headgear

Abstract

In one aspect headgear (10) is disclosed. In one arrangement and embodiment, the headgear (10) is adjustable to position an item (14) on a head (16) of a wearer (12), so that, when worn, the position of the item (14) relative to the head (16) corresponds to a criteria. In an embodiment, the item (14) comprises an output of a stimulator for providing a stimulation output, for providing stimulation of, or stimulating, the brain of the wearer (12).

Description

HEADGEARTECHNICAL FIELD

[0001] The present invention relates generally to headgear.

[0002] The present invention will be described with particular reference to headgear for providing brain stimulation.

[0003] However, it will be appreciated that the invention is not limited to this particular field of use, and it may be used in respect of other purposes.BACKGROUND

[0004] Any discussion of the background art throughout this specification should in no way be considered as an admission that such background art is prior art, nor that such background art is widely known or forms part of the common general knowledge in the field in Australia or worldwide.

[0005] All references, including any patents or patent applications, cited in this specification are hereby incorporated by reference. No admission is made that any reference constitutes prior art. The discussion of the references states what their authors assert, and the applicant reserves the right to challenge the accuracy and pertinence of the cited documents. It will be clearly understood that, although a number of prior art publications may be referred to herein, this reference does not constitute an admission that any of these documents forms part of the common general knowledge in the art, in Australia or in any other country.

[0006] Chronic musculoskeletal pain is a common consequence of musculoskeletal injury. Pain medications may be helpful, however they are not appropriate for all patients and many can be addictive. Current best practice for managing chronic musculoskeletal pain is getting stronger via exercise, however, increasing strength / control is challenging for many people.

[0007] One maladaptive system in many musculoskeletal conditions is the brain’s motor cortex, which is responsible for muscle activation. Generally speaking, in people without pain / injury / disability, when a muscle contracts, the motor cortex ‘turns on theaccelerator’ and ‘releases the brake’ in respect of the muscle, facilitating the desired muscle movement. However, people with chronic musculoskeletal pain cannot fully ‘release the brake’, which may be referred to or termed ‘cortical inhibition’. Therefore, people with pain are unable to produce maximal muscle force, as the brain is actively inhibiting force production, preventing recovery. Therefore, cortical inhibition limits outcomes from exercise rehabilitation, preventing the improvement of strength / control. Non-invasive electrical brain stimulation has been shown in a plethora of studies to improve cortical inhibition, which enables people to fully activate the areas of the brain responsible for muscle activation. Thus, increasing strength / control, leading to or towards normal function and a reduced healthcare burden.

[0008] Transcranial Direct Current Stimulation (tDCS) is one form of non-invasive electrical brain stimulation. Particularly, it is a form of neuromodulation that uses constant, low direct current delivered via electrodes on the head. Generally speaking, it works by sending constant, low direct current through the electrodes. When these electrodes are placed in the region of interest, the current induces intracerebral current flow. This current flow then either increases or decreases the neuronal excitability in the specific area being stimulated based on which type of stimulation is being used. This change of neuronal excitability leads to alteration of brain function, which can be used in various therapies as well as to provide more information about the functioning of the brain. tDCS is a relatively simple technique requiring only a few parts. These include two electrodes and a control unit device that delivers current. Each device has an anodal, positively charged electrode and a cathodal, negatively charged electrode. Current is ‘conventionally’ described as flowing from the positive anode, through the intervening conducting tissue, to the cathode, creating a circuit. The device may control the current as well as the duration of stimulation.

[0009] Existing tDCS devices, whilst prevalent in research settings and increasingly adopted by self-taught enthusiasts and video game players, exhibit significant limitations in their practical application. Existing devices generally consist only of the control unit with two cables that lead to sponges that represent the anode and cathode (like a transcutaneous electrical nerve stimulation (TENS) device). When trying to apply tDCS stimulation to different regions of the brain (such as the motor cortex or dorsolateral pre-frontal cortex, for example) existing devices require external fixation to fit to the head, which typically require users to place the sponges within nets orheadbands to stabilise the anode or cathode electrodes. These devices often fail to supply sufficient contact of the electrode to the skin, which provides insufficient contact, impedes comfort, and precludes them from use in physical activity. Existing devices are not user-friendly and also require users to conduct laborious measurements of their head to locate the appropriate brain regions for stimulation.

[0010] Finally, to activate the motor cortex, it is common that for anode / cathode placement, one anode / cathode is placed on the head overlying the motor cortex and the other is placed over the upper arm of the user (for example, on the shoulder blade or outer region of the upper arm (over the deltoid). This is presently inadequately facilitated or impossible with equipment provided by current devices, and technically challenging even when using other equipment to assist set up. This precludes current devices from being able to easily activate the motor cortex in accordance with manufacturers current recommendations for electrode placement.

[0011] It is against this background that the present invention has been developed.SUMMARY OF INVENTION

[0012] It is an object of the present invention to overcome or ameliorate at least one or more of the disadvantages of the prior art, to provide a useful alternative, and / or to provide consumers with a commercial choice.

[0013] According to a first broad aspect of the present invention, there is provided headgear adjustable to position an item on a head of a wearer, so that, when worn, the position of the item relative to the head corresponds to a criteria.

[0014] The headgear may be adjustable to position more than one item on the head of the wearer, so that, when worn, the position of each of the more than one item relative to the head corresponds to a respective criteria, which may be the same or vary according to the item.

[0015] The item may be output of a stimulator for providing a stimulation output, in which case the headgear may be for providing stimulation of, or stimulating, the brain of the wearer.

[0016] The stimulator may comprise a controller and storage storing electronicprogram instructions for controlling the controller, wherein the controller is operable, under control of the electronic program instructions, to generate and provide the stimulation output.

[0017] The stimulation output may comprise an electrical current for stimulation, which may include one or more types of non-invasive brain stimulation, including: Transcranial Direct Current Stimulation (tDCS); Transcranial Random Noise Stimulation (tRNS); and Transcranial Alternating Current Stimulation (tACS).

[0018] The item may comprise an electrode of the stimulator.

[0019] The item and / or the stimulator, where provided, may be removably connectable to the headgear. Alternatively, the item and / or the stimulator, where provided, may be integrated with the headgear.

[0020] The criteria may comprise a specification or condition relating to the position or placement of the item relative to the head. The specification may comprise the 10-20 system for electroencephalogram (EEG) electrode positioning.

[0021] The headgear may comprise a first headband adapted to fit circumferentially around and abut the head of the wearer when worn, and a second headband movably coupled to the first headband so as to be moveable between a plurality of operating positions.

[0022] The coupling may allow for movement of the second headband in a first direction relative to the first headband, in a second direction relative to the first headband, and in a third direction relative to the first headband.

[0023] The first direction may comprise a horizontal direction, the second direction may comprise a vertical direction, and the third direction may comprise a rotational direction.

[0024] There may be a relationship between moveable portions of the headgear such that when movement of the moveable portions occurs, the criteria remains satisfied.

[0025] The relationship may comprise a ratio between moveable portions of theheadgear.

[0026] The headgear may be connectable, or connected, to an other wearable for positioning an other item on an other part of the body of the wearer.

[0027] The other wearable may comprise an armband.

[0028] According to a second broad aspect of the present invention, there is provided a method comprising adjustably positioning an item on a head of a wearer, so that, when worn, the position of the item relative to the head corresponds to a criteria.

[0029] The method may comprise adjustably positioning more than one item on the head of the wearer, so that, when worn, the position of each of the more than one item relative to the head corresponds to a respective criteria, which may be the same or vary according to the item.

[0030] The item may be output of a stimulator for providing a stimulation output, in which case the method may be for providing stimulation of, or stimulating, the brain of the wearer.

