blue. • Battery capacity: 300 mAh. • Charging port: Type-C. 2. Product Parts Description Component • Button: Power button. • Display / Indication Area: Indicator lights. • Output terminal: comb-shaped electrode. 3. Power supply method • This product uses DC 5V charging. • The charging port here is for magnetic charging. • Recommended charger input: 5 V, 500 mA or above. • Charging protection voltage range: 4.8 V to 5.2 V. 4. Size and weight • Product dimensions: 201.8×163.2×92.6 mm. • Product weight: Approximately 180 g. 5. Product Functions Button Function • The main unit has a button. • Press and hold for 1 second to turn on. • Press and hold for 1 second to turn off. Indicator Function • This product uses RGB indicator lights. • Low battery: The yellow light stays on for 10 seconds, then the device shuts down. • While charging: The red light stays on. • When fully charged: the green light stays on. • During operation: Green light flashes. Timer function • The default working time is 15 minutes, and the timer only starts when there is output. • The device will automatically shut down after the timer expires. • If there is no output, the device will automatically shut down after 5 minutes of inactivity. • For low voltage alarms, the warning lasts for 10 seconds, then the device automatically shuts down. • The output ramp time can be adjusted via the app. • Adjustable range: 0 seconds to 600 seconds. • Default ramp time: 30 seconds. • The output cannot be adjusted while it is running. Battery power detection and low battery warning • If the battery voltage is 3.9 V or higher, the battery capacity is over 75%. • If the battery voltage is below 3.9 V but at least 3.6 V, the battery capacity is 50% to 75%. • If the battery voltage is below 3.6 V but at least 3.3 V, the battery capacity is 25% to 50%. • If the battery voltage is below 3.3 V, the battery level is below 25%, and a low voltage warning is triggered. Bluetooth function • The main unit has Bluetooth functionality. • The mobile app will be developed by the client. • Provides Bluetooth communication protocol. • It retains the OTA (over-the-air) update function, so the device firmware can be updated via Bluetooth. 6. Product parameter requirements Battery • Battery specifications: 300 mAh. • Charging current: 258 mA ± 10%. • Charging time: It takes about 2 hours to fully charge the battery from low power. Static current requirements • When this product is turned off, the battery discharge current (quiescent current) must be less than 30 uA. Output parameters • One channel, one mode, four intensity levels. • The default setting after powering on is level 0. • Pulse frequency: None. • Pulse width: None. • Output waveform: None. • Load detection: Currently unavailable. • The hardware retains this functionality, but the software has not yet been designed for it. • Output strength requirement: When the load is 10 kΩ or less, the maximum constant current is 2 mA, with an allowable error of 10%. 7. Operating and User Manual • This button is only used to turn the device on and off. • All other control functions are handled through the app. • The main unit supports four intensity levels: 0.5 mA, 1 mA, 1.5 mA, and 2 mA. • The app supports adjusting the start, pause, and ramp time. • Retain OTA functionality so that internal firmware can be upgraded remotely via an app. • After the output starts, the intensity gradually increases to the target output current. • The ramp time can be adjusted between 0 seconds and 600 seconds. • The default ramp time is 30 seconds. 8. Environmental conditions Working conditions • Ambient temperature: +5°C to +40°C. • Relative humidity: 30% RH to 75% RH. • Atmospheric pressure: 700 hPa to 1060 hPa. Transportation and storage conditions • Ambient temperature: -20°C to +55°C. • Relative humidity: 10% RH to 90% RH. • Atmospheric pressure: 500 hPa to 1060 hPa. Example 6

[0234] 9. Example System

[0235] Now for reference Figure 9 An example system 600 for assessing and / or modulating neurological conditions in a subject is illustrated. System 600 typically includes at least one or more example wearable devices 600-1…n (collectively referred to as 6000) (as described in any of the previous examples) and at least one or more terminals 6100-1…n (collectively referred to as 6100). In some embodiments, each of the wearable devices 6000 includes an EEG module, a tDCS module, and a wireless communication module configured to communicate wirelessly with each of the terminals 6100.

