NZ743587B2 - Methods and systems for providing stimuli to the brain - Google Patents

Abstract

Visual and auditory stimuli are provided to a patient to treat various neurological disorders or conditions. The visual and auditory stimuli are provided by a wearable headset or sleep mask that may be comfortably worn by a user, such as in bed to induce sleep. The wearable headset or sleep mask is operated by a personal computing device of the user, such as smartphone, having downloaded and active thereon a control application or app for the therapy. The wearable headset or sleep mask also concurrently provides tactile stimuli, and the tactile stimulus is provided from bone conduction transducers that concurrently provides the auditory stimuli. operated by a personal computing device of the user, such as smartphone, having downloaded and active thereon a control application or app for the therapy. The wearable headset or sleep mask also concurrently provides tactile stimuli, and the tactile stimulus is provided from bone conduction transducers that concurrently provides the auditory stimuli.

Description

S AND SYSTEMS FOR ING STIMULI TO THE BRAIN CAL FIELD The present disclosure relates to medical devices and methods. In particular, the present disclosure relates to providing stimuli to a subject to treat various neurological disorders or conditions and/or to provide performance enhancement.

BACKGROUND ART Sensory stimulation has been applied to treat various disorders. For example, binaural beats have d to induce various mental states to encourage sleep, relaxation, meditation, creativity, and other desirable mental . Combinations of auditory and visual stimuli have been applied to age such mental states as well. The application of such therapy, however, has been less than ideal in many circumstances. Equipment to e the stimulus can be bulky, expensive, generally inaccessible, and below the critical efficacy threshold for widespread use, typically only helping subsets of the population. Users may find the use of such equipment difficult in many stances, such as when trying to sleep in a bedroom or an ne cabin.

To treat various neurological disorders and conditions, pharmaceuticals and/or supplements are often used instead of sensory stimulation. The use of pharmaceuticals, r, can be less than ideal in many circumstances. Often, pharmaceuticals are expensive, rely on patient-compliance, and may require a prescription from a medical professional. Pharmaceuticals may be effective in only a small, less than ideal portion of the general population. To treat insomnia, for example, pharmaceuticals and supplements such as melatonin and Zolpidem (e.g., AmbienTM) have questionable efficacy. ceuticals often lead to undesirable side effects.

For example, some pharmaceutical for treating insomnia can lead to deprivation in certain ranges of deep sleep and increases in mortality rates.

For at least these reasons, improved methods and s to treat neurological disorders and other conditions that me at least some of the entioned challenges are desired.

DISCLOSURE OF INVENTION The present disclosure relates to medical devices and methods which may be used, for example, to provide stimulus to a subject to treat various neurological disorders or conditions, where the stimulus provided may include one or more of an auditory, a visual, or a tactile us. Examples of ogical disorders which may be treated with devices and methods may include, but are not limited to, insomnia, post-traumatic stress disorder (PTSD), brain injuries including, but not d to traumatic brain injury (TBI), mild traumatic brain injury (mTBI), or injury from oxygen deprivation of the brain from strokes, depression, anxiety, mood disorders, personality disorders, eating disorders, psychotic disorders, and balance disorders, to name a few. atively or in combination, the stimulus provided by the medical devices and methods described herein may provide cognitive benefits and/or enhancement, ing, but not limited to, improving neuroplasticity, motor skills, nation, reaction times, alertness, energy, working memory, mood, and feelings of wellbeing.

In certain embodiments, stimuli may be ed to the wearer of a t or sleep mask that may be comfortably worn by a user, such as in bed to induce sleep. The wearable headset or sleep mask may be operated by a personal computing device of the user, such as smartphone, having downloaded and active thereon a control application or “app” for the therapy. The wearable headset or sleep mask may also concurrently provide e i, and the tactile stimuli may be provided from bone conduction transducer that may concurrently provide the auditory stimuli. Various patterns of the stimuli to induce ent user responses are also disclosed.