[0031] The stimulator may comprise a controller and storage storing electronic program instructions for controlling the controller, wherein the method further comprises operating the controller, via the electronic program instructions, to generate and provide the stimulation output.

[0032] The stimulation output may comprise an electrical current for stimulation, which may include one or more types of non-invasive brain stimulation, including: Transcranial Direct Current Stimulation (tDCS); Transcranial Random Noise Stimulation (tRNS); and Transcranial Alternating Current Stimulation (tACS).

[0033] The item may comprise an electrode of the stimulator.

[0034] The criteria may comprise a specification or condition relating to the position or placement of the item relative to the head. The specification may comprise the 10-20 system for electroencephalogram (EEG) electrode positioning.

[0035] According to a third broad aspect of the present invention, there is providedheadgear comprising: a circumferential headband adapted to fit circumferentially around and abut a head of a wearer when worn; a top headband coupled to the circumferential headband so as to be adjustable vertically and rotationally; an adjustment means for adjusting fit of the headgear to the wearer’s head; and at least one electrode housing at a location on at least one of the circumferential headband or the top headband, the at least one electrode housing for housing an electrode of a stimulator for providing a stimulation output via the electrode, the location according to a specification relating to position of the electrode relative to the head, wherein the specification comprises the 10-20 system for electroencephalogram (EEG) electrode positioning, a ratio between the circumferential headband and the top headband preserved during fit adjustment of the headgear via the adjustment means so that the relative position of the electrode housing remains satisfying the 10-20 system for EEG electrode positioning.

[0036] Other objects and advantages of the present invention will become apparent from the following description, taken in connection with the accompanying drawings, wherein, by way of illustration and example, a preferred embodiment of the present invention is disclosed.BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Notwithstanding any other forms which may fall within the scope of the present invention, in order that the invention may be more fully understood and put into practice, preferred embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0038] Figure 1 depicts a perspective view of a particular arrangement of a headset implementing headgear in accordance with an aspect and embodiment of the presentinvention;

[0039] Figure 2 depicts an exploded view of components of the headset;

[0040] Figures 3A to 3E depict respective Front, Side, Rear, Top / Upper, andBottom / Under side views of the headset;

[0041] Figures 4A to 4D depict respective movement of the headset between different operating positions;

[0042] Figures 5A and 5B depict connection of a device to the headset;

[0043] Figures 6A to 6D depict a rotating (pin joint) mechanism of the headset;

[0044] Figures 7A and 7B depict multiple pivot positions of the rotating (pin joint) mechanism of the headset;

[0045] Figure 8 depicts a top electrode housing and adjustment of the headset;

[0046] Figure 9 depicts a front electrode housing and adjustment of the headset;

[0047] Figure 10 depicts an armband connectable to the headset;

[0048] Figure 11 depicts an exploded view of the armband;

[0049] Figure 12 depicts connection of the armband to the headset;

[0050] Figures 13A and 13B depict charging of the device connectable to the headset;

[0051] Figure 14A depicts a person wearing an alternative embodiment of the headset of Figure 1 connected to an alternative embodiment of the armband of Figure 10;

[0052] Figure 14B depicts the alternative embodiment of the armband;

[0053] Figures 15A to 15C depict movement of the alternative embodiment of the headset between different operating positions whilst being worn by the person;

[0054] Figure 16 depicts the device connected to the alternative embodiment of the headset whilst being worn by the person;

[0055] Figure 17 depicts removal of an outer of the top housing and disconnection of the device from the alternative embodiment of the headset whilst being worn by the person;

[0056] Figures 18A and 18B depict electrode placement of the headset adhering to the International 10-20 system for electroencephalogram (EEG) electrode positioning;

[0057] Figure 19 depicts the person wearing the alternative embodiment of the headset;

[0058] Figure 20 depicts a schematic diagram of the headset as part of a system for brain stimulation according to an aspect and embodiment of the present invention; and

[0059] Figures 21 to 26 depict a ratchet mechanism of the headset.DEFINITIONS

[0060] The following definitions are provided as general definitions and should in no way limit the scope of the present invention to those terms alone, but are put forth for a better understanding of the following description.

[0061] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the invention belongs. It will be further understood that terms used herein should be interpreted as having a meaning that is consistent with their meaning in the context of this specification and the relevant art and will not be interpreted in an idealised or overly formal sense unless expressly so defined herein. For the purposes of the present invention, additional terms are defined below. Furthermore, all definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms unless there is doubt as to the meaning of a particular term, in which case the common dictionary definition and / or common usage of the term will prevail.

[0062] For the purposes of the present invention, the following terms are definedbelow.

[0063] The articles “a” and “an” are used herein to refer to one or to more than one (i.e. to at least one) of the grammatical object of the article. By way of example, "an element" refers to one element or more than one element.

[0064] The term “about” is used herein to refer to quantities that vary by as much as 30%, preferably by as much as 20%, and more preferably by as much as 10% to a reference quantity. The use of the word ‘about’ to qualify a number is merely an express indication that the number is not to be construed as a precise value.

[0065] Throughout this specification, unless the context requires otherwise, the words “comprise”, “comprises” and “comprising” will be understood to imply the inclusion of a stated step or element or group of steps or elements but not the exclusion of any other step or element or group of steps or elements.

[0066] Any one of the terms: “including” or “which includes” or “that includes” as used herein is also an open term that also means including at least the elements / features that follow the term, but not excluding others. Thus, “including” is synonymous with and means “comprising”.

[0067] In the claims, as well as in the summary above and the description below, all transitional phrases such as “comprising”, “including”, “carrying”, “having”, “containing”, “involving”, “holding”, “composed of’, and the like are to be understood to be open- ended, i.e. to mean “including but not limited to”. Only the transitional phrases “consisting of’ and “consisting essentially of” alone shall be closed or semi-closed transitional phrases, respectively.

[0068] The term “real-time”, for example “displaying real-time data”, refers to the display of the data without intentional delay, given the processing limitations of the system and the time required to accurately measure the data.

[0069] The term “near-real-time”, for example “obtaining real-time or near-real-time data” refers to the obtaining of data either without intentional delay (“real-time”) or as close to real-time as practically possible (i.e. with a small, but minimal, amount of delay whether intentional or not within the constraints and processing limitations of the of thesystem for obtaining and recording or transmitting the data.

[0070] Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, preferred methods and materials are described. It will be appreciated that the methods, apparatus and systems described herein may be implemented in a variety of ways and for a variety of purposes. The description here is by way of example only.

[0071] As used herein, the term “exemplary” is used in the sense of providing examples, as opposed to indicating quality. That is, an “exemplary embodiment” is an embodiment provided as an example, as opposed to necessarily being an embodiment of exemplary quality for example serving as a desirable model or representing the best of its kind.

[0072] The various methods or processes outlined herein may be coded as software that is executable on one or more processors that employ any one of a variety of operating systems or platforms. Additionally, such software may be written using any of a number of suitable programming languages and / or programming or scripting tools, and also may be compiled as executable machine language code or intermediate code that is executed on a framework or virtual machine.

[0073] In this respect, various inventive concepts may be embodied as a computer readable storage medium (or multiple computer readable storage media) (e.g. a computer memory, one or more floppy discs, compact discs, optical discs, magnetic tapes, flash memories, circuit configurations in Field Programmable Gate Arrays or other semiconductor devices, or other non-transitory medium or tangible computer storage medium) encoded with one or more programs that, when executed on one or more computers or other processors, perform methods that implement the various embodiments of the invention discussed above. The computer readable medium or media can be transportable, such that the program or programs stored thereon can be loaded onto one or more different computers or other processors to implement various aspects of the present invention as discussed above.

