Method and system for providing sensory stimulation to the brain to treat post-traumatic stress disorder

Abstract

The present disclosure describes a method for providing sensory stimulation to a user with a neurological disorder, such as post-traumatic stress disorder. The method includes receiving a set of sensory stimulation instructions by a processor within a headset. The method also includes administering a therapeutically effective amount of the sensory stimulation, wherein the sensory stimulation alternates between a first sensory stimulus comprising simultaneously providing a left visual stimulation pattern to the user's left eye and a right auditory stimulation pattern to the right side of the head, and a second sensory stimulus comprising simultaneously providing a right visual stimulation pattern to the user's right eye and a left auditory stimulation pattern to the left side of the head. The first sensory stimulus and the second sensory stimulus comprise a first stimulation pattern, a second stimulation pattern, and a third stimulation pattern, respectively.

Description

[Technical Field]

[0001] (cross reference) This PCT international patent application claims the benefit of U.S. Application No. 18 / 102,587 (now published as U.S. Patent Application Publication No. 2023 / 0347103), filed January 27, 2023, and entitled "Methods and Systems for Providing Sensory Stimulation to a Brain to Treat Post-Traumatic Stress Disorder," which is a continuation-in-part of U.S. Application No. 17 / 005,047 (now U.S. Patent No. 11,679,231), filed August 27, 2020, and entitled "Methods and Systems for Providing Stimuli to the Brain," which is a continuation-in-part of U.S. Application No. 17 / 005,047 (now U.S. Patent No. 11,679,231), filed May 24, 2019, and entitled "Methods and Systems for Providing Stimuli to the Brain." This application is a continuation of U.S. Application No. 16 / 422,592 (now U.S. Patent No. 11,141,559), entitled "Methods and Systems for Providing Stimuli to the Brain," which is a continuation of U.S. Application No. 15 / 360,808 (now U.S. Patent No. 10,328,236), filed November 23, 2016, entitled "Methods and Systems for Providing Audio and Visual Stimuli to Treat Neurological Disorders." This application claims priority to U.S. Provisional Application No. 62 / 258,965, filed November 23, 2015, entitled "Methods and Systems for Providing Audio and Visual Stimuli to Treat Neurological Disorders," which claims the benefit of U.S. Application Nos. 18 / 102,587, 17 / 005,047, 16 / 422,592, and 15 / 360,808. All five of these applications are incorporated herein by reference as if reproduced in full below.

[0002] The present disclosure relates to medical devices, systems, and methods. In particular, the present disclosure relates to providing stimulation to a subject to treat various neurological disorders or illnesses, including post-traumatic stress disorder ("PTSD"), and / or to provide performance enhancement. [Background technology]

[0003] Sensory stimulation has been applied to treat a variety of disorders. For example, binaural beats have been applied to induce various mental states to promote sleep, relaxation, meditation, creativity, and other desirable mental states. A combination of auditory and visual stimulation has also been applied to promote such mental states. However, the application of such therapy is less than ideal in many situations. Devices that provide stimulation are large, expensive, generally unavailable, and below the clinical efficacy threshold for widespread use, typically helping only a portion of the population. Users may find such devices difficult to use in many situations, such as when trying to sleep in a bedroom or airplane cabin.

[0004] Medications and / or nutritional supplements are often used in place of sensory stimulation to treat various neurological disorders and illnesses. However, the use of such medications is less than ideal in many situations. Medications are often expensive, depend on patient compliance, and may require a prescription from a medical professional. Medications may only be effective for a small, less-than-ideal portion of the general population. The effectiveness of medications and nutritional supplements, such as melatonin and zolpidem (e.g., AMBIEN®) for treating insomnia, is questionable. Medications often have undesirable side effects. For example, some medications for treating insomnia can cause a lack of deep sleep in certain areas, which can increase mortality.

[0005] Nevertheless, PTSD is most often treated with psychotherapy or medication. However, a significant proportion of PTSD patients do not recover from the severity and frequency of traumatic flashbacks, nightmares, and / or hyperarousal, despite repeated attempts at psychotherapy and medication. The lack of recovery and deterioration of patient health, which often occurs when PTSD patients are treated with standard therapeutic approaches, is a persistent problem in the field of neurological disorder treatment. In fact, billions of dollars are spent annually in the United States to provide follow-up medication and psychotherapy treatment, as well as other pill-based treatment approaches, to patients with neurological disorders such as PTSD who do not respond positively to initial medication and psychotherapy treatment plans.

[0006] For at least these reasons, improved methods and systems for treating neurological disorders and other ailments are desirable to overcome at least some of the aforementioned challenges. Summary of the Invention

[0007] The present disclosure relates to medical devices and methods that can be used to provide stimulation to a subject to treat, for example, various neurological disorders or illnesses, where the provided stimulation can include one or more of auditory, visual, or tactile stimulation. Examples of neurological disorders that can be treated using the devices and methods include, but are not limited to, insomnia, PTSD, brain injury (including, but not limited to, traumatic brain injury (TBI), mild traumatic brain injury (mTBI), or oxygen deprivation damage to the brain due to stroke), stroke, depression, anxiety, mood disorders, personality disorders, eating disorders, psychotic disorders, and balance disorders. Alternatively, or in combination, the stimulation provided by the medical devices and methods described herein can provide cognitive benefits and / or enhancements, including, but not limited to, improvements in neuroplasticity, motor skills, coordination of muscle movements, reaction time, attention, energy, working memory, mood, and sense of well-being.

[0008] In one aspect, a method for providing sensory stimulation to a user is disclosed. The method includes alternating between a first sensory stimulation including simultaneously providing a left visual stimulation pattern to the user's left eye and a right auditory stimulation pattern to the right side of the user's head, and a second sensory stimulation including simultaneously providing a right visual stimulation pattern to the user's right eye and a left auditory stimulation pattern to the left side of the user's head. The first sensory stimulation and the second sensory stimulation each include a first stimulation pattern having a first pulse frequency, a second stimulation pattern having a second pulse frequency less than the first pulse frequency, and a third stimulation pattern having a third pulse frequency less than the second pulse frequency. One of the first pulse frequency, the second pulse frequency, or the third pulse frequency is between approximately 3.75 Hz and 4.25 Hz.

[0009] In another aspect, a device for providing stimuli to a user is disclosed. The device includes a frame configured to be worn on the user's head and a controller programmed to generate a plurality of inputs including a left light source input, a right light source input, a left auditory source input, and a right auditory source input. The device further includes a left light source configured to generate a left visual stimulus pattern based on the left light source input and a right light source configured to generate a right visual stimulus pattern based on the right light source input. The device further includes a left auditory source configured to generate a left auditory stimulus pattern based on the left auditory source input and a right auditory source configured to generate a right auditory stimulus pattern based on the right auditory source input. The controller is programmed to generate inputs that alternate between a first input including simultaneously generating the left light source input and the right auditory source input and a second input including simultaneously generating the right light source input and the left auditory source input. The first input and the second input each include a first stimulus pattern having a first pulse frequency, a second stimulus pattern having a second pulse frequency less than the first pulse frequency, and a third stimulus pattern having a third pulse frequency less than the second pulse frequency. One of the first pulse frequency, the second pulse frequency, and the third pulse frequency is 3.75 Hz to 4.25 Hz.

[0010] In yet another aspect, a method for treating a neurological disorder or disease or providing performance enhancement is disclosed. The method includes providing a headset worn by a user and providing sensory stimulation to the user from the headset. The sensory stimulation alternates between a first sensory stimulation including simultaneously providing a left visual stimulation pattern to the user's left eye and a right auditory stimulation pattern to the right side of the user's head, and a second sensory stimulation including simultaneously providing a right visual stimulation pattern to the user's right eye and a left auditory stimulation pattern to the left side of the head. The first sensory stimulation and the second sensory stimulation each include a first stimulation pattern having a first pulse frequency, a second stimulation pattern having a second pulse frequency less than the first pulse frequency, and a third stimulation pattern having a third pulse frequency less than the second pulse frequency. One of the first pulse frequency, the second pulse frequency, or the third pulse frequency is between 3.75 Hz and 4.25 Hz.

[0011] In another aspect, a method of treating a user with PTSD is disclosed. The method includes receiving a set of sensory stimulation instructions by a processor in a headset configured to be worn on the user's head. The method further includes administering a therapeutically effective amount of sensory stimulation to the user in response to receiving the set of sensory stimulation instructions. The sensory stimulation alternates between a first sensory stimulation including simultaneously providing a left visual stimulation pattern to the user's left eye and a right auditory stimulation pattern to the right side of the user's head, and a second sensory stimulation including simultaneously providing a right visual stimulation pattern to the user's right eye and a left auditory stimulation pattern to the left side of the user's head. The first sensory stimulation and the second sensory stimulation include a first stimulation pattern having a first pulse frequency, a second stimulation pattern having a second pulse frequency, and a third stimulation pattern having a third pulse frequency. The method further includes collecting a set of user data related to the administration of the therapeutically effective amount of sensory stimulation to the user.