In certain embodiments, a device is provided that produces an output that may be perceived by a user of the device as a visual, auditory or tactile stimuli at one or more frequencies, or in one or more frequency ranges. In certain ments, the stimuli may be turned on and off at frequencies that are believed to induce one or more frequencies of electrical activity in the brain, which are generally accepted as being delta waves (1.0 to 3.0 Hz), theta waves (30 to 7.0 Hz), alpha waves (7 .0 to 12 Hz), beta waves (12 to 38 Hz), and gamma waves (38 to 42 Hz).

Thus, for example, one embodiment device es an output that may be perceived by a user of the device as a stimuli at sequential frequencies, such as sequences of alpha waves, theta waves, and delta waves. In certain embodiments, the stimuli is a coordinated auditory and visual stimulation, providing right and left eyes and ears to pulsed light and pulsed auditory in each of the ranges listed above. As one example, the coordinated stimulation may be: 1) both eyes and both ears being stimulated at the same time; 2) the left eye and ear being ated at the same time, followed by the right eye and ear being stimulated at the same time; 3) both eyes being stimulated at the same time, followed by both ears being stimulated at the same time; or 4) the right eye and left ear being stimulated at the same time, followed by the left eye and right eye being stimulated at the same time. In each case, the ation may include, for example, sequentially stimulating in the alpha wave range, followed by the theta wave range, ed by the delta wave range. The stimulation can last for a period of one minute up to an hour.

It is one aspect to e a method to provide ation to a user. The method includes: providing a headset to be worn by the user; ng, with the headset, a left visual stimulus pattern to the left eye of the user; applying, with the headset, a right visual stimulus pattern to the right eye of the user; applying, with the headset, a left auditory stimulus pattern to the left side of a head of the user; and applying, with the headset, a right auditory stimulus pattern to the right side of the head. The applications of the left visual stimulus pattern, the right visual stimulus pattern, the left auditory stimulus pattern, and the right auditory stimulus pattern are coordinated with one another.

It is another aspect to provide a method of treating a neurological disease or condition or providing performance enhancement using the method of ing stimulation to a user. The method includes: providing a headset to be worn by the user; applying, with the headset, a left visual stimulus pattern to the left eye of the user; applying, with the headset, a right visual us pattern to the right eye of the user; applying, with the headset, a left ry stimulus pattern to the left side of a head of the user; and applying, with the headset, a right auditory stimulus pattern to the right side of the head. The applications of the left visual stimulus pattern, the right visual stimulus pattern, the left auditory stimulus pattern, and the right auditory stimulus pattern are coordinated with one another.

It is one aspect to provide an apparatus to provide ation to a user. The apparatus includes: a frame configured to be worn on a head of a user; a left light source configured to generate a left visual stimulus pattern; a right light source configured to generate a right visual stimulus pattern; a left auditory source configured to generate a left auditory stimulus pattern; a right auditory source configured to generate a right auditory stimulus n; and a ller coupled to the left light source, the right light source, the left auditory , and the right auditory , The applications of the left visual stimulus pattern, the right visual stimulus pattern, the left auditory stimulus pattern, and the right auditory stimulus pattern are independently controlled from one another but coordinated with one another by the controller.

It is yet another aspect to provide a method to provide stimulation to a user, the method includes: concurrently providing a left-side light us to a left eye of the user, a right- side light stimulus to a right eye of the user, a left-side ry stimulus to a left side of the user, and a right-side ry stimulus to a right side of the user for a first time interval; alternating providing the left-side light stimulus and left-side ry stimulus with providing the right-side light stimulus and right-side auditory stimulus for a second time interval; alternating providing the left-side and right-side light stimuli with providing the ide and right-side auditory stimuli for a third time interval; and alternating providing the left-side light stimulus and right- side auditory stimulus with providing the right-side light stimulus and left-side auditory stimulus for a fourth time interval.