[0074] The terms “program” or “software” are used herein in a generic sense to refer to any type of computer code or set of computer-executable instructions that can be employed to program a computer or other processor to implement various aspects ofembodiments as discussed above. Additionally, it should be appreciated that according to one aspect, one or more computer programs that when executed perform methods of the present invention need not reside on a single computer or processor, but may be distributed in a modular fashion amongst a number of different computers or processors to implement various aspects of the present invention.

[0075] Computer-executable instructions may be in many forms, such as program modules, executed by one or more computers or other devices. Generally, program modules include routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular abstract data types. Typically the functionality of the program modules may be combined or distributed as desired in various embodiments.

[0076] Also, data structures may be stored in computer-readable media in any suitable form. For simplicity of illustration, data structures may be shown to have fields that are related through location in the data structure. Such relationships may likewise be achieved by assigning storage for the fields with locations in a computer-readable medium that convey relationship between the fields. However, any suitable mechanism may be used to establish a relationship between information in fields of a data structure, including through the use of pointers, tags or other mechanisms that establish relationship between data elements.

[0077] Also, various inventive concepts may be embodied as one or more methods, of which an example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.

[0078] The phrase “and / or”, as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e. elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and / or” should be construed in the same fashion, i.e. “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and / or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limitingexample, a reference to “A and / or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.

[0079] As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items in a list, “or” or “and / or” shall be interpreted as being inclusive, i.e. the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of’ or “exactly one of”, or, when used in the claims, “consisting of’ will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e. “one or the other but not both”) when preceded by terms of exclusivity, such as “either”, “one of’, “only one of”, or “exactly one of”. “Consisting essentially of”, when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0080] As used herein in the specification and in the claims, the phrase “at least one”, in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, “at least one of A and B” (or, equivalently, “at least one of A or B”, or, equivalently “at least one of A and / or B”) can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.

[0081] For the purpose of this specification, where method steps are described in sequence, the sequence does not necessarily mean that the steps are to be carried out in chronological order in that sequence, unless there is no other logical manner of interpreting the sequence.DETAILED DESCRIPTION OF EMBODIMENTS

[0082] It should be noted in the following description that like or the same reference numerals in different embodiments denote the same or similar features.

[0083] The present invention will be described with particular reference to headgear for providing brain stimulation. However, it will be appreciated that the invention is not limited to this particular field of use, and it may be used in respect of other purposes.

[0084] Embodiments of the invention relate to headgear 10 (which may also be referred to as headwear or headdress), implementing a corresponding method, for providing stimulation to, or stimulating, a brain of a wearer 12. The wearer 12 may be a human, as in the embodiment described. In alternative embodiments, the wearer may be another living organism, such as an animal.

[0085] In accordance with aspects and embodiments of the invention depicted in the Figures, the headgear 10 provides for user-friendly, non-invasive, brain stimulation of the wearer 12. It can be used during exercise rehabilitation in both injured and uninjured populations.

[0086] As will be described in further detail, the embodiment of the headgear 10 addresses, or at least mitigates, limitations of existing technology by integrating anode and cathode electrodes into a headset (and optional armband), strategically positioned to enable targeting of key regions of interest, mapped according to the International IQ- 20 system for electroencephalogram (EEG) electrode positioning.

[0087] The headgear 10 comprises a plurality of components, subsystems and / or modules operably coupled via appropriate mechanics, circuitry and connections, to enable the headgear 10 to perform the functions and operations herein described.

[0088] The headgear 10 is adjustable to position an item 14 on the head 16 of the wearer 12, so that, when worn, the position of the item 14 relative to the head 16corresponds to a criteria. Particularly, in the embodiment, the headgear 10 is adjustable to position more than one item 14 on the head 16 of the wearer 12, so that, when worn, the position of each of the more than one item 14 relative to the head 16 corresponds to a respective criteria, which may be the same or vary according to the item 14.

[0089] The dimensions of the headgear 10 are as appropriate for the head 16 of the intended wearer 12 and it is sized and shaped accordingly. A ‘generic’ human male presenting head is depicted in the drawings as an example only in this regard.

[0090] The headgear 10 of the first embodiment is implemented in a headset 18 depicted in Figure 1 .

[0091] In the embodiment, the more than one item 14 is output of a stimulator for providing a stimulation output, implemented as electrodes 20 and 22 of a stimulation device 24, which may be referred to as an electronic module or stimulation module (of the headset 18). The electrodes 20 and 22 are, respectively, an anodal, positively charged electrode 20 and a cathodal, negatively charged electrode 22, together comprising an anode / cathode electrode pair.

[0092] As will be described in further detail, the device 24 is operable to generate and control delivery of electrical currents for stimulation, which may include one or more types of non-invasive brain stimulation, including Transcranial Direct Current Stimulation (tDCS), Transcranial Random Noise Stimulation (tRNS), and Transcranial Alternating Current Stimulation (tACS). It should be appreciated that the embodiment of the invention is not limited in this regard, and additional and / or alternative stimulations may be generated (by an appropriate stimulator) in alternative embodiments of the invention.

[0093] Technology for generating such stimulations is well-known to persons skilled in the art and need not be described in any further detail herein except as is relevant to the present invention.

[0094] In the embodiment, the electrodes 20 and 22 are constructed seeking to increase or maximise comfort and efficacy, and comprise conductive rubber / metal encapsulated by synthetic sponges (soaked in a saline solution prior to use). The sponges have a circular shape in the embodiment, so as to advantageously mitigate or avoid “edge effects” of variable current density that can occur with rectangular sponges.Such a design seeks to provide optimal current distribution whilst reducing or minimising wearer 12 discomfort during stimulation.

[0095] Soaking the electrodes 20 and 22 in a saline solution prior to use advantageously enhances conductivity. In the embodiment, properties of the solution, such as concentration and volume of saline, for example, are calibrated to optimise stimulation whilst reducing or minimising discomfort and leakage.

[0096] Together, the headset 18 and the device 24 (or electronic / stimulation module) may be seen to be an implementation of a stimulation system (being the headgear 10 in the embodiment), and corresponding method.

[0097] The device 24 comprises a plurality of components, subsystems and / or modules operably coupled via appropriate circuitry and connections to enable the device 24 to perform the functions and operations herein described. The device 24 comprises suitable components necessary to receive, store and execute appropriate computer instructions such as to implement a method for providing an output in accordance with embodiments of the present invention.

[0098] Particularly, and referring to Figure 20, the device 24 comprises an output means 26 operable to provide the output; a control system implemented via computing means 28 which in the embodiment comprises a controller 30 and storage 32 for storing electronic program instructions for controlling the controller 30, and information and / or data; input means 34 for receiving input; and a source 36 for providing energy to power the device 24; all housed within a device container or housing 38.

[0099] In embodiments of the invention, the energy source 36 comprises a rechargeable battery connectable to provide energy (power) as required via appropriate hardware.

[0100] In embodiments of the invention, the output means 26 and input means 34 comprise any equipment and technology as may be appropriate and / or required for the implementation. This may include components and circuitry as may be required, operably connected, to facilitate the operations described, including connectors for WiFi, power, data, and control. Particularly, in the embodiment, this includes components and circuitry allowing Bluetooth connectivity for protocol setup and adjustment.

[0101] Particularly, in the embodiment, the output means 26 is operably couplable to the electrodes 24 to provide a generated current thereto.

[0102] As will be described in further detail, the controller 30 is operable, under control of the electronic program instructions, to: receive input via the input means 34; process the input and, on the basis of the processing, generate and provide the output at the output means 26 (and to the electrodes 20, 22 coupled thereto).