[0012] In another aspect, a headset is disclosed that provides a therapeutically effective amount of sensory stimulation to a user. The headset includes a frame configured to be worn on the user's head. The headset also includes a processor configured to generate a plurality of inputs including a left light source input, a right light source input, a left auditory source input, and a right auditory source input. The headset also includes a left light source configured to generate a left visual stimulus pattern using the left light source input. The headset also includes a right light source configured to generate a right visual stimulus pattern using the right light source input. The headset also includes a left auditory source configured to generate a left auditory stimulus pattern using the left auditory source input. The headset also includes a right auditory source configured to generate a right auditory stimulus pattern using the right auditory source input. The processor is configured to administer a therapeutically effective amount of sensory stimulation to the user through the headset. The plurality of inputs alternates between a first input including simultaneously generating the left light source input and the right auditory source input and a second input including simultaneously generating the right light source input and the left auditory source input. The first input and the second input include a first stimulation pattern having a first pulse frequency, a second stimulation pattern having a second pulse frequency less than the first pulse frequency, and a third stimulation pattern having a third pulse frequency less than the second pulse frequency.

[0013] In another aspect, a system for treating a user with PTSD is disclosed. The system includes a headset configured to be worn on the user's head. The headset includes a frame, a left light source, a left auditory source, a right light source, and a right auditory source. The system also includes a processor communicatively coupled to the headset and a controller. The processor is configured to receive sensory stimuli from the controller and transmit the sensory stimuli to the headset. The sensory stimuli are transmitted in a therapeutically effective amount, and the sensory stimuli alternate between a first sensory stimulus including simultaneously providing a left visual stimulus pattern from the left light source to the user's left eye and a right auditory stimulus pattern from the right auditory source to the right side of the user's head, and a second sensory stimulus including simultaneously providing a right visual stimulus pattern from the right light source to the user's right eye and a left auditory stimulus pattern from the right auditory source to the left side of the user's head. The first sensory stimulus and the second sensory stimulus include a first stimulus pattern having a first pulse frequency, a second stimulus pattern having a second pulse frequency less than the first pulse frequency, and a third stimulus pattern having a third pulse frequency less than the second pulse frequency.

[0014] These features, together with various auxiliary provisions and features which will become apparent to those skilled in the art from the following detailed description, are achieved by the method and system for providing stimuli to a user of the present invention, embodiments of which are illustrated, by way of example only, with reference to the accompanying drawings. [Brief explanation of the drawings]

[0015] The present disclosure is best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawings are not necessarily to scale. On the contrary, the dimensions of the various features may be arbitrarily increased or reduced for clarity.

[0016] [Figure 1A] 1A and 1B illustrate schematic diagrams of therapeutic systems for providing therapeutic auditory, visual, and / or tactile stimuli in accordance with the principles of the present disclosure. [Figure 1B]1A and 1B illustrate schematic diagrams of therapeutic systems for providing therapeutic auditory, visual, and / or tactile stimuli in accordance with the principles of the present disclosure.

[0017] [Figure 2A] 1A and 1B in accordance with the principles of the present disclosure. FIG. [Figure 2B] 1A and 1B in accordance with the principles of the present disclosure. FIG.

[0018] [Figure 3A] 1 illustrates a schematic diagram of an exemplary therapeutic wearable headset or sleep mask according to many embodiments in accordance with the principles of the present disclosure.

[0019] [Figure 3B] 3B schematically illustrates a user wearing the therapeutic wearable headset and sleep mask of FIG. 3A in accordance with the principles of the present disclosure.

[0020] [Figure 4] 1A-1C schematically illustrate a flowchart of a therapeutic method for providing therapeutic auditory, visual, and / or tactile stimuli, according to some embodiments, in accordance with the principles of the present disclosure.

[0021] [Figure 5] 1 illustrates generally a flowchart of a therapeutic method for providing stimulation to the brain of a user with a neurological disorder or disease, in accordance with the principles of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0022] The following description relates to various embodiments of the present disclosure. Although one or more of these embodiments may be preferred, the disclosed embodiments should not be interpreted or used as limiting the scope of the present disclosure, including the claims. In addition, those skilled in the art will understand that the following description has a broad application, and the description of any embodiment is meant only as an example of that embodiment, and is not intended to imply that the scope of the present disclosure, including the claims, is limited to that embodiment.

[0023] 1A is a schematic diagram of a first embodiment of a therapy system 100. The therapy system 100 provides one or more outputs that a person wearing the therapy system may experience as auditory, visual, and / or tactile stimuli. Thus, in one embodiment, the therapy system may include a left light source 110L, a right light source 110R, a left vibration source 120L, a right vibration source 120R, and a controller 130 for independently controlling and coordinating the operation of the light sources and vibration sources. Thus, for example, the therapy system 100 may be positioned on a user's head such that the left light source 110L is positioned over the left eye to provide left visual stimuli, the right light source 110R is positioned over the right eye to provide right visual stimuli, the left vibration source 120L is positioned to provide left-ear auditory stimuli, and the right vibration source 120R is positioned to provide right-ear auditory stimuli.

[0024] In one embodiment, the left light source 110L and the right light source 110R may each include a light emitting diode, an incandescent light source with a wavelength filter, a fluorescent light source, a backlit LCD panel, or other light source configured to provide a user with light of a desired predetermined wavelength or range of wavelengths.

[0025] In another embodiment, left vibration source 120L and right vibration source 120R may each include earphones, small speakers, or other vibration sources capable of providing auditory stimuli to the user. In certain other embodiments, left vibration source 120L and right vibration source 120R may include bone conduction vibrators in the audible frequency range that provide vibrations to the user's skull that are perceived as auditory by the user's ears. Optionally, one or more of left vibration source 120L and right vibration source 120R may also generate vibrations that are perceived as tactile stimuli. Thus, for example, controller 130 may provide the bone conduction vibrator with a first signal that vibrates or oscillates at a first frequency that can be interpreted by the user as an auditory stimulus, and a second signal at a lower second frequency that can be interpreted by the user as a tactile sensation. In other words, the bone conduction vibrator may be adapted to provide both auditory and tactile stimuli to the user.

[0026] In certain embodiments, left vibration source 120L and right vibration source 120R provide output at one or more particular frequencies or frequency ranges and are turned on and off at stimulation frequencies. Thus, for example, the vibration sources may be programmed to provide output at an audio frequency of 256 Hz for a certain period of time, and then not provide output for the next period of time. Thus, the vibration sources are audio frequency and square wave generators.

[0027] 1B is a schematic diagram of a treatment system 100′ according to a second embodiment. The treatment system 100′ according to the second embodiment is generally similar to the treatment system 100 according to the first embodiment, except where explicitly stated otherwise. Specifically, the treatment system 100′ according to the second embodiment includes a left tactile stimulation source 121L and a right tactile stimulation source 121R, each of which can be individually controlled and can provide tactile stimulation to a user of the treatment system 100′ in cooperation with a controller 130.

[0028] 2A and 2B show schematic diagrams of the controller 130 of the treatment system 100 or 100′. As shown in FIG. 2A, the treatment system 100 or 100′ may optionally include an external control unit 130a that can wirelessly communicate with the wireless receiver / transmitter 130c of the controller 130 via a wireless connection 131a. The wireless connection 131a may include a Bluetooth connection, a Bluetooth LE connection (Bluetooth is a registered trademark), a Wi-Fi connection, a ZigBee connection, an infrared (IR) connection, a radio frequency (RF) connection, or an inaudible acoustic signal connection, etc. The external control unit 130a may include a custom-built electronic controller. In many embodiments, the external control unit 130a may include a user's personal computing device that can download and run custom computer applications or “apps” to operate the system 100 or 100′ and provide a treatment plan. For example, the personal computing device may include a personal computer, a personal laptop computer, a tablet computer, or a smartphone. The custom computer application or “app” may be a downloadable application or “app” from an application distribution platform. The application may include one or more treatment plans that a user may select for implementation by the treatment system 100 or 100′. In some embodiments, the application allows a user to provide feedback information regarding the effectiveness of the treatment regimen, which may be uploaded and collected by a central server that communicates with the application, and the treatment regimen may be improved or optimized based on the feedback from one or more users. Alternatively, or in combination, as shown in FIG. 2B, the system 100 or 100′ may further include an external control unit 130a, such as a custom-built controller, that may communicate with the controller 130 via a wired connection 131a, such as a USB, Fireline, or Lightning connection.

[0029] 3A illustrates one embodiment of a therapeutic system 100 that includes a therapeutic wearable headset or sleep mask 140 that integrates light sources, vibration sources, and optionally tactile sources into a single form factor for presentation to a user. Thus, for example, when a user wears the wearable headset or sleep mask 140 on their head, the left light source 110L is positioned over the left eye to provide left visual stimuli, the right light source 110R is positioned over the right eye to provide right visual stimuli, the left vibration source 120L is positioned to provide left auditory stimuli, and the right vibration source 120R is positioned to provide right auditory stimuli.