[0236] In one embodiment, the wearable device 6000 further includes a microprocessor that analyzes at least one set of EEG data obtained from the EEG module of the wearable device 6000 to generate at least one assessment of a neurological condition of a subject wearing the wearable device. The microprocessor is configured to generate a tDCS protocol based on the at least one assessment, such that the tDCS protocol is tailored to the subject's neurological condition. The tDCS module is configured to stimulate at least one target brain region (second region) of the subject according to the tDCS protocol. In this embodiment, the terminal 6100 serves as a user interface (e.g., via an app) to control the wearable device 6000 to receive, transmit, and / or display results including at least one set of EEG data, at least one assessment, and the tDCS protocol. In other embodiments, at least one set of EEG data is transmitted to the terminal 6100 for analysis, wherein at least one assessment is generated partially or entirely by the terminal, and the tDCS protocol is generated partially or entirely by the terminal 6100. The tDCS protocol is then transmitted to the wearable device 6000 for execution by the tDCS module, thereby stimulating the target brain regions of the subject. In another implementation, the terminal 6100 is a smartphone, tablet, personal computer, and / or a dedicated remote control.

[0237] In some embodiments, system 600 further includes one or more remote servers 6200. In another embodiment, the one or more remote servers 6200 wirelessly communicate with each of wearable device 6000 and / or at least one terminal 6100. At least one set of EEG data is transmitted directly or indirectly to the remote server 6200 for analysis, wherein at least one evaluation is generated partially or entirely by the remote server 6200, and the tDCS scheme is generated partially or entirely by the remote server 6200. The tDCS scheme is then transmitted directly or indirectly to wearable device 6000 for execution by the tDCS module to stimulate target brain regions of the subject. In some other embodiments, the remote server further includes an AI module as described in any of the foregoing examples. Example 7

[0238] 10. Example Method

[0239] Now for reference Figure 10 An example method 7000 is shown for assessing and / or modulating a subject's neurological condition using a wearable device or system as described in any of the foregoing examples. Method 700 includes the following steps:

[0240] (a) Obtaining at least one set of EEG data from a subject wearing the wearable device as described in any one of claims 1 to 18 by at least one EEG module;

[0241] (b) Optionally, at least one set of EEG data is transmitted to a terminal or remote server (if present) by the wireless communication module of the wearable device.

[0242] (c) Analyze at least one set of EEG data by at least one wearable device, at least one terminal and / or at least one remote server to generate at least one assessment of the subject’s neurological condition;

[0243] (d) A tDCS protocol is generated based on at least one assessment by at least one wearable device, at least one terminal and / or at least one remote server, such that the tDCS protocol is customized according to the subject's neurological condition;

[0244] (e) Optionally, the tDCS scheme is transmitted to the wireless communication module of the wearable device by at least one terminal and / or at least one remote server (if present); and

[0245] (f) The tDCS protocol is executed by the tDCS module to stimulate at least one target brain region of the subject.

[0246] In one implementation, method 7000 further includes the following steps:

[0247] (g) Obtain at least one heart rate data of the subject from the heart rate sensor module.

[0248] In one implementation, step (f) further includes the following steps:

[0249] (f1) At least one target brain region of the subject is stimulated by at least one tDCS module with a current of approximately 1.5 mA to approximately 2 mA.

[0250] The systems and methods disclosed herein can be implemented in the form of software applications running on a computer system. Further, a portion of the method may execute on one such computer system, while other portions may execute on one or more other such computer systems. Examples of computer systems include mainframes, personal computers, handheld computers, servers, etc. The software application may be stored on a recording medium that is locally accessible by the computer system and accessible via a hardwired or wireless connection to a network (e.g., a local area network or the Internet).

[0251] A computer system may include, for example, a processor, random access memory (RAM), a printer interface, a display unit, a local area network (LAN) data transmission controller, a LAN interface, a network controller, an internal bus, and one or more input devices (e.g., a keyboard, a mouse, etc.). The computer system may be connected to a data storage device.

[0252] The boxes and / or methods discussed herein can be executed and / or formulated by users, user agents (including machine learning agents and intelligent user agents), software applications, electronic devices, computers, firmware, hardware, processes, computer systems, and / or intelligent personal assistants. Furthermore, the boxes and / or methods discussed herein can be executed automatically, with or without instructions from the user.

[0253] Those skilled in the art should understand that the distinction between hardware and software is a conceptual division made for ease of understanding and is, to some extent, arbitrary. Furthermore, it should be understood that peripheral devices in one computer device can be integrated into the host computer of another computer device. Moreover, application software systems can execute in a distributed computing environment. Software programs and their associated databases can be stored on a separate file server or database server and transferred to the local host for execution.

[0254] Exemplary embodiments of the present invention have thus been fully described. Although the description refers to specific embodiments, those skilled in the art will understand that the invention can be practiced with variations of these specific details. Therefore, the invention should not be construed as being limited to the embodiments set forth herein.