[0103] In the embodiment, the output comprises current delivered to the electrodes 20 and 22 for stimulation. The stimulation may accord to a stimulation protocol. It should be appreciated that the invention is not limited in this regard, and in embodiments additional and / or other outputs may be generated.

[0104] In this regard, in the embodiment the output also comprises visual feedback and audio feedback. Visual feedback is implemented in the embodiment by light emitting diode (LED) indicators provided on the device 24 and operable to signal protocol upload and operational status of the device 24. This advantageously provides an indication that the correct or intended treatment session is being followed or implemented. Audio feedback is implemented in the embodiment and delivered by a speaker operable to provide an indication of operational status of the device 24, advantageously allowing the wearer 12 to be aware of the phase of treatment without needing to remove to headgear 10 to check. Operational status of the device 24 may include one or more of treatment commenced, finished, interrupted / loss of current consistency / change of resistance, for example.

[0105] In embodiments of the invention, the input comprises details. The details may comprise data and / or information of, associated with, and / or related to: stimulation; current to be generated and output; the wearer 12, which may include a condition of the wearer 12; and / or a treatment to be provided. The data and / or information may be obtained by one or more of capturing, retrieving, receiving, extracting, and identifying it, from one or more sources. The one or more sources of data may reside on the storage 32, and / or elsewhere, remote from the device 24.

[0106] The controller 30 comprises processing means in the form of a processor.

[0107] The storage 32 comprises read only memory (ROM) and random accessmemory (RAM).

[0108] The device 24 is capable of receiving instructions that may be held in the ROM or RAM and may be executed by the processor. The processor is operable to perform actions under control of electronic program instructions, as will be described in further detail below, including processing / executing instructions and managing the flow of data and information through the device 24.

[0109] In the embodiment, electronic program instructions for the device 24 are provided via a single standalone software application (app) or module which may be referred to as a brain stimulation app. In the embodiment described, the app can be downloaded from a website (or other suitable electronic device platform) or otherwise saved to or stored on storage.

[0110] The device 24 also includes an operating system which is capable of issuing commands and is arranged to interact with the app to cause the device 24 to carry out actions including the respective steps, functions and / or procedures in accordance with the embodiment of the invention described herein. The operating system may be appropriate for the computing components of the device 24.

[0111] As depicted in Figure 20, the device 24 is operable to communicate via one or more communications link(s) 40, which may variously connect to one or more remote devices 42 such as servers, personal computers, terminals, wireless or handheld computing devices, landline communication devices, or mobile communication devices such as a mobile (cell) telephone. At least one of a plurality of communications link(s) 40 may be connected to an external computing network through a telecommunications network.

[0112] In the embodiment described, the remote devices 42 include a mobile communication device 44 owned and / or operated by an operator 46. The operator 46 is suitably qualified and experienced to fit the headset 18 to the head 16 of the wearer 12 and operate it safely.

[0113] In the embodiment, the mobile communication device 44 comprises computing means such as a personal, notebook or tablet computer such as that marketed under the trade mark IPAD® or IPOD TOUCH®by Apple Inc, or by otherprovider such as Hewlett-Packard Company, or Dell, Inc, for example, or other suitable device. In alternative embodiments, the mobile communication device 44 may comprise a smartphone such as that marketed under the trade mark IPHONE® by Apple Inc, or by other provider such as Nokia Corporation, or Samsung Group, having Android, WEBOS, Windows, or other Phone app platform.

[0114] Electronic instructions or programs for the computing components of the device 24 can be written in any suitable language, as are well known to persons skilled in the art. In embodiments of the invention, the electronic program instructions may be provided as stand-alone application(s), as a set or plurality of applications, via a network, or added as middleware, depending on the requirements of the implementation or embodiment.

[0115] In embodiments of the invention, the software may comprise one or more modules, and may be implemented in hardware. In such a case, for example, the modules may be implemented with any one or a combination of the following technologies, which are each well known in the art: a discrete logic circuit(s) having logic gates for implementing logic functions upon data signals, an application specific integrated circuit (ASIC) having appropriate combinational logic gates, a programmable gate array(s) (PGA), a field programmable gate array (FPGA) and the like.

[0116] The computing means can be a system of any suitable type, including: a programmable logic controller (PLC); digital signal processor (DSP); microcontroller; personal, notebook or tablet computer, or dedicated servers or networked servers.

[0117] The processor can be any custom made or commercially available processor, a central processing unit (CPU), a data signal processor (DSP) or an auxiliary processor among several processors associated with the computing means. In embodiments of the invention, the processing means may be a semiconductor based microprocessor (in the form of a microchip) or a macroprocessor, for example.

[0118] The storage can include any one or combination of volatile memory elements (e.g., random access memory (RAM) such as dynamic random access memory (DRAM), static random access memory (SRAM)) and non-volatile memory elements (e.g., read only memory (ROM), erasable programmable read only memory (EPROM), electronically erasable programmable read only memory (EEPROM), programmableread only memory (PROM), tape, compact disc read only memory (CD-ROM), etc.). The respective storage may incorporate electronic, magnetic, optical and / or other types of storage media. Furthermore, the respective storage can have a distributed architecture, where various components are situated remote from one another, but can be accessed by the processing means. For example, the ROM may store various instructions, programs, software, or applications to be executed by the processing means to control the operation of the system 110 and the RAM may temporarily store variables or results of the operations.

[0119] The use and operation of computers using software applications is well- known to persons skilled in the art and need not be described in any further detail herein except as is relevant to the present invention.

[0120] Furthermore, any suitable communication protocol can be used to facilitate connection and communication between any subsystems or components of the device 24, and other devices or systems, including wired and wireless, as are well known to persons skilled in the art and need not be described in any further detail herein except as is relevant to the present invention.

[0121] Where the words “store”, “hold” and “save” or similar words are used in the context of the present invention, they are to be understood as including reference to the retaining or holding of data or information both permanently and / or temporarily in the storage means, device or medium for later retrieval, and momentarily or instantaneously, for example as part of a processing operation being performed.

[0122] Additionally, where the terms “system”, “device”, and “machine” are used in the context of the present invention, they are to be understood as including reference to any group of functionally related or interacting, interrelated, interdependent or associated components or elements that may be located in proximity to, separate from, integrated with, or discrete from, each other.

[0123] Furthermore, in embodiments of the invention, the word “determining” is understood to include receiving or accessing the relevant data or information.

[0124] The mobile communication device 44 comprises a display 48 for displaying a user interface, and is operable to communicate via the user interface.

[0125] In the embodiment of the invention, the display 48 and the user interface are integrated in a touchscreen 50. In alternative embodiments these components may be provided as discrete elements or items.

[0126] The touchscreen 50 is operable to sense or detect the presence and location of a touch within a display area of the mobile communication device 44. Sensed “touchings” of the touchscreen 48 (by the operator 46, for example) are inputted to the mobile communication device 44 as commands or instructions and communicated to the controller 30 of the device 24. It should be appreciated that user input means is not limited to comprising a touchscreen, and in alternative embodiments of the invention any appropriate device, system or machine for receiving input, commands or instructions and providing for controlled interaction may be used, including, for example, a keypad or keyboard, a pointing device, or composite device, and systems comprising voice activation.

[0127] The controller 30 is operable, via execution of applications such as the app, to collect and process inputs pertinent to the output to be generated, including operating commands input by the operator 46 via the user interface.

[0128] Such operating commands include selection and uploading of stimulation protocols to the device 24. This advantageously allows for the use of pre-set protocols to, for example, optimise brain stimulation. Customised protocols (prescribed by a suitably qualified and experienced clinician, for example) and sham protocols may also be uploaded, advantageously facilitating ongoing research with the device 24. The user interface is also operable to display protocol uploads and provide feedback during sessions of use, enhancing user engagement and monitoring.