[0030] As described herein above, the left vibration source 120L and the right vibration source 120R may each include a bone conduction vibrator that can provide both auditory and tactile stimulation. Alternatively, the wearable headset or sleep mask 140 is a therapeutic system 100' that includes the left tactile stimulation source 121L and the right tactile stimulation source 121R, each of which may be individually controlled and interfaced with the controller 130, as described above with respect to FIG. 1B.

[0031] As described herein above, the therapeutic wearable headset or sleep mask 140 may operate with an external controller 130a (e.g., a smartphone) that communicates with the controller 130 via a wireless connection 131a. The user US may have the option to turn tactile stimulation on or off, for example. Figure 3B shows the user US wearing the therapeutic wearable headset or sleep mask 140.

[0032] FIG. 4 shows a flowchart of an exemplary therapeutic method 400 for providing therapeutic auditory, visual, and / or tactile stimuli. At step 410, a subject may be identified as having a neurological disorder or illness. Examples of neurological disorders include, but are not limited to, insomnia, PTSD, brain injury, such as injury to the brain due to oxygen deprivation, such as traumatic brain injury (TBI), mild traumatic brain injury (mTBI), or stroke, depression, anxiety, mood disorders, personality disorders, eating disorders, psychotic disorders, and balance disorders. Alternatively, a subject may be selected to undergo the therapeutic method 400 to assist the subject in napping or sleeping to improve mental and / or physical performance. At step 420, the subject may be provided with a therapeutic system or headwear, such as system 100 or 100′ described above. At step 430, the subject may wear the therapeutic system or headwear, such as a wearable headset or sleep mask 140. At step 440, headset 140 executes programming 450 contained in controller 130 to provide stimuli to the subject. The programming may simultaneously provide two or more of the auditory, video, and / or tactile stimuli provided to the subject by headset 140, thereby providing power to activate, for example, left light source 110L, right light source 110R, left vibration source 120L, and / or right vibration source 120R.

[0033] As described herein above, the left vibration source 120L and the right vibration source 120R may each include a bone conduction vibrator that can provide both auditory and tactile stimulation. Alternatively, the wearable headset or sleep mask 140 is a therapeutic system 100' that includes the left tactile stimulation source 121L and the right tactile stimulation source 121R, each of which may be individually controlled and interfaced with the controller 130, as described above with respect to FIG. 1B.

[0034] In certain embodiments, providing two or more of the auditory, video, and / or tactile stimuli simultaneously may provide an improved therapeutic effect compared to providing only one of the auditory, video, or tactile stimuli at a time. Thus, to provide an improved therapeutic effect, two or more auditory, video, and / or tactile stimuli can be combined (i.e., two or more auditory, video, and / or tactile stimuli can act synergistically to provide improved results over providing the two stimuli individually).

[0035] Exemplary instructions for providing stimuli may be provided by programming 450, such as subroutine 450a, which may include simultaneously activating all active auditory, video, and / or tactile stimulus sources. Optionally, activating all stimulus sources may include activating tactile stimuli to run through all subsequent auditory and / or visual stimuli. Another exemplary subroutine 450b may include alternating between left and right auditory, video, and / or tactile stimulus sources (i.e., left and right stimuli are alternately active). Another exemplary subroutine 450c may include alternating between visual and auditory and / or tactile sources (i.e., visual and auditory / tactile stimuli are alternately active). Another exemplary subroutine 450d may include alternating between an auditory and / or tactile source on the left side and a visual source on the right side, and an auditory and / or tactile source on the right side and a visual source on the left side (i.e., opposite auditory / tactile stimuli are alternately active). Such programming is described further below.

[0036] In step 440, each of the programming 450, including but not limited to subroutines 450a, 450b, 450c, and 450d, may be applied one or more times, individually, or in combination with one another. The programming may also provide sequences of outputs at different frequencies and / or timings in subroutines 450a, 450b, 450c, and 450d. Thus, for example, a subroutine may provide an output at a particular frequency that changes as the subroutine is repeated. Thus, for example, subroutine 450a may provide an auditory output to vibration source 120R or 120L at an on-off frequency of 256 Hz, i.e., pulsed for two minutes at a 1 Hz pulse frequency. This square wave auditory signal thus generates a signal at a 1 Hz frequency, in addition to harmonics. The 256 Hz output is then pulsed for two minutes at twice the previous pulse frequency. In this manner, the 256 Hz auditory frequency may be modulated over a wide range, including frequencies corresponding to brainwave frequencies.

[0037] Also, by alerting the output between the left and right channels, the brain can be stimulated to force communication between the left and right sides of the brain. This forced communication can connect, for example, PTSD memories to both sides of the brain, thereby stopping unwanted flashbacks.

[0038] While the above steps illustrate a method 400 for treating a patient according to an embodiment, one skilled in the art will recognize many variations based on the teachings provided herein. Steps may be completed in a different order. Steps may be added or deleted. Some steps may include sub-steps. Many steps may be repeated as frequently as is beneficial to the treatment.

[0039] One or more of the steps of method 400 may be performed using circuitry described herein, such as the circuitry of controller 130 or external control unit 130a, using one or more of a processor or logic circuitry, such as a central processing unit (CPU) or programmable array logic for a field programmable gate array. The circuitry may be programmed to provide one or more of the steps of method 400, and the program may include program instructions stored in a computer-readable memory or programmed steps of a logic circuitry, such as programmable array logic or a field programmable gate array.

[0040] 5 shows a flowchart of an exemplary therapeutic method 500 for providing therapeutic auditory, visual, and / or tactile stimuli to the brain of a user with a neurological disorder or disease. Auditory stimuli may include tones, beeps, songs, or any other desired form of sound presented audibly to the user. Visual stimuli may include flashes of white light, presentations of various colors, displays of visual images, or any other desired form of light visually presented to the user. Tactile stimuli may include vibrations, taps, air movement, or any other desired form of physical contact presented tactilely to the user.

[0041] In step 510, the headset 140, 130 may be provided to a user. The user may be a person diagnosed with or suspected of having a neurological disorder or illness. Examples of neurological disorders include, but are not limited to, PTSD.

[0042] The headset 140 provided in step 510 may be configured to provide auditory, visual, and / or tactile stimuli to the user's brain. For example, the headset 140 may include a frame, a processor, a left light source 110L, a right light source 110R, a left auditory or vibration source 120L, and a right auditory or vibration source 120R.

[0043] In some embodiments, headset 140 may include left and right tactile stimulation sources 121L and 121R, each of which may be individually controlled and associated with controller 130, as described above with respect to FIG. 1B.

[0044] The processor may generate a left light source input, a right light source input, a left auditory source input, and / or a right auditory source input using provided programming 450 (described in more detail below). The generated inputs are transmitted from the processor to controller 130, which is operatively coupled to hardware in headset 140 such that corresponding outputs are generated from left light source 110L, right light source 110R, left auditory source 120L, right auditory source 120R, or a combination thereof.

[0045] For example, if the processor includes instructions for providing a visual stimulus to a user's left eye, the processor may generate a left light source input. In some examples, generating the left light source input results in light being output from left light source 110L. Thus, as another example, if the processor includes instructions for providing a visual stimulus to a user's right eye, the processor may generate a right light source input. In some examples, generating the right light source input results in light being output from right light source 110R. Similarly, as one example, if the processor includes instructions for providing an auditory stimulus to a user's left ear, the processor may generate a left auditory source input. Generating the left auditory source input may result in sound being output from left auditory source 120L. As another example, if the processor includes instructions for providing an auditory stimulus to a user's right ear, the processor may generate a right auditory source input. Thus, generating the right auditory source input may result in sound being output from right auditory source 120R.

[0046] Left light source 110L can display a left visual stimulus pattern using the left light source input. Right light source 110R can display a right visual stimulus pattern using the right light source input. Left auditory source 120L can display a left auditory stimulus pattern using the left auditory source input. Right auditory source 120R can display a right auditory stimulus pattern based on the right auditory source input using the right auditory source input.

[0047] Additionally, when the processor receives instructions from controller 130 to provide haptic stimulation to the left side of the user's head, the processor can adjust the vibration output from left haptic source 121L. Similarly, when the processor executes instructions to provide haptic stimulation to the right side of the user's head, headset 140 can adjust the vibration output from right haptic source 121R.

[0048] In step 520, headset 140 may be coupled to the user's head. The coupling step 520 may be completed by placing the frame of headset 140 in place on the user's head. In some examples, the frame may be positioned on top of, above, or around the user's ears. In other examples, the frame may be positioned partially over the top of the user's head to be secured in a stable position around the user's head.

[0049] In step 530, the processor receives programming 450 having instructions for performing sensory stimulation via headset 140 to treat the user. Controller 130 may be used to transmit the sensory stimulation instructions to headset 140. The controller may be a control system operably coupled to the headset and capable of remotely controlling the functions of headset 140. Controller 130 may be any control system operable by a doctor, nurse, or therapist providing treatment to the user, or by any other desired person. For example, controller 130 may be a control system within one or more of a personal computer, laptop computer, tablet computer, smartphone, wearable computer, or any other desired computing system.