[0255] The methods discussed in different figures can be added to the methods in other figures, or exchanged with the methods in other figures. Furthermore, specific numerical data values ​​(such as specific quantities, numbers, categories, etc.) or other specific information should be interpreted as illustrative, used to discuss exemplary embodiments. Such specific information is not provided to limit the exemplary embodiments.

Claims

1. A wearable device for assessing and / or modulating neurological disorders in a subject, said wearable device comprising: (a) Headset frame; (b) An electroencephalogram (EEG) module, the EEG module comprising at least one EEG electrode; as well as (c) A transcranial direct current stimulation (tDCS) module, the tDCS module comprising at least one tDCS electrode, The EEG module is configured to obtain at least one set of EEG data from the subject. The tDCS module is configured to stimulate at least one target brain region of the subject; and The head-mounted device frame further includes: (a1) A headband comprising a central portion, a first arm portion and a second arm portion, the size and shape of the headband being configured to at least span a first region of the subject’s head, wherein the central portion is configured to hold the at least one EEG electrode. (a2) A tDCS electrode holder, the tDCS electrode holder being configured to hold the at least one tDCS electrode, and When the head-mounted device frame is worn on the subject's head, at least one EEG electrode is positioned near or in contact with the first target area, and at least one tDCS electrode is positioned in or in contact with the second target area of ​​the subject's head.

2. The wearable device as described in claim 1, wherein, The first area is or includes the T4 area, the FP1 area and / or the FP2 area; and / or the second area is or includes the F3 area and / or the F4 area.

3. The wearable device as described in claim 1, wherein, The tDCS electrode holder includes a lateral electrode holder portion and a neck portion; The neck portion is integral with or attached to the central portion on its lower side, and integral with or attached to the lateral electrode holding portion on its upper side; and The neck portion is configured to be able to switch between at least a retracted position and an extended position.

4. The wearable device of claim 1, further comprising a wireless communication module for communicating with at least one terminal and / or at least one remote server.

5. The wearable device as described in claim 4, wherein, The wireless communication module is configured to transmit the at least one set of EEG data to the at least one terminal and / or the at least one remote server for analysis, and is configured to receive the tDCS scheme from the at least one terminal and / or the at least one remote server; and The tDCS scheme is determined based on the analysis of the at least one set of EEG data.

6. The wearable device as described in claim 5, wherein, The at least one tDCS module is configured to stimulate the at least one target brain region of the subject wearing the wearable device according to the tDCS protocol.

7. The wearable device of claim 1, further comprising a flexible EEG support band extending from or attached to the inner surface of the central portion, wherein, The at least one EEG electrode includes three EEG electrodes positioned on the EEG support strip.

8. The wearable device as described in claim 3, wherein, The at least one tDCS electrode includes two TDCS electrodes positioned at or near both ends of the lateral electrode holding portion.

9. The wearable device as claimed in claim 1, wherein, Each of the tDCS electrodes includes a plurality of conductive silicone electrodes arranged to form a comb-like or brush-like configuration.

10. The wearable device of claim 3, wherein, The at least one tDCS electrode is configured to be slidably movable relative to the lateral electrode holding portion.

11. The wearable device of claim 1, wherein, The at least one tDCS module includes a plurality of tDCS electrodes, each tDCS electrode being configured to stimulate at least a portion of the target brain region of the subject with a current of about 1.5 mA to about 2 mA.

12. The wearable device as claimed in claim 1, wherein, The neurological disorders include cognitive impairment (COI), anxiety disorders, depression, and / or attention deficit hyperactivity disorder (ADHD).

13. The wearable device of claim 5, further comprising a processing unit configured to analyze the at least one set of EEG data and determine the tDCS scheme.

14. The wearable device of claim 1, further comprising a heart rate sensor module configured to acquire at least one set of heart rate data of the subject.

15. The wearable device of claim 1, further comprising a rechargeable battery and a battery charging port optionally electrically connected to the EEG module and the tDCS module.

16. The wearable device of claim 1, further comprising a wearing state module, the wearing state module being configured to determine the wearing state of the wearable device, wherein, The wearing status includes the subject's wearing status on the head and the wearing status outside the head.