[0129] The device 24 comprises operably connected / coupled components facilitating performance and operations as described, including appropriate computer chips (integrated circuits), transceiver / receiver antennas, and software for the technology being used.

[0130] The headset 18 comprises a first, or circumferential, headband 52 adapted to fit circumferentially around and abut the head 16 of the wearer 12 when worn.

[0131] A second, or top, headband 54 is movably coupled to the circumferentialheadband 52 so as to be moveable between a plurality of operating positions.

[0132] In the embodiment, the coupling allows for movement of the top headband 54 in a first, or horizontal direction relative to the circumferential headband 52, in a second, or vertical direction relative to the circumferential headband 52, and in a third, or rotational direction, relative to the circumferential headband 52. It should be appreciated that the invention is not limited in this regard, and in alternative embodiments of the invention, additional, and / or alternative, movements between components or portions of the headgear 10 may be provided.

[0133] The top headband 52 may be seen to be, and function as, a rotatable, adjustable arm.

[0134] The coupling between the top headband 54 and the circumferential headband 52 in the embodiment will be described in further detail with reference to Figures 1 to 7B, 16, 17, and 19 of the drawings.

[0135] The circumferential headband 52 comprises a front portion 56, a rear portion 58 (opposite the front portion 56), and opposed side portions 60 (respectively extending between the front portion 56 and the rear portion 58), so as to be able to ‘encircle’ the head 16 when worn.

[0136] A front housing 62 is provided forwardly facing on the front portion 56.

[0137] A rear housing 64 is provided rearwardly facing on the rear portion 58. An adjustment means, implemented by a ratchet mechanism 66, is provided in the rear housing 64, and operable to allow for the circumference, or ‘encirclement’, of the circumferential headband 52 to be adjusted to fit different head 16 dimensions (i.e. for different wearers 12). Accordingly, the rear housing 64 may be referred to as a ratchet housing. Particularly, operation of a ratchet tightening dial 67 of the ratchet mechanism 66 in a first, or loosening direction, facilitates loosening (or increasing of the circumference of) the circumferential headband 52 for fitting a larger head 16. And operation of the ratchet tightening dial 67 of the ratchet mechanism 66 in a second, or tightening direction, facilitates tightening (or decreasing of the circumference of) the circumferential headband 52 for fitting a smaller head 16. In this way, an appropriately tight fit of the headgear 10 to the head 16 may be made. It may be appreciated that thiscomprises movement of the headgear 10 in a fourth, or circumferential, direction, as the internal circumference of the headband 52 is increased or decreased by operation of the ratchet tightening dial 67. This may be seen to operate as a tensioning or adjustable tightening system incorporated into the headset 18, advantageously enabling users to adjust the fit to their individual head size, ensuring both comfort and stability during use of the headgear 10, even when performing physical activity such as sport.

[0138] When worn, the rear portion 58 (or back) of the headgear 10 should be placed over the inion (the lump on the back of the head 16 corresponding to the external occipital protuberance) of the skull, and the front portion 56 (or front) of the headgear 10 should be placed at the level of the eyebrows of the wearer 12. The shaping of the headgear 10 is such that the front portion 56 (or front) is offset or raised relative to the rear portion 58 (or back) to facilitate this. The headgear 10 is specifically designed, shaped, and dimensioned to satisfy a criteria comprising, in the embodiment, a specification or condition relating to the position or placement of each of the more than one item 14 (electrodes 20, 22 in the embodiment) relative to the head 16. In the embodiment, the specification comprises the 10-20 system for EEG electrode positioning (depicted in Figures 18A and 18B of the drawings).

[0139] Furthermore, there is a relationship between components (moveable portions) of the headgear 10 such that when movement of the components (and item 14 thereupon) occurs, the criteria remains satisfied. In the embodiment, this relationship comprises a ratio used between these two points (i.e. the rear portion 58 and the front portion 56) to position electrodes 20, 22 to accurately target specific brain regions according to the specification. When the ratchet tightening dial 67 is operated to change size of the headset 18, the ratio is preserved, advantageously allowing the headset 18 to be easily fitted to the head 16 with accurate electrode placement each time without the need for difficult and time consuming manual measurements. It should be appreciated that the invention is not limited in this regard, and in alternative embodiments, alternative and / or additional criteria, specifications, and conditions, may be satisfied by the headgear 10, having additional and / or alternative relationships.

[0140] For example, in embodiments of the invention, midline targets along the nasion-inion arc may be established at fixed fractional distances, such as Fpz ~10%, Fz ~30%, Cz ~50%, Pz ~70%, Oz ~90%, with the headgear being operable to maintainthese fractional distances as the circumference is adjusted. Prefrontal targets F3 / F4 may then be located at the same antero-posterior level as Fz (~30%). Lateral offsets (motor cortex and prefrontal) may be determined using the standard preauricular ear-to- ear circumferential measure of the 10-20 system. This advantageously allows the ability, in embodiments, to use the headset without having to measure electrode positioning.

[0141] In adhering to the 10-20 system for EEG electrode positioning, precise targeting of specific brain regions for stimulation, such as multiple positions on the motor cortex and the dorsolateral prefrontal cortex, for example, is advantageously provided.

[0142] The construction of the headgear 10 advantageously facilitates easy application and adjustment on the head 16 and ensuring comfortable fit.

[0143] As will be described in further detail, the rotatable, adjustable arm implemented by the top headband 54 sits or is placed at a specific position on the head 16 base to target the motor cortex of the brain of the wearer 12, in the embodiment. This position is based on the specific ratio between differing parts of the skull of the head 12, with this ratio consistently maintained by the tensioning system around the head 16 implemented by the circumferential headband 52 and a tensioning system (to be described in further detail below) within the adjustable arm implemented by the top headband 54 to optimise electrode placement without the need for tedious measurements with every application. Based on these ratios, the adjustable arm implemented by the top headband 54 can then be rotated forward to specifically target the dorsolateral prefrontal cortex of the brain, for example.

[0144] The rear housing 64 also comprises a connection 68 for operably connecting the device 24 to the headset 18. In this regard, it should be appreciated that, whilst in the described embodiment the device 24 is separate and discrete, being removable from the headset 18, the invention is not limited in this regard. In alternative embodiments the device 24 may be integrated with the headset 18. The same may be said for the electrodes 20 and 22.

[0145] Having the device 24 removeable from the headset 18 in the embodiment advantageously facilitates charging of source 36 (for example via an external chargingdock or station 69) as depicted in Figures 13A and 13B of the drawings.

[0146] The tensioning or adjustable tightening system incorporated into the headset 18 by the top headband 54 will now be described in further detail. The top headband 54 comprises a middle portion 70 connecting and extending between opposed end portions 72. At each end portion 72 is provided an adjustment band upper 74 having an aperture in the form of a track 76 extending along the adjustment band upper 76.

[0147] A corresponding adjustment band lower 78 is slidably connected to each end portion 72 by means a protrusion in the form of a slider 80 slidably received within the track 76 of the respective adjustment band upper 76. The slider 80 works with friction within the track 76 between the two bands (of the adjustment band upper 74 and the adjustment band lower 78), to facilitate adjustable positioning of the top headband 54 in the vertical direction relative to the circumferential headband 52.

[0148] At an end of each adjustment band lower 78, opposite to and remote from the slider 80, is provided an aperture in the form of a hole 82 passing through the adjustment band lower 78, facilitating adjustable coupling to a respective side portion 60 of the circumferential headband 52, by a pin joint mechanism 84, as will be described in further detail.