[0050] Programming 450 may include instructions for providing stimuli to the user. For example, programming 450 may include subroutine 450a including instructions for simultaneously activating all auditory, video, and / or tactile stimulus sources. Another exemplary programming 450 may include subroutine 450b including instructions for alternating between the left auditory, video, and / or tactile stimulus source and the right auditory, video, and / or tactile stimulus source, respectively (i.e., the left and right stimuli are alternately active and inactive). Another exemplary programming 450 may include subroutine 450c including alternating between the visual and auditory and / or tactile sources (i.e., the visual and auditory / tactile stimuli are alternately active and inactive). Further, by way of example, programming 450 may include subroutine 450d, which includes alternating between a left auditory and / or tactile source and a right visual source, and a right auditory and / or tactile source and a left visual source (i.e., the opposing auditory / tactile stimuli are alternately active and inactive). Programming 450 may include any desired combination of subroutines 450a, 450b, 450c, and 450d.

[0051] The processor of headset 140 may be operatively coupled to controller 130 to receive instructions for providing stimuli in the form of programming 450. For example, the processor may receive programming 450 from controller 130 and execute programming 450 using headset 140. In some embodiments, controller 130 may include a predetermined set of known programming for treating PTSD. In other embodiments, controller 130 may be programmed in real time or near real time based on the needs of the user. Programming 450 includes instructions for the processor to execute two or more of auditory, video, and / or tactile stimuli, which may be activated by headset 140 to the user in real time or near real time.

[0052] In step 540, in response to receiving the sensory stimulation, the headset 140 administers a therapeutically effective amount of sensory stimulation to the user. As described and disclosed herein, a therapeutically effective amount of sensory stimulation is an amount of stimulation that stimulates the user's brain to cause communication between the left and right sides of the brain. Thus, a "therapeutically effective amount" correlates with the amount of sensory stimulation that produces one or more desired effects, such as one or more therapeutic or other beneficial effects. A therapeutically effective amount of sensory stimulation may vary depending on factors such as neurological disorder, age, gender, the user's weight, any other factor, or a combination thereof. Providing a therapeutically effective amount of sensory stimulation to the user's brain causes the brain's left and right channels to output, causing the left and right sides of the brain to communicate with each other. This forced communication can, for example, connect PTSD memories to both sides of the brain. Connecting PTSD memories to both sides of the brain can reduce or completely eliminate sudden flashbacks of traumatic memories. Reducing the occurrence of traumatic memories may increase the user's ability to sleep through the night, thereby improving the user's vital health statistics, such as blood pressure, pulse rate, or any other vital health statistics. Additionally, providing therapeutically effective amounts of stimulation at different pulse frequencies may reduce flashbacks, nightmares, and hyperarousal in the user.

[0053] The headset 104 can administer a therapeutically effective amount of therapy through various auditory, visual, and / or tactile patterns. Specifically, a left visual stimulation pattern refers to a pattern that cycles between light and no light using the left light source 110L, a right visual stimulation pattern refers to a pattern that cycles between light and no light using the right light source 110R, a left auditory stimulation pattern refers to a pattern that cycles between silence and sound using the left auditory source 120L, a right auditory stimulation pattern refers to a pattern that cycles between silence and sound using the left auditory source 120R, a left tactile stimulation pattern refers to a pattern of vibration using the right tactile source 121L, a right tactile stimulation pattern refers to a pattern of vibration using the right tactile source 121R, any other desired pattern, or a combination thereof. Each of the various stimulation patterns can operate at a different pulse rate and frequency than the other stimulation patterns. In some embodiments, the stimulation patterns operate at the same frequency and / or pulse rate.

[0054] The sensory stimulation administered in step 540 may alternate between a first set of sensory stimulation instructions (known as the first sensory stimulation) and a second set of sensory stimulation instructions (known as the second sensory stimulation). For example, the first sensory stimulation may include simultaneously providing a left visual stimulation pattern to the user's left eye and a right auditory stimulation pattern to the right side of the user's head. In this example, the second sensory stimulation may include simultaneously providing a right visual stimulation pattern to the user's right eye and a left auditory stimulation pattern to the left side of the user's head.

[0055] The first and second sensory stimuli may include a first stimulation pattern having a first pulse frequency, a second stimulation pattern having a second pulse frequency, and a third stimulation pattern having a third pulse frequency. In some examples, one of the first pulse frequency, the second pulse frequency, or the third pulse frequency is greater than or equal to 3.75 Hz and less than or equal to 4.25 Hz. In other examples, the first pulse frequency is greater than or equal to 7.5 Hz and less than or equal to 8.5 Hz, the second pulse frequency is greater than or equal to 2.5 Hz and less than or equal to 3.5 Hz, and the third pulse frequency is greater than or equal to 0.5 Hz and less than or equal to 1.5 Hz.

[0056] As described herein above, left auditory source 120L, left tactile source 121L, right auditory source 120R, and right tactile source 121R may each include a bone conduction vibrator capable of providing both auditory and tactile stimuli.

[0057] In certain embodiments, headset 140 may provide two or more of the auditory, video, and / or tactile stimuli simultaneously, which may result in improved therapeutic effects compared to providing only one of the auditory, visual, or tactile stimuli at a time. Thus, to provide improved therapeutic effects, two or more auditory, video, and / or tactile stimuli may be combined (i.e., two or more auditory, video, and / or tactile stimuli may act synergistically to provide improved results over providing the two stimuli individually).

[0058] The administration of the sensory stimulus in step 540 may occur over a predetermined treatment period. As shown in Table 4 of Example 5 below, the predetermined treatment period (i.e., the amount of time the device is set to be used) may be approximately 5 hours. In another example, as shown in Table 4 of Example 5 below, the predetermined treatment period may be approximately 2 hours. The predetermined treatment period may be less than 2 hours, between 2 and 5 hours, or greater than 5 hours. The length of the predetermined treatment period may vary for each user's treatment session, or the predetermined treatment period may be a similar time interval for each treatment session. For example, as the user's health improves, the predetermined treatment period may decrease.

[0059] Finally, in step 550, after the headset 104 administers a therapeutically effective amount of sensory stimulation to the user, the headset 104 collects a set of user data. The set of user data may include data collected from data sensors present in or connected to the headset. The data sensors may collect user data including, for example, pulse rate, body temperature, respiratory rate, blood pressure, any other desired data, or a combination thereof. Additionally, the collected set of user data may include user-reported data including information regarding sleep schedule, frequency of PTSD-related memories or flashbacks, severity of PTSD-related memory flashbacks, anxiety, or a combination thereof.

[0060] Although the above are steps of a method 500 for treating a patient in accordance with one or more embodiments of the present disclosure, one of ordinary skill in the art will recognize many variations based on the teachings provided herein. Steps may be completed in a different order. Steps may be added or deleted. Some steps may include sub-steps. Many steps may be repeated as frequently as is beneficial to the treatment of the user.

[0061] One or more of the steps of method 500 may be performed using circuitry described herein, such as the circuitry of controller 130 or external control unit 130a, for example, a central processing unit (CPU) or logic circuitry such as programmable array logic for a field programmable gate array. The circuitry may be programmed to provide one or more of the steps of method 500, and the program may include program instructions stored in a computer-readable memory or programmed steps of a logic circuit such as programmable array logic or a field programmable gate array. [Example]

[0062] Below are described examples of stimulation patterns that have been found in empirical studies to be effective in inducing sleep, including naps; improving neuroplasticity; treating brain injury from stroke, TBI, or mTBI; improving balance, including improving fine motor control and reaction time; and treating PTSD.

[0063] The light and auditory stimuli may be provided at a first frequency for a first time segment, then at a lower second frequency for a second time segment, and then at a lower third frequency for a third time segment. Each time segment may include one or more subsegments of light and auditory stimuli, each subsegment including, for example, one of the subroutines described above. The light and auditory stimuli may end after a predetermined time interval, such as 20 minutes. The light and auditory stimuli may increase or decrease (i.e., starting at the third frequency, then transitioning to the second frequency, and finally transitioning back to the third frequency), such as to wake the user. Alternatively, or in combination, the light and auditory stimuli may be maintained at the second frequency, such as to maintain a sleep state in the user. As described above, tactile stimuli may be provided simultaneously with the auditory stimuli. The light may be provided at a wavelength of 580 nm, and the auditory stimuli may have a frequency of 256 Hz. Alternatively, any number of auditory frequencies or combinations thereof may be provided, selectable by the subject.