17. The wearable device of claim 16, wherein, The wearing status module includes an infrared sensor.

18. A wearable device for assessing and / or modulating neurological disorders in a subject, said wearable device comprising: (a) Headset frame; (b) An electroencephalogram (EEG) module, the EEG module comprising two EEG electrodes; as well as (c) A transcranial direct current stimulation (tDCS) module, the tDCS module comprising three tDCS electrodes; (d) A wireless communication module for communicating with at least one terminal and optionally at least one remote server; (f) A rechargeable battery and a battery charging port optionally electrically connected to the EEG module and the tDCS module; and (h) A processing unit configured to analyze the at least one set of EEG data and determine a tDCS scheme. The EEG module is configured to obtain at least one set of EEG data from the subject. The tDCS module is configured to stimulate at least one target brain region of the subject. The wireless communication module is configured to transmit the at least one set of EEG data to a terminal or remote server for analysis, and is configured to receive the tDCS scheme from the terminal or the remote server; and The head-mounted device frame further includes: (a1) A headband comprising a central portion, a first arm portion, an opposite second arm portion, and a flexible EEG support band extending from or attached to the inner surface of the central portion, wherein three EEG electrodes are positioned on the EEG support band, the size and shape of the headband being configured to at least span the T4 and / or FP1 regions of the subject's head, wherein the central portion is configured to hold the three EEG electrodes; (a2) A tDCS electrode holder, the tDCS electrode holder comprising a lateral electrode holder portion and a neck portion, the tDCS electrode holder being configured to hold the two tDCS electrodes. The neck portion is integral with or attached to the central portion on the lower side, and integral with or attached to the lateral electrode holding portion on the upper side. The neck portion is configured to be able to switch between at least a retracted position and an extended position; Wherein, when the head-mounted device frame is worn on the subject's head, at least one EEG electrode is positioned near or in contact with the subject's FP1 and / or FP2 areas, and at least one tDCS electrode is positioned in or in contact with the subject's F3 and / or F4 areas. Each of the tDCS electrodes includes a plurality of conductive silicone electrodes arranged to form a comb-like or brush-like configuration; each of the two tDCS electrodes includes a plurality of conductive silicone electrodes arranged to form a comb-like or brush-like configuration; the two tDCS electrodes are positioned at or near both ends of the lateral electrode holding portion and are slidably movable relative to the lateral electrode holding portion; and The tDCS protocol is determined based on the analysis of the at least one set of EEG data, and the at least one tDCS module is configured to stimulate at least one target brain region of the subject wearing the wearable device according to the tDCS protocol, and each comb or brush conductive silicone electrode is configured to stimulate at least a portion of the target brain region of the subject with a current of about 1.5 mA to about 2 mA.

19. A system for assessing and / or modulating neurological disorders in a subject, the system comprising: (a) at least one wearable device as claimed in any one of claims 1 to 18; (b) At least one terminal; as well as (c) Optionally, at least one remote server, The at least one terminal and optionally the at least one remote server are communicatively connected to each of the at least one wearable device. The system is configured as follows: (i) Analyzing at least one set of EEG data obtained from the EEG module of the wearable device to generate at least one assessment of the neurological condition of the subject wearing the wearable device; and / or (ii) Generate a tDCS protocol based on the at least one assessment, such that the tDCS protocol is tailored to the subject's neurological condition. The tDCS module is configured to stimulate at least one target brain region of the subject according to the tDCS protocol.

20. The system of claim 19, wherein, Each of the at least one remote server is a cloud-based platform that wirelessly communicates with the at least one wearable device and / or the at least one terminal.

21. The system of claim 19, wherein, The neurological disorders include cognitive impairment (COI), anxiety disorders, depression, and / or attention deficit hyperactivity disorder (ADHD).

22. A method for assessing and / or modulating a subject's neurological condition, the method comprising the steps of: (a) Obtaining at least one set of EEG data from a subject wearing the wearable device as described in any one of claims 1 to 18 by at least one EEG module; (b) Optionally, the at least one set of EEG data is transmitted to a terminal or a remote server by the wireless communication module of the wearable device; (c) Analyze the at least one set of EEG data by the at least one wearable device, the at least one terminal and / or the at least one remote server to generate at least one assessment of the subject’s neurological condition; (d) A tDCS plan is generated by the at least one wearable device, the at least one terminal and / or the at least one remote server based on the at least one assessment, such that the tDCS plan is customized according to the subject's neurological condition; (e) Optionally, the tDCS scheme is transmitted to the wireless communication module of the wearable device by the at least one terminal and / or the at least one remote server; as well as (f) The tDCS protocol is executed by the tDCS module to stimulate at least one target brain region of the subject.

23. The method of claim 22, further comprising the following steps: (g) Obtain at least one heart rate data of the subject from the heart rate sensor module.

24. The method of claim 22, wherein, Step (f) further includes the following steps: (f1) The subject’s at least one target brain region is stimulated by the at least one tDCS module with a current of about 1.5 mA to about 2 mA.

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