[0149] At each side portion 60 of the circumferential headband 52 is provided an aperture in the form of a pin track 86 extending along the side portion 60.

[0150] The pin joint mechanism 84 comprises a headgear pin 88 passing from an inward side of the respective side portion 60, through the pin track 86, through a pivot ring 90 on an outward side of the respective side portion 60, through the hole 82 of the respective adjustment band lower 78, and operably connecting to a tightening dial 92. In the embodiment, the headgear pin 88 comprises a threaded pin that connects to the tightening dial 92 and is operable to clamp the rotational angle of the adjustment band lower 78.

[0151] The pin joint connection provided by the pin joint mechanism 84 facilitates rotational adjustable positioning of the top headband 54 relative to the circumferential headband 52. This may be seen to operate as a hinge mechanism that allows the top headband 54 to rotate forwardly, thereby accurately targeting the F3 and F4 frontalcortex positions of the brain of the wearer 12.

[0152] This functionality advantageously enables users to quickly and accurately stimulate the desired cortical regions without cumbersome setup procedures, whilst simultaneously stabilising the device 24. This aspect is particularly beneficial for athletes and patients engaged in physical activities, as it allows for uninterrupted performance of the desired activity whilst stimulation is occurring.

[0153] The pin track 86 is shaped to receive the pivot ring 90 in multiple positions, and particularly three set positions in the embodiment described. This facilitates adjustable positioning of the top headband 54 in the horizontal direction relative to the circumferential headband 52.

[0154] Mechanical tightening and loosening of the pin joint mechanism 84 is facilitated by the tightening dial 92. Particularly, operating or turning the tightening dial 92 in a first, or loosening direction, loosens the pin joint mechanism 84, increasing movement thereof until a loosen hard stop position is reached where no further loosening is possible. Allowing for the adjustment band lower 78 to be rotated about the headgear pin 88 (and hence the top headband 54 to be rotatably adjusted relative to the circumferential headband 52), and for the pivot ring 90 to be moved within the pin track 86 (and hence the top headband 54 to be horizontally adjusted relative to the circumferential headband 52).

[0155] Operating or turning the tightening dial 92 in a second, or tightening direction, tightens the pin joint mechanism 84, reducing movement thereof until a tightening hard stop position is reached where no further tightening is possible. Allowing the positioning of the top headband 54 to be fixed relative to the circumferential headband 52, once the desired adjustment has been made and the hard stop position is reached.

[0156] In an alternative embodiment of the invention, one or more components of the pin joint mechanism 84, such as the tightening dial 92, may be slimmer or more slimline, or otherwise shaped differently than depicted in the drawings, as indeed may other components of the headgear 10.

[0157] A padded cover 94 is provided on the inward face of the headgear pin 88, for wearer 12 comfort.

[0158] Referring to Figures 8 and 9, the front housing 62 has an inner 96 dimensioned and shaped to receive and hold electrode 20 and / or electrode 22 in an operating position according to a criteria. Two front positioning holes 98 are provided in the front housing inner 96 in this regard in the embodiment. It should be appreciated that the invention is not limited in this regard, and in alternative embodiments, holding of an item in alternative and / or additional operating positions, according to alternative and / or additional criteria, may be provided. An outer 100 of the front housing 62 is removable to facilitate access to the front housing inner 96 when required for an action, and re-attachable to cover and close the front housing 62 once the action requiring access has been completed.

[0159] Similarly, a top housing 102 is provided upwardly facing on the top headband 54. The top housing 102 has an inner 104 dimensioned and shaped to receive and hold electrode 20 and / or electrode 22 in an operating position according to a criteria. Three top positioning holes 106 are provided in the top housing inner 104 in this regard in the embodiment. It should be appreciated that the invention is not limited in this regard, and in alternative embodiments, holding of an item in alternative and / or additional operating positions, according to alternative and / or additional criteria, may be provided. An outer 108 of the top housing 102 is removable to facilitate access to the top housing inner 104 when required for an action, and re-attachable to cover and close the top housing 102 once the action requiring access has been completed.

[0160] The unique, inventive arrangement of the components of the headgear 10 facilitates precise stimulation of the relevant cortical areas of the brain of the wearer 12 without the need for complex head measurements.

[0161] In this regard, the top headband 54 may be seen to function as an electrode swivel arm, rotatably moveable from a first, or upright operating position to a second, or forward operating position, and therebetween. This adaptability to swivel between regions over the head 16 (and hence brain) of the wearer 12 advantageously ensures that anode / cathode electrode combinations can be placed in either the upright operating position or the forward position.

[0162] Referring to Figures 15A, 15B, and 15C, the three top positioning holes 106 provide three potential sites for electrode placement in the upright operating position. In the embodiment, the criteria for these potential sites for electrode placement are C4,Cz, and C3, which are correlated to the locations of the primary motor cortex of the brain (and commonly stimulated for the treatment of musculoskeletal conditions such as osteoarthritis). As mentioned, it should be appreciated that the invention is not limited in this regard, and in alternative embodiments, holding of an item in alternative and / or additional operating positions, according to alternative and / or additional criteria, may be provided.

[0163] The three top positioning holes 106 provide two potential sites for electrode placement in the forward operating position. Particularly, in the embodiment, the outer two sites (outer two top positioning holes 106) are utilised, but the central site (central top positioning hole 106), is not. In the embodiment, the criteria for these potential sites for electrode placement are F4 and F3 which are correlated to the locations of the left and right dorsolateral prefrontal cortex of the brain (and commonly stimulated for the treatment of psychiatric conditions such as depression / anxiety, for example).

[0164] In comparison with the moveable top headband 54, the front portion of the circumferential headband 52 may be seen to function as a fixed aspect of the headset 18. The two front positioning holes 98 provide two potential sites for electrode placement. In the embodiment, the criteria for these potential sites for electrode placement are for use as anodes / cathodes for stimulation elsewhere in the brain (that is, stimulation other than as provided by electrodes in the upright operating position and forward operating position).

[0165] In the embodiment, the electrodes 20 and 22 are able to be removed from the headgear 10 for cleaning and replacement as required. The front housing 62 (comprising the front housing inner 96 electrode holder and removable front housing outer 100 electrode cover) and top housing 102 (comprising the top housing inner 104 electrode holder and removable top housing outer 108 electrode cover) and electrodes are accordingly customised to facilitate easy placement and removal as required, whilst remaining sufficiently stabilised during use to allow the wearer 12 to perform physical activity, such as exercise or sport, for example, without interruption of current delivery from the device 24 to the electrodes 20 and / or 22 as appropriate.

[0166] In embodiments of the invention, the headgear 10 is connectable (or connected) to an other wearable for positioning an other item on an other part of the body of the wearer 12. Where provided, such a wearable may also comprises part of astimulation system.

[0167] In embodiment described, such an other wearable has the form of an armband 110 adapted to be worn on an arm (or shoulder) 112 of the wearer 12, as depicted in Figures 10, 11 , 12, 14A and 14B of the drawings.

[0168] The armband 110 comprises an arm strap 114 constructed from a soft material, and provided with a suitable hook-and-loop or other fastener, enabling it to be comfortably worn on the arm 112. The armband 110 comprises an armband housing 116 having an inner 118 dimensioned and shaped to receive and hold electrode 20 or electrode 22 in an operating position. One armband positioning hole 120 is provided in the armband inner 118 in this regard in the embodiment. It should be appreciated that the invention is not limited in this regard, and in alternative embodiments, additional and / or alternative wearables, holding of an additional and / or alternative item, in additional and / or operating positions relative to or for other body parts may be provided

[0169] An outer in the form of a cap 122 of the armband housing 116 is removable to facilitate access to the armband housing inner 118 when required for an action, and re-attachable to cover and close the armband housing 116 once the action requiring access has been completed.