[0064] Table 1 below describes an exemplary treatment regimen for this embodiment. The stimuli provided in Table 1 consist of a cycle of one block of four segment A outputs, followed by a cycle of one block of four segment B outputs, followed by seven cycles of a block of four segment C outputs, and finally a repeat of the block of four segment A outputs. For segment A outputs (A1, A2, A3, and A4), the auditory and optical outputs are cycled on for 0.1277 seconds and then off for 0.1277 seconds (i.e., at a pulse frequency of 3.9 Hz) 115 or 116 times, followed by 0.5 seconds of no output. For segment B outputs (B1, B2, B3, and B4), the auditory and optical outputs are cycled on for 0.3333 seconds and then off for 0.3333 seconds (i.e., at a pulse frequency of 1.5 Hz) 44 or 45 times, followed by 0.5 seconds of no output. For segment C outputs (C1, C2, C3, and C4), the audio and light outputs cycle 14 or 15 times, one second on and one second off (i.e., at a 0.5 Hz pulse frequency), followed by one second of no output. Segments A1, B1, and C1, as provided by subroutine 450a, simultaneously pulse the right and left light and audio outputs, synchronized so that all outputs are on or off simultaneously. Segments A2, B2, and C2, as provided by subroutine 450b, synchronize the left and right light and audio outputs to be opposites of each other. Segments A3, B3, and C3, as provided by subroutine 450c, synchronize both lights to be opposites of both audio outputs. Segments A4, B4, and C4, as provided by subroutine 450d, synchronize the right audio and light outputs to be opposites of the left audio and light outputs. [Table 1] JPEG2026505762000003.jpg255161JPEG2026505762000004.jpg119170 [Example]

[0065] The following describes examples of stimulation patterns that have been found to be effective in inducing sleep through empirical studies. The stimulation pattern of Example 2 includes a portion of the treatment regimen shown in Table 1. Specifically, the stimulation first cycles one block of four Segment A outputs, then cycles one block of four Segment B outputs, and then cycles seven blocks of four Segment C outputs. The repetition of the final block of four Segment A outputs is not provided in Example 2. [Example]

[0066] Below are described examples of stimulation patterns that have been found in empirical studies to be effective in increasing alpha wave brain activity, inducing neuroplasticity, and in treating stroke or other brain injuries such as TBI, mTBI, including improving balance, fine motor control, and reaction time, as well as treating PTSD.

[0067] In this example, the four subroutines described above and herein are each applied and repeated over multiple time segments at a predetermined stimulation (repetition) frequency. The four subroutines may be repeated, for example, such that each segment of the four subroutines lasts 120 seconds. As noted above, tactile stimulation may be provided simultaneously with auditory stimulation. Light may be provided at a wavelength of 580 nm, and auditory stimulation having a frequency of 432 Hz may be provided.

[0068] Table 2 below describes an exemplary treatment regimen for this embodiment. The stimuli provided in Table 2 cycle through blocks of four segment A outputs 10 times. For segments A1, A2, A3, and A4, the audio and light outputs are cycled 115 or 116 times, being on for 0.1277 seconds and off for 0.1277 seconds, followed by 0.5 seconds of no output. Segment A1, as provided by subroutine 450a, simultaneously pulses the right and left light and audio outputs, synchronized so that all outputs are on or off simultaneously. Segment A2, as provided by subroutine 450b, synchronizes the left and right light and audio outputs to be opposite each other. Segment A3, as provided by subroutine 450c, synchronizes both lights to be opposite both audio outputs. Segment A4, as provided by subroutine 450d, synchronizes the right audio and light outputs to be opposite the left audio and light outputs. [Table 2] [Example]

[0069] The following describes another example of a stimulation pattern that has been found in empirical studies to be effective in improving a subject's energy levels. Light and auditory stimuli may be provided at a first frequency for a first time segment, then at a second, higher frequency for a second time segment, and then again at the first frequency for a subsequent time segment. Each time segment may include one or more subsegments of light and auditory stimuli, each subsegment including, for example, one of the subroutines described above. The light and auditory stimuli may terminate after a predetermined time interval, such as 20 minutes. As described above, tactile stimuli may be provided simultaneously with the auditory stimuli. The light may be provided at a wavelength of 580 nm, and the auditory stimuli may have a frequency of 432 Hz.

[0070] Table 3 below describes an exemplary treatment regimen for this embodiment. The stimuli provided in Table 3 first cycle through a block of four segment A outputs 10 times, followed by one block of four segment D outputs. For segment A outputs (A1, A2, A3, and A4), the auditory and light outputs cycle on for 0.1277 seconds and then off for 0.1277 seconds 115 or 116 times, followed by 0.5 seconds of no output. For segment D outputs (D1, D2, D3, and D4), the auditory and light outputs cycle on for 0.0667 seconds and then off for 0.0667 seconds 44 or 45 times, followed by 0.5 seconds of no output. Segments A1 and D1, as provided by subroutine 450a, pulse the right and left optical and auditory outputs simultaneously, synchronized so that all outputs are turned on or off simultaneously. Segments A2 and D2 synchronize the left and right light and audio outputs to be opposite to each other, as provided by subroutine 450b. Segments A3 and D3 synchronize both lights to be opposite to both audio outputs, as provided by subroutine 450c. Segments A4 and D4 synchronize the right audio and light to be opposite to the left audio and light outputs, as provided by subroutine 450d. [Table 3] JPEG2026505762000007.jpg80170 [Example]

[0071] Table 4 below lists experimental results relating to the use of the method of the present invention. The table lists the subject of the test or treatment, details of the disease, number of subjects, and results of the test. In each case, the stimulation in Example 1 and the stimulation in Example 2 for treating non-sleep-related problems and inducing short sleep were used for all other treatments.

[0072] Some treatments have improved physical and / or mental abilities, such as fine motor control and reaction time. This may be due to the devices improving neuroplasticity in the days following treatment. Other treatments may improve work performance, reverse brain damage such as damage caused by oxygen deprivation (stroke), improve balance, and improve fine motor control in individuals suffering from traumatic brain injury (TBI) or mild traumatic brain injury. Other treatments have helped individuals suffering from PTSD by reducing the subject's response to triggering stimuli. [Table 4] JPEG2026505762000009.jpg255165JPEG2026505762000010.jpg213170 (example embodiment)

[0073] The following is an exemplary embodiment.

[0074] Exemplary embodiment 1 includes a method of providing stimuli to a user, the method including the steps of providing a headset to be worn by a user, applying a left visual stimulation pattern to the user's left eye by the headset, applying a right visual stimulation pattern to the user's right eye by the headset, applying a left auditory stimulation pattern to the left side of the user's head by the headset, and applying a right auditory stimulation pattern to the right side of the head by the headset, wherein the application of the left visual stimulation pattern, the application of the right visual stimulation pattern, the application of the left auditory stimulation pattern, and the application of the right auditory stimulation pattern are coordinated with each other.

[0075] In exemplary embodiment 2, which includes exemplary embodiment 1, applying a left auditory stimulation pattern through the headset includes applying a left tactile stimulation pattern through the headset, and applying a right auditory stimulation pattern through the headset includes applying a right tactile stimulation pattern through the headset.

[0076] In exemplary embodiment 3, which includes exemplary embodiment 2, the left and right tactile stimulation patterns are configured to generate multiple concurrent left and right tactile signals.

[0077] In exemplary embodiment 4, which includes exemplary embodiment 2, the left and right tactile stimulation patterns are configured to generate a plurality of alternating left and right tactile signals.

[0078] In exemplary embodiment 5, which includes exemplary embodiment 2, the left tactile stimulation pattern is coordinated with the left auditory stimulation pattern, and the right tactile stimulation pattern is coordinated with the right auditory stimulation pattern.

[0079] In exemplary embodiment 6, which includes exemplary embodiment 5, the left tactile stimulation pattern includes a left-side vibration of a first frequency generated simultaneously with hearing during the left auditory stimulation pattern, and the right tactile stimulation pattern includes a right-side vibration of a second frequency generated simultaneously with hearing during the right auditory stimulation pattern.

[0080] In exemplary embodiment 7, which includes exemplary embodiment 6, one or more of the left vibration or the right vibration is a vibration of 0.5 Hz to 1.5 Hz.

[0081] In exemplary embodiment 8, which includes any one of exemplary embodiments 1 to 7, applying the left auditory stimulation pattern via the headset includes generating a left tactile stimulation pattern via a left bone conduction vibrator of the headset, and applying the right auditory stimulation pattern via the headset includes generating a left tactile stimulation pattern via a left bone conduction vibrator of the headset.

[0082] In exemplary embodiment 9, which includes any one of exemplary embodiments 1-7, the left visual stimulation pattern and the right visual stimulation pattern are configured to generate multiple concurrent left and right optical signals.

[0083] In exemplary embodiment 10, which includes any one of exemplary embodiments 1-7, the left visual stimulation pattern and the right visual stimulation pattern are configured to generate a plurality of alternating left and right optical signals.

[0084] In exemplary embodiment 11, which includes any one of exemplary embodiments 1-7, the left auditory stimulation pattern and the right auditory stimulation pattern are configured to generate multiple concurrent left and right auditory signals.

[0085] In exemplary embodiment 12, which includes any one of exemplary embodiments 1-7, the left and right auditory stimulation patterns are configured to generate a plurality of alternating left and right auditory signals.

[0086] In exemplary embodiment 13, which includes any one of exemplary embodiments 1 to 12, one or more of the left visual stimulation pattern or the right visual stimulation pattern has a light wavelength of 550 nm to 610 nm.

[0087] In exemplary embodiment 14, which includes any one of exemplary embodiments 1 to 13, one or more of the left visual stimulation pattern or the right visual stimulation pattern has a light wavelength of 580 nm.

[0088] In exemplary embodiment 15, which includes any one of exemplary embodiments 1-14, one or more of the left auditory stimulation pattern or the right auditory stimulation pattern has an auditory frequency between 240 Hz and 480 Hz.

[0089] In exemplary embodiment 16, which includes any one of exemplary embodiments 1-15, one or more of the left auditory stimulation pattern or the right auditory stimulation pattern has an auditory frequency of 256 Hz or 432 Hz.

[0090] In exemplary embodiment 17, which includes any one of exemplary embodiments 1-16, one or more of the left visual stimulation patterns include repeatedly pulsing light at one or more of a first frequency, a second frequency less than the first frequency, or a third frequency less than the first frequency and the second frequency.

[0091] In exemplary embodiment 18, which includes any one of exemplary embodiments 1-17, the first frequency is between 3.75 Hz and 4.25 Hz, the second frequency is between 1.25 Hz and 1.75 Hz, and the third frequency is between 0.25 Hz and 0.75 Hz.

[0092] In exemplary embodiment 19, including exemplary embodiment 19, the first frequency is 3.9 Hz, the second frequency is 1.5 Hz, and the third frequency is 1 Hz.

[0093] In exemplary embodiment 20, which includes exemplary embodiment 18 or 19, repeatedly pulsing the light includes pulsing the light at time intervals.

[0094] In exemplary embodiment 21, which includes exemplary embodiment 20, the predetermined time interval is 25 to 35 seconds.

[0095] In exemplary embodiment 22, which includes exemplary embodiment 20 or 21, the predetermined time interval is 30 seconds.

[0096] In exemplary embodiment 23, which includes any one of exemplary embodiments 1-22, one or more of the left auditory stimulation pattern or the right auditory stimulation pattern includes a sequence of stimulation patterns, each having a pulse frequency and a pulse period, and the repetitive time signal includes a portion of the pulse period and includes an auditory frequency of 240 Hz to 480 Hz and a portion of the pulse period.

[0097] In exemplary embodiment 24, including exemplary embodiment 23, the portion of the pulse period is half a pulse period.

[0098] In exemplary embodiment 25, which includes exemplary embodiment 23 or 24, the sequence of stimulation patterns includes a first stimulation pattern having a first pulse frequency, a second stimulation pattern having a second pulse frequency that is less than the first pulse frequency, and a third stimulation pattern having a third pulse frequency that is less than the second pulse frequency.

[0099] In exemplary embodiment 26, which includes exemplary embodiment 25, the first pulse frequency is between 3.75 Hz and 4.25 Hz, the second pulse frequency is between 1.25 Hz and 1.75 Hz, and the third pulse frequency is between 0.25 Hz and 0.75 Hz.

[0100] In exemplary embodiment 27, which includes exemplary embodiment 25, the first pulse frequency is 3.9 Hz, the second pulse frequency is 1.5 Hz, and the third pulse frequency is 1 Hz.

[0101] In exemplary embodiment 28, including any one of exemplary embodiments 25 to 27, the first stimulation pattern, the second stimulation pattern, or the third stimulation pattern stimulates at predetermined time intervals.

[0102] In exemplary embodiment 29, which includes exemplary embodiment 28, the predetermined time interval is 25 to 35 seconds.

[0103] In exemplary embodiment 30, which includes exemplary embodiment 28 or 29, the predetermined time interval is 30 seconds.

[0104] In exemplary embodiment 31, which may include any one of exemplary embodiments 1-30, the headset is in operative communication with an external controller.

[0105] Exemplary embodiment 32 includes a method of treating a neurological disorder or disease or providing performance enhancement using the method of exemplary embodiment 1.

[0106] In exemplary embodiment 33, including exemplary embodiment 32, the neurological disease or condition comprises insomnia, PTSD, stroke, or other brain injury such as traumatic brain injury (TBI) or mild traumatic brain injury (mTBI).

[0107] In exemplary embodiment 34, including exemplary embodiment 32, the performance enhancement is providing sleep, improving mental performance, or improving physical performance.

[0108] Exemplary embodiment 35 includes a device for providing stimuli to a user, the device including a frame configured to be worn on the user's head, a left light source configured to generate a left visual stimulation pattern, a right light source configured to generate a right visual stimulation pattern, a left auditory source configured to generate a left auditory stimulation pattern, a right auditory source configured to generate a right auditory stimulation pattern, and a controller coupled to the left light source, the right light source, the left auditory source, and the right auditory source, wherein the application of the left visual stimulation pattern, the application of the right visual stimulation pattern, the application of the left auditory stimulation pattern, and the application of the right auditory stimulation pattern are controlled independently of each other by the controller but are coordinated with each other.

[0109] In exemplary embodiment 36, which includes exemplary embodiment 35, the left auditory source is further configured to generate a left tactile stimulation pattern, and the right auditory source is further configured to generate a right tactile stimulation pattern.

[0110] In exemplary embodiment 37, which includes exemplary embodiment 35 or 36, one or more of the left or right auditory sources includes a bone conduction vibrator.

[0111] In exemplary embodiment 38, which includes any one of exemplary embodiments 35-37, the controller is configured to communicate with and be operated by an external control unit.

[0112] In exemplary embodiment 39, which includes exemplary embodiment 38, the external control unit communicates wirelessly with the controller.

[0113] In exemplary embodiment 40, which includes exemplary embodiment 38 or 39, the external control unit includes one or more of a personal computer, a laptop computer, a tablet computer, a smartphone, or a wearable computer.

[0114] In exemplary embodiment 41, which includes any one of exemplary embodiments 38-40, the external control unit is running an application configured to interface with the controller and operate the controller.

[0115] In exemplary embodiment 42, which includes any one of exemplary embodiments 35-41, one or more of the left light source or the right light source includes a light emitting diode (LED).

[0116] In exemplary embodiment 43, which includes any one of exemplary embodiments 35-42, one or more of the left light source or the right light source is configured to generate light between 550 and 610 nm.

[0117] In exemplary embodiment 44, which includes any one of exemplary embodiments 35-42, one or more of the left light source or the right light source is configured to produce light at 580 nm.

[0118] Exemplary embodiment 45 includes a method of providing stimuli to a user, the method including the steps of simultaneously providing a left-side light stimulus to a user's left eye, a right-side light stimulus to a user's right eye, a left-side auditory stimulus to the user's left side, and a right-side auditory stimulus to the user's right side during a first time interval; alternating between providing the left-side light stimulus and the left-side auditory stimulus and providing the right-side light stimulus and the right-side auditory stimulus during a second time interval; alternating between providing the left-side light stimulus and the right-side light stimulus and providing the left-side auditory stimulus during a third time interval; and alternating between providing the left-side light stimulus and the right-side auditory stimulus and providing the right-side light stimulus and the left-side auditory stimulus during a fourth time interval.

[0119] In exemplary embodiment 46, which includes exemplary embodiment 45, the second time interval is after the first time interval, the third time interval is after the second time interval, and the fourth time interval is after the third time interval.

[0120] In exemplary embodiment 47, which includes exemplary embodiment 45 or 46, one or more of the left light stimulus or the right light stimulus includes pulsing light at a predetermined pulse frequency at one or more of a first time interval, a second time interval, a third time interval, or a fourth time interval.

[0121] In exemplary embodiment 48, which includes any one of exemplary embodiments 45-47, one or more of the left auditory stimulus or the right auditory stimulus includes generating an auditory sound at a predetermined generated frequency in one or more of a first time interval, a second time interval, a third time interval, or a fourth time interval.

[0122] In exemplary embodiment 49, which includes any one of exemplary embodiments 45-48, the left light stimulus, the right light stimulus, the left auditory stimulus, and the right auditory stimulus are generated using a wearable headset.

[0123] Exemplary embodiment 50, which includes any one of exemplary embodiments 45-49, further includes providing a left tactile stimulus simultaneously with the left auditory stimulus, and providing a right tactile stimulus simultaneously with the right auditory stimulus.

[0124] Exemplary embodiment 51 includes a method of treating a neurological disorder or disease or providing performance enhancement using the method of exemplary embodiment 45.

[0125] In exemplary embodiment 52, including exemplary embodiment 51, the neurological disease or condition includes insomnia, PTSD, stroke, or other brain injury such as traumatic brain injury (TBI) or mild traumatic brain injury (mTBI).

[0126] In exemplary embodiment 53, including exemplary embodiment 51, the performance enhancement is providing sleep, improving alpha wave activity, improving mental performance, or improving physical performance.