[0170] An armband connector 124 is provided for operably connecting an electrode held in the armband 110 to the device 24 via the rear housing 64 of the headset 18.

[0171] The armband 110 advantageously allows an anode / cathode electrode to be placed on the arm 112 of the wearer 12. This is recommended for activation of the motor cortex given how deeply it sits within the brain. Figures 12, 14A and 14B show how current to the arm electrode is sent from the device 24 when the armband attachment provided by the connector 124 is inserted.

[0172] In an alternative embodiment, the armband housing may be clamped or otherwise held onto the arm strap by teeth or other suitable holding means.

[0173] In an embodiment, built-in safety features, such as impedance checks and stimulation limits, advantageously promote safe use.

[0174] The ratchet mechanism 66, provided in the rear housing 64 of thecircumferential headband 52, of the embodiment will be described in further detail with reference to Figures 21 to 26 of the drawings.

[0175] An inner housing 126 of the ratchet mechanism 66 also serves as an inner housing of the rear housing 64, and a forward facing portion thereof rests against the head 16 of the wearer 12 when worn. This forward facing portion may be provided with a padded cover for wearer 12 comfort.

[0176] A rearward facing portion of the inner housing 126 is configured to operably support, together with an outer housing 128 of the ratchet mechanism 66, a circular gear in the form of a pinion 130 in a working relationship with linear gears in the form of an upper rack 132 and a lower rack 134 provided on respective portions of the circumferential headband 52, thereby implementing a rack and pinion mechanism.

[0177] The outer housing 128 of the ratchet mechanism also serves as an outer housing of the rear housing 64.

[0178] The pinion 130 is operably connected to the ratchet tightening dial 67, so that operation or turning of the ratchet tightening dial 67 turns teeth of the pinion 130 against teeth of the upper rack 132 and / or the lower rack 134 accordingly, the movement adjusting the circumference or ‘encirclement’ of the circumferential headband 52. In the embodiment, this connection comprises a screw 138 covered by a removable screw cover 140.

[0179] In the embodiment, a dial spring 136 operably suspends the ratchet tightening dial 67 from the pinion 130 so that the pinion 130 gear only engages with the ratchet tightening dial 67 when the ratchet tightening dial is “pushed in” or otherwise moved against the dial spring 136 to be brought to an operating position. This advantageously prevents or mitigates accidental turning thereof (and consequently accidently undesirably adjusting the circumference, and hence fit, of the circumferential headband 52).

[0180] In an embodiment, a similar mechanism may be implemented for the top headband 54, and operable to allow for the top headband 54 to be adjusted (by similar tightening and loosening) to fit different head 16 dimensions for different wearers 12 too.

[0181] Particular features, operations, and capabilities of the headgear 10 will now be described in further detail, with particular reference to operation and use thereof.

[0182] A first, or initial, step comprises consultation and protocol set up. In this step a user, such as wearer 12, undergoes a consultation with a suitably qualified and experienced person, such as operator 46, to determine a plan comprising a suitable protocol, for treatment of a condition of the wearer, for example. The device 24 (electronic module) of the headgear 10) is then paired (or otherwise has communication established) with a remote device 42 (which, as mentioned may be a smartphone, tablet, or computer, for example), such as the mobile communication device 42, and the determined protocol is selected (chosen) and uploaded via Bluetooth wireless technology communication to the device 24.

[0183] A next step comprises headgear 10 preparation and application.

[0184] This comprises electrode saturation where, before fitting, the electrodes 20, 22 are saturated with the appropriate volume of saline solution to ensure conductivity through hair and scalp of the head 16 of the wearer 12.

[0185] It also comprises fitting of the headgear 10 to the head 16 of the wearer 12. The wearable headgear 10 is fitted to the head 10 with electrodes 20, 22 positioned according to the determined treatment plan and protocol to be applied. It may also comprise fitting of the armband 110 to the arm 112 (upper arm or shoulder) of the wearer 12, for, for example, extracephalic cathode (electrode) placement, if necessary or appropriate according to the determined treatment plan and protocol.

[0186] Once fitted, session execution occurs. This comprises a step of starting the protocol and initiating a session of operation of the headgear 10 (and attached device 24) to provide stimulation of the brain of the wearer 12.

[0187] Particularly, in the embodiment, the session is initiated by the operator 46 (or the wearer 12, as appropriate) pressing an activation button provided on the device 24, or via the app. During stimulation, users may engage in rehabilitation exercises, or other activities according to the treatment plan and protocol as advised (by the operator 46 and or other persons such as a clinician, or specialist, for example).

[0188] In the embodiment, monitoring is conducted during the session. In this regard, progress through the protocol, successful completion of stages thereof, and any errors in operation that may arise, are monitored via the app, advantageously providing real-time feedback to both the user (wearer 12) and clinician (operator 46).

[0189] Following completion of the session, post-session procedures or steps are undertaken. These comprise cleaning and storage. Particularly, after the session, the headgear 10 (and armband 110 if used) are removed from the wearer 12. Then, the device 24 and electrodes 20, 22 are disconnected and removed. Parts that have come into contact with skin (or hair) of the wearer 12 are cleaned or disposed of, as appropriate, ensuring hygiene and readiness for the next session.

[0190] From the preceding description, it can be appreciated that in the embodiment of the invention, the headgear 10 comprises the circumferential headband 52, the top headband 54 coupled to the circumferential headband 52, which is adjustable in vertical and rotational degrees of freedom, and one or more electrode housings (such as the front housing 62) at predefined locations on at least one of the headbands, wherein the headgear 10 includes a ratio-preserving constraint configured, such that, when the headgear 10 is tightened or loosened to fit different head sizes, the relative positions of the electrode housings remain at fixed fractional distances that correspond to the International 10-20 scalp locations, thereby advantageously enabling placement at motor cortex sites (for example, C3 / Cz / C4) and, by rotation of the top headband 54, prefrontal sites (for example, F3 / F4) without re-measuring the head 16 of the wearer 12.

[0191] The described embodiment of the headgear 10 comprises: the circumferential headband 52 adapted to fit circumferentially around and abut the head 16 of the wearer 12 when worn; the top headband 54 coupled to the circumferential headband 52 so as to be adjustable vertically and rotationally; the adjustment means for adjusting fit of the headgear 10 to the wearer’s 12 head 16; and at least one electrode housing (such as the front housing 62) at a location on at least one of the circumferential headband 52 or the top headband 54, the at least one electrode housing for housing an electrode (such as the electrode 20) of a stimulator for providing a stimulation output via the electrode, the location according to a specification relating to position of the electrode relative to the head 16, wherein the specification comprises the 10-20 system for electroencephalogram (EEG) electrode positioning, a ratio betweenthe circumferential headband 52 and the top headband 54 preserved during fit adjustment of the headgear 10 via the adjustment means so that the relative position of the electrode housing remains satisfying the 10-20 system for EEG electrode positioning.

[0192] It will be appreciated that the described embodiment of the invention provides several advantages as highlighted and described earlier herein. Additional advantages of the embodiment of the invention include:

[0193] Versatile Stimulation Modes: The integration of tDCS, tRNS, and tACS in a single device using fundamentally the same setup advantageously offers broad applications beyond traditional stimulation methods.

[0194] User-Centric Design: The ease of use, facilitated by clear LED feedback, app integration, and simple control mechanisms, empowers users for both supervised and independent application, advantageously broadening access to brain stimulation therapies.