[0127] Exemplary embodiment 54 includes a method of providing stimulation to a user, the method including the steps of providing a headset to be worn by a user, applying a left auditory stimulation pattern to the left side of the user's head via the headset, and applying a right auditory stimulation pattern to the right side of the head via the headset, wherein the application of the left auditory stimulation pattern and the application of the right auditory stimulation pattern are coordinated with each other.

[0128] In exemplary embodiment 55, which includes exemplary embodiment 54, the left and right auditory stimulation patterns are configured to generate multiple concurrent left and right auditory signals.

[0129] In exemplary embodiment 56, which includes exemplary embodiment 54, the left and right auditory stimulation patterns are configured to generate a plurality of alternating left and right auditory signals.

[0130] In exemplary embodiment 57, which includes any one of exemplary embodiments 54-56, one or more of the left auditory stimulation pattern or the right auditory stimulation pattern has an auditory frequency between 240 Hz and 480 Hz.

[0131] In exemplary embodiment 58, which includes any one of exemplary embodiments 54-57, one or more of the left auditory stimulation pattern or the right auditory stimulation pattern has an auditory frequency of 256 Hz or 432 Hz.

[0132] In exemplary embodiment 59, which includes any one of exemplary embodiments 54-58, one or more of the left auditory stimulation pattern or the right auditory stimulation pattern includes a sequence of stimulation patterns, each having a pulse frequency and a pulse period, and the repetitive time signal includes a portion of the pulse period and includes an auditory frequency between 240 Hz and 480 Hz and a portion of the pulse period.

[0133] In exemplary embodiment 60, including exemplary embodiment 59, the portion of the pulse period is half a pulse period.

[0134] In exemplary embodiment 61, which includes exemplary embodiment 59 or 60, the sequence of stimulation patterns includes a first stimulation pattern having a first pulse frequency, a second stimulation pattern having a second pulse frequency that is less than the first pulse frequency, and a third stimulation pattern having a third pulse frequency that is less than the second pulse frequency.

[0135] In exemplary embodiment 62, which includes exemplary embodiment 61, the first pulse frequency is between 3.75 Hz and 4.25 Hz, the second pulse frequency is between 1.25 Hz and 1.75 Hz, and the third pulse frequency is between 0.25 Hz and 0.75 Hz.

[0136] In exemplary embodiment 63, which includes exemplary embodiment 62, the first pulse frequency is 3.9 Hz, the second pulse frequency is 1.5 Hz, and the third pulse frequency is 1 Hz.

[0137] In exemplary embodiment 64, including any one of exemplary embodiments 61-63, the first stimulation pattern, the second stimulation pattern, or the third stimulation pattern stimulates at predetermined time intervals.

[0138] In exemplary embodiment 65, which includes exemplary embodiment 64, the predetermined time interval is between 25 and 35 seconds.

[0139] In exemplary embodiments 66, including exemplary embodiment 64, the predetermined time interval is 30 seconds.

[0140] In exemplary embodiment 67, which may include any one of exemplary embodiments 54-66, the headset is in operative communication with an external controller.

[0141] Exemplary embodiment 68 includes a method of treating a neurological disorder or disease or providing performance enhancement using the method of exemplary embodiment 54.

[0142] In exemplary embodiment 69, including exemplary embodiment 68, the neurological disease or condition includes insomnia, PTSD, or brain injury such as traumatic brain injury (TBI) or mild traumatic brain injury (mTBI), or stroke.

[0143] In exemplary embodiment 70, including exemplary embodiment 68, the performance enhancement is providing sleep, improving mental performance, or improving physical performance.

[0144] Exemplary embodiment 71 includes a method of treating a user with post-traumatic stress disorder (PTSD), the method including: receiving a set of sensory stimulation instructions by a processor in a headset configured to be worn on the user's head; administering a therapeutically effective amount of sensory stimulation to the user in response to receiving the set of sensory stimulation instructions, the sensory stimulation alternating between a first sensory stimulation including simultaneously providing a left visual stimulation pattern to the user's left eye and a right auditory stimulation pattern to the right side of the head, and a second sensory stimulation including simultaneously providing a right visual stimulation pattern to the user's right eye and a left auditory stimulation pattern to the left side of the user's head, the first sensory stimulation and the second sensory stimulation including a first stimulation pattern having a first pulse frequency, a second stimulation pattern having a second pulse frequency, and a third stimulation pattern having a third pulse frequency; and collecting a set of user data related to the administration of the therapeutically effective amount of sensory stimulation to the user.

[0145] In exemplary embodiment 72, which includes exemplary embodiment 71, one of the first pulse frequency, the second pulse frequency, or the third pulse frequency is 3.75 Hz or more and 4.25 Hz or less, or the first pulse frequency is 7.5 Hz or more and 8.5 Hz or less, the second pulse frequency is 2.5 Hz or more and 3.5 Hz or less, and the third pulse frequency is 0.5 Hz or more and 1.5 Hz or less.

[0146] In exemplary embodiment 73, which includes exemplary embodiment 71, administering a therapeutically effective amount of the sensory stimulus to the user occurs over a predetermined treatment period.

[0147] In exemplary embodiment 74, which includes exemplary embodiment 73, the predetermined treatment period is approximately 5 hours.

[0148] In exemplary embodiment 75, including exemplary embodiment 73, the predetermined treatment period is approximately two hours.

[0149] In exemplary embodiment 76, which includes exemplary embodiment 71, the first sensory stimulation further includes providing a right tactile stimulation pattern on the right side of the head simultaneously with the left visual stimulation pattern and the right auditory stimulation pattern, and the second sensory stimulation further includes providing a left tactile stimulation pattern on the left side of the head simultaneously with the right visual stimulation pattern and the left auditory stimulation pattern.

[0150] In exemplary embodiment 77, which includes exemplary embodiment 71, the set of user data includes at least one vital health statistic selected from the group consisting of pulse rate, body temperature, respiratory rate, and blood pressure.

[0151] Exemplary embodiment 78 includes a headset that provides a therapeutically effective amount of sensory stimulation to a user, the headset including a frame configured to be worn on a user's head; a processor configured to generate a plurality of inputs including a left light source input, a right light source input, a left auditory source input, and a right auditory source input; a left light source configured to generate a left visual stimulation pattern using the left light source input; a right light source configured to generate a right visual stimulation pattern using the right light source input; a left auditory source configured to generate a left auditory stimulation pattern using the left auditory source input; and a right auditory source configured to generate a right auditory stimulation pattern using the right auditory source input; the processor is further configured to administer the therapeutically effective amount of sensory stimulation to the user through the headset, the plurality of inputs alternating between a first input including simultaneously generating the left light source input and the right auditory source input and a second input including simultaneously generating the right light source input and the left auditory source input; the first input and the second input including a first stimulation pattern having a first pulse frequency, a second stimulation pattern having a second pulse frequency less than the first pulse frequency, and a third stimulation pattern having a third pulse frequency less than the second pulse frequency.

[0152] In exemplary embodiment 79, including exemplary embodiment 78, one of the first pulse frequency, the second pulse frequency, or the third pulse frequency is greater than or equal to 3.75 Hz and less than or equal to 4.25 Hz, or alternatively, the first pulse frequency is greater than or equal to 7.5 Hz and less than or equal to 8.5 Hz, the second pulse frequency is greater than or equal to 2.5 Hz and less than or equal to 3.5 Hz, and the third pulse frequency is greater than or equal to 0.5 Hz and less than or equal to 1.5 Hz.

[0153] In exemplary embodiment 80, which includes exemplary embodiment 78, the processor is further programmed to provide the sensory stimulation for a predetermined treatment period.

[0154] In exemplary embodiments 81, including exemplary embodiment 80, the predetermined treatment period is approximately 5 hours.

[0155] In exemplary embodiments 82, including exemplary embodiment 80, the predetermined treatment period is approximately two hours.

[0156] In exemplary embodiment 83, which includes exemplary embodiment 78, the plurality of inputs further includes a left tactile source input and a right tactile source input, and further includes a left tactile source configured to generate a left tactile stimulation pattern using the left tactile source input and a right tactile source configured to generate a right tactile stimulation pattern using the right tactile source input, the first input further includes generating the right tactile source input simultaneously with the left visual source input and the right auditory source input, and the second input further includes generating the left tactile source input simultaneously with the right visual source input and the left auditory source input.

[0157] Exemplary embodiment 84, including exemplary embodiment 78, further includes a data sensor configured to collect a set of user data, the set of user data including at least one vital health statistic selected from the group consisting of pulse rate, body temperature, respiratory rate, and blood pressure.

[0158] Exemplary embodiment 85 includes a system for treating a user with PTSD, the system including: a headset configured to be worn on a user's head, the headset including a frame, a left light source, a left auditory source, a right light source, and a right auditory source; and a processor communicatively coupled to the headset and a controller and configured to receive sensory stimuli from the controller and transmit the sensory stimuli to the headset, the sensory stimuli transmitted in a therapeutically effective amount, the sensory stimuli alternating between a first sensory stimulus including simultaneously providing a left visual stimulation pattern from the left light source to the user's left eye and a right auditory stimulation pattern from the right auditory source to the right side of the user's head, and a second sensory stimulus including simultaneously providing a right visual stimulation pattern from the right light source to the user's right eye and a left auditory stimulation pattern from the left auditory source to the left side of the user's head, the first sensory stimulation and the second sensory stimulation including a first stimulation pattern having a first pulse frequency, a second stimulation pattern having a second pulse frequency that is less than the first pulse frequency, and a third stimulation pattern having a third pulse frequency that is less than the second pulse frequency.

[0159] In exemplary embodiment 86, including exemplary embodiment 85, one of the first pulse frequency, the second pulse frequency, or the third pulse frequency is greater than or equal to 3.75 Hz and less than or equal to 4.25 Hz, or alternatively, the first pulse frequency is greater than or equal to 7.5 Hz and less than or equal to 8.5 Hz, the second pulse frequency is greater than or equal to 2.5 Hz and less than or equal to 3.5 Hz, and the third pulse frequency is greater than or equal to 0.5 Hz and less than or equal to 1.5 Hz.

[0160] In exemplary embodiment 87, which includes exemplary embodiment 85, the processor is further programmed to provide the sensory stimulation for a predetermined treatment period.

[0161] In exemplary embodiments 88, including exemplary embodiment 87, the predetermined treatment period is approximately two hours.

[0162] In exemplary embodiment 89, including exemplary embodiment 85, the first sensory stimulation further includes providing a right tactile stimulation pattern on the right side of the user's head simultaneously with the left visual stimulation pattern and the right auditory stimulation pattern, and the second sensory stimulation further includes providing a left tactile stimulation pattern on the left side of the user's head simultaneously with the right visual stimulation pattern and the left auditory stimulation pattern.

[0163] In exemplary embodiment 90, which includes exemplary embodiment 85, the headset includes a data sensor configured to collect a set of user data, the set of user data including at least one vital health statistic selected from the group consisting of pulse rate, body temperature, respiratory rate, and blood pressure.

[0164] While preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will occur to those skilled in the art without departing from the invention. It is understood that various alternatives to the specific embodiments of the invention described herein can be used in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

1. 1. A method of treating a user with post-traumatic stress disorder (PTSD), comprising: receiving a set of sensory stimulation instructions by a processor within a headset configured to be worn on the user's head; administering a therapeutically effective amount of a sensory stimulus to the user in response to receiving the set of sensory stimulus instructions, the sensory stimulus comprising: a first sensory stimulus including simultaneously presenting a left visual stimulus pattern to the user's left eye and a right auditory stimulus pattern to the right side of the head; alternating between a second sensory stimulus including simultaneously presenting a right visual stimulus pattern to the user's right eye and a left auditory stimulus pattern to the left side of the user's head; the first sensory stimulus and the second sensory stimulus include a first stimulation pattern having a first pulse frequency, a second stimulation pattern having a second pulse frequency, and a third stimulation pattern having a third pulse frequency; collecting a set of user data related to administration of the therapeutically effective amount of the sensory stimulus to the user.

2. 2. The method of claim 1, wherein one of the first pulse frequency, the second pulse frequency, or the third pulse frequency is greater than or equal to 3.75 Hz and less than or equal to 4.25 Hz, or the first pulse frequency is greater than or equal to 7.5 Hz and less than or equal to 8.5 Hz, the second pulse frequency is greater than or equal to 2.5 Hz and less than or equal to 3.5 Hz, and the third pulse frequency is greater than or equal to 0.5 Hz and less than or equal to 1.5 Hz.

3. 10. The method of claim 1, wherein administering the therapeutically effective amount of the sensory stimulus to the user occurs over a predetermined treatment period.

4. 4. The method of claim 3, wherein the predetermined treatment period is about 5 hours.

5. 4. The method of claim 3, wherein the predetermined treatment period is about 2 hours.

6. 2. The method of claim 1, wherein the first sensory stimulation further comprises providing a right tactile stimulation pattern on the right side of the head simultaneously with the left visual stimulation pattern and the right auditory stimulation pattern, and the second sensory stimulation further comprises providing a left tactile stimulation pattern on the left side of the head simultaneously with the right visual stimulation pattern and the left auditory stimulation pattern.

7. The method of claim 1 , wherein the set of user data includes at least one vital health statistic selected from the group consisting of pulse rate, body temperature, respiratory rate, and blood pressure.

8. 1. A headset for providing a therapeutically effective amount of sensory stimulation to a user, comprising: a frame configured to be worn on the user's head; a processor configured to generate a plurality of inputs including a left light source input, a right light source input, a left auditory source input, and a right auditory source input; a left light source configured to generate a left visual stimulus pattern using the left light source input; a right light source configured to generate a right visual stimulus pattern using the right light source input; a left auditory source configured to generate a left auditory stimulus pattern using the left auditory source input; a right auditory source configured to generate a right auditory stimulus pattern using the right auditory source input; the processor is further configured to administer the therapeutically effective amount of the sensory stimulus to the user via the headset; The plurality of inputs include: a first input including simultaneously generating the left light source input and the right auditory source input; a second input including simultaneously generating the right light source input and the left auditory source input; the first input and the second input include a first stimulus pattern having a first pulse frequency, a second stimulus pattern having a second pulse frequency less than the first pulse frequency, and a third stimulus pattern having a third pulse frequency less than the second pulse frequency.

9. 9. The headset of claim 8, wherein one of the first pulse frequency, the second pulse frequency, or the third pulse frequency is between 3.75 Hz and 4.25 Hz, inclusive; or the first pulse frequency is between 7.5 Hz and 8.5 Hz, inclusive, the second pulse frequency is between 2.5 Hz and 3.5 Hz, inclusive, and the third pulse frequency is between 0.5 Hz and 1.5 Hz, inclusive.

10. The headset of claim 8 , wherein the processor is further programmed to provide the sensory stimulation for a predetermined therapeutic period.

11. The headset of claim 10, wherein the predetermined treatment period is approximately 5 hours.

12. The headset of claim 10, wherein the predetermined treatment period is approximately two hours.

13. the plurality of inputs further includes a left tactile source input and a right tactile source input; a left tactile source configured to generate a left tactile stimulus pattern using the left tactile source input; a right tactile source configured to generate a right tactile stimulus pattern using the right tactile source input; the first input further comprises generating the right tactile source input simultaneously with the left light source input and the right auditory source input; The headset of claim 8 , wherein the second input further comprises generating the left tactile source input simultaneously with the right light source input and the left auditory source input.

14. 10. The headset of claim 8, further comprising a data sensor configured to collect a set of user data, the set of user data including at least one vital health statistic selected from the group consisting of pulse rate, body temperature, respiratory rate, and blood pressure.

15. 1. A system for treating a user with post-traumatic stress disorder (PTSD), comprising: a headset configured to be worn on the user's head, the headset including a frame, a left light source, a left auditory source, a right light source, and a right auditory source; a processor communicatively coupled to the headset and the controller and configured to receive sensory stimuli from the controller and transmit the sensory stimuli to the headset; The sensory stimulus is delivered in a therapeutically effective amount, the sensory stimulus comprising: a first sensory stimulus including simultaneously providing a left visual stimulus pattern to the user's left eye from the left light source and a right auditory stimulus pattern to the right side of the user's head from the right auditory source; alternating between a second sensory stimulus including simultaneously providing a right visual stimulus pattern from the right light source to the user's right eye and a left auditory stimulus pattern from the right auditory source to the left side of the user's head; The system, wherein the first sensory stimulus and the second sensory stimulus include a first stimulation pattern having a first pulse frequency, a second stimulation pattern having a second pulse frequency less than the first pulse frequency, and a third stimulation pattern having a third pulse frequency less than the second pulse frequency.

16. 16. The system of claim 15, wherein one of the first pulse frequency, the second pulse frequency, or the third pulse frequency is between 3.75 Hz and 4.25 Hz, inclusive; or the first pulse frequency is between 7.5 Hz and 8.5 Hz, inclusive, the second pulse frequency is between 2.5 Hz and 3.5 Hz, inclusive, and the third pulse frequency is between 0.5 Hz and 1.5 Hz, inclusive.

17. 16. The system of claim 15, wherein the processor is programmed to provide the sensory stimulation for a predetermined treatment period.

18. 18. The system of claim 17, wherein the predetermined treatment period is approximately two hours.

19. 16. The system of claim 15, wherein the first sensory stimulation further comprises providing a right tactile stimulation pattern on the right side of the user's head simultaneously with the left visual stimulation pattern and the right auditory stimulation pattern, and the second sensory stimulation further comprises providing a left tactile stimulation pattern on the left side of the user's head simultaneously with the right visual stimulation pattern and the left auditory stimulation pattern.

20. 16. The system of claim 15, wherein the headset includes a data sensor configured to collect a set of user data, the set of user data including at least one vital health statistic selected from the group consisting of pulse rate, body temperature, respiratory rate, and blood pressure.

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