[0195] Advanced Electrode System: The detailed design of the electrodes, focusing on effective stimulation and user comfort through optimal material use / design / placement and saline solution preparation, advantageously allows for non-invasive brain stimulation.

[0196] Efficacy: The meticulous design, emphasising ease of use and comfort, advantageously makes effective brain stimulation accessible and practical for a wider audience than traditionally.

[0197] The embodiment of the invention has three substantial advantages on all existing non-invasive brain stimulation devices, as follows.

[0198] Ability to be used with intensive physical activity. The tensioning system of the headgear 10 advantageously allows for it to be used even with or during intensive physical activity. As described, both the horizontal circumferential headband 52 and moveable arm implemented by the top headband 54 are adjustable to ensure a tight, snug fit, that will not loosen or move, or will at least reduce or mitigate loosening and movement, with intensive physical activity. This means that populations previouslyunable to use tDCS technology (e.g., athletes) now have the capacity to access this technology with embodiments of the invention.

[0199] Ability to be used without having to measure electrode positioning.

[0200] Existing devices require the wearer’s head to be measured, in accordance with the 10-20 electrode positioning system, to ensure the electrode(s) are positioned over the correct area of the brain. In the described embodiment of the invention, this is no longer necessary or required as the measurements are standardised based on a fixed ratio system when the headset 18 is fitted with the back section (rear portion 58) placed against the Inion of the skull, and the front section (front portion 56) placed at the level of the eyebrows of the wearer. This advantageously facilitates independent use and use in a home / unsupervised environment, for example, rather than a clinical or laboratory setting, previously not feasible with prior existing devices due to the tedious process of measuring and fitting electrodes to specific scalp locations on the wearer’s head.

[0201] In-built capacity to use an anode / cathode electrode on the upper arm of the wearer.

[0202] The embodiment of the invention has an in-built capacity to run an anode / cathode electrode to the upper arm of the wearer. This advantageously provides for proper stimulation of the motor cortex of the wearer’s brain.

[0203] User-friendly design.

[0204] Integration with a smartphone app for protocol selection and monitoring, combined with LED and audio feedback for operational status, advantageously allows for the embodiment of the invention to be user-friendly and accessible for both clinicians and patients, compared with prior existing devices which typically have complex setups and / or lack intuitive feedback mechanisms.

[0205] Advanced electrode and electrode housing design. The optimised electrode design of the embodiment of the invention advantageously provides for wearer comfort, effective stimulation, and reducing or minimising edge effects, advantageously leading to improved patient compliance and reduced side effects, a common concern with priorexisting brain stimulation devices.

[0206] It can be appreciated that the embodiment of the invention represents a significant advancement in the field of tDCS implementation. By combining ease of setup with the ability to be comfortably used by individuals engaged in athletic pursuits, the headgear 10 provides an inventive solution to the limitations of existing tDCS systems. This unique combination of features positions the headgear according to embodiments of the invention as a groundbreaking tool in the enhancement of athletic performance and the facilitation of rehabilitation processes.

[0207] Potential applications of embodiments of the invention include musculoskeletal injury rehabilitation, treating chronic pain, treating osteoarthritis, potential use in mental health conditions, potential use in improving motor learning / skill acquisition and performance enhancement, improved strength acquisition, and improved wakefulness and attention.

[0208] It will be appreciated by those skilled in the art that variations and modifications to the invention described herein will be apparent without departing from the spirit and scope thereof. The variations and modifications as would be apparent to persons skilled in the art are deemed to fall within the broad scope and ambit of the invention as herein set forth.

[0209] The present application claims priority from Australian Provisional Patent Application No. 2024903538, the contents of which are incorporated herein by reference in their entirety.

Claims

CLAIMSThe claims defining the invention are as follows:1 . Headgear adjustable to position an item on a head of a wearer, so that, when worn, the position of the item relative to the head corresponds to a criteria.

2. Headgear according to claim 1 , adjustable to position more than one item on the head of the wearer, so that, when worn, the position of each of the more than one item relative to the head corresponds to a respective criteria.

3. Headgear according to claim 1 or 2, wherein the item comprises an output of a stimulator for providing a stimulation output, the headgear for providing stimulation of, or stimulating, the brain of the wearer.

4. Headgear according to claim 3, wherein the stimulator comprises a controller and storage storing electronic program instructions for controlling the controller, wherein the controller is operable, under control of the electronic program instructions, to generate and provide the stimulation output.

5. Headgear according to claim 3 or 4, wherein the stimulation output comprises an electrical current for stimulation, which may include one or more types of non-invasive brain stimulation, including: Transcranial Direct Current Stimulation (tDCS);Transcranial Random Noise Stimulation (tRNS); and Transcranial Alternating Current Stimulation (tACS).

6. Headgear according to any one of claims 3 to 5, wherein the item comprises an electrode of the stimulator.

7. Headgear according to any one of claims 3 to 6, wherein the item and / or the stimulator are: removably connectable to the headgear; or integrated with the headgear.

8. Headgear according to any one of the preceding claims, wherein the criteria comprises a specification or condition relating to the position or placement of the item relative to the head.

9. Headgear according to claim 8, wherein the specification comprises the 10-20 system for electroencephalogram (EEG) electrode positioning.

10. Headgear according to any one of the preceding claims, comprising a first headband adapted to fit circumferentially around and abut the head of the wearer when worn, and a second headband movably coupled to the first headband so as to be moveable between a plurality of operating positions.11 . Headgear according to claim 10, wherein the coupling allows for movement of the second headband in a first direction relative to the first headband, in a second direction relative to the first headband, and in a third direction relative to the first headband.

12. Headgear according to claim 11 , wherein the first direction comprises a horizontal direction, the second direction comprises a vertical direction, and the third direction comprises a rotational direction.

13. Headgear according to any one of the preceding claims, comprising a relationship between moveable portions of the headgear such that when movement of the moveable portions occurs, the criteria remains satisfied.

14. Headgear according to claim 13, wherein the relationship comprises a ratio between the moveable portions of the headgear.

15. Headgear according to any one of the preceding claims, connectable, or connected, to an other wearable for positioning an other item on an other part of the body of the wearer.

16. Headgear according to claim 15, wherein the other wearable comprises an armband.

17. A method comprising adjustably positioning an item on a head of a wearer, so that, when worn, the position of the item relative to the head corresponds to a criteria.

18. A method according to claim 17, comprising adjustably positioning more than one item on the head of the wearer, so that, when worn, the position of each of the more than one item relative to the head corresponds to a respective criteria, which may be the same or vary according to the item.

19. A method according to claim 17 or 18, wherein the item comprises an output of a stimulator for providing a stimulation output, the method for providing stimulation of, or stimulating, the brain of the wearer.

20. A method according to claim 19, wherein the stimulator comprises a controller and storage storing electronic program instructions for controlling the controller, wherein the method further comprises operating the controller, via the electronic program instructions, to generate and provide the stimulation output.

21. Headgear comprising: a circumferential headband adapted to fit circumferentially around and abut a head of a wearer when worn; a top headband coupled to the circumferential headband so as to be adjustable vertically and rotationally; an adjustment means for adjusting fit of the headgear to the wearer’s head; and at least one electrode housing at a location on at least one of the circumferential headband or the top headband, the at least one electrode housing for housing an electrode of a stimulator for providing a stimulation output via the electrode, the location according to a specification relating to position of the electrode relative to the head, wherein the specification comprises the 10-20 system for electroencephalogram (EEG) electrode positioning, a ratio between the circumferential headband and the top headband preserved during fit adjustment of the headgear via the adjustment means so that the relative position of the electrode housing remains satisfying the 10-20 system for EEG electrode positioning.

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