It is one aspect to provide a method of treating a neurological disease or condition or providing mance enhancement using the method of concurrently providing a left-side light stimulus to a left eye of the user, a right-side light stimulus to a right eye of the user, a left-side auditory stimulus to a left side of the user, and a right-side auditory stimulus to a right side of the user for a first time interval; alternating providing the left-side light stimulus and left—side auditory stimulus with providing the right-side light us and right-side auditory stimulus for a second time interval; alternating providing the left—side and right-side light stimuli with providing the left-side and right-side auditory stimuli for a third time al; and alternating providing the left-side light us and right-side auditory stimulus with ing the right- side light stimulus and left-side auditory stimulus for a fourth time al.

It is another aspect to e a method of providing stimulation to a user, The method includes: providing a headset to be worn by the user; applying, with the headset, a left auditory stimulus pattern to the left side of a head of the user; and applying, with the headset, a right auditory stimulus pattern to the right side of the head, The applications of the left auditory stimulus pattern and the right ry us pattern are coordinated with one r.

These features together with the various ancillary provisions and es which will become apparent to those skilled in the art from the following detailed description, are attained by the methods and system for providing stimulation to a user of the present ion, embodiments thereof being shown with reference to the accompanying gs, by way of example only, wherein: BRIEF DESCRIPTION OF DRAWINGS FIGS. 1A and 1B show schematic diagrams of therapeutic systems to provide therapeutic auditory, visual, and/or tactile stimulus, according to many embodiments of the present disclosure; FIGS. 2A and 2B show schematic diagrams of the controller for the therapeutic systems of FIGS. 1A and 1B; shows an exemplary therapeutic wearable headset or sleep mask, according to many embodiments; shows a user wearing the therapeutic wearable headset and sleep mask of ; and shows a flow chart of a therapeutic method of providing therapeutic auditory, visual, and/or tactile us, according to several embodiments.

MODES FOR NG OUT THE INVENTION FIGURE 1A is a schematic diagram of a first ment therapeutic system 100.

Therapeutic system 100 provides one or more outputs that a person wearing the therapeutic system may ence as auditory, , and/or e stimulus. Thus, in one embodiment, therapeutic system may comprise 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 action of the light and vibration sources. Thus, for example, therapeutic system 100 may be positioned on the head of a user with left light source 110L positioned over the left eye to provide a left visual stimuli, right light source 110R positioned over the right eye to provide a right visual stimuli, left vibration source 120L positioned to provide left ear auditory stimuli, and right Vibration source 120R positioned to provide right ear auditory stimuli.

In one embodiment, left and right light sources 110L, 110R may each comprise light- ng diodes, an incandescent light source having a wavelength filter, a fluorescent light source, a backlit LCD panel, or other light source configured to provide to the user light at a desired, ermined wavelength or wavelength range.

In another embodiment, left and right ion sources 120L, 120R may each comprise earbuds, miniature speakers, or other vibration sources that can provide auditory stimuli to a user. In certain other embodiments, left and right vibration sources 120L, 120R may comprise bone conduction transducers in the e frequency range to provide vibrations to the user’s skull bone that is sensed as auditory by the user’s ear. Optionally, one or more of left and right vibration sources 120L, 120R may also produce vibrations that are sensed as tactile stimuli.

Thus, for example, controller 130 may provide first signals to bone conduction transducers that vibrate or oscillate at a first frequency that can be interpreted by the user as auditory stimuli and may provide second signals at a second, lower frequency that can be reted as a tactile sensation by the user. In other words, bone conduction transducers may be adapted to provide both auditory and e stimulus to the user.

In n embodiments, left and right vibration sources 120L, 120R provide output at specific one or more frequencies or a range of frequencies, and are turned on and off at a stimulation frequency. Thus, for example, a vibration source may be programmed to provide an output at an audio frequency of 256 Hz for some period of time, followed by no output for the following period of time. Thus, the vibration source is the product of an audio frequency and a square wave.

FIGURE 1B is a schematic m of a second ment therapeutic system 100’.

Second embodiment therapeutic system 100’ is generally similar to first embodiment therapeutic system 100’, except as explicitly noted. Specifically, second ment therapeutic system 100’ includes a left tactile us source 121L and a right tactile stimulus source 121R, each of which may be individually controlled and coordinated with the controller 130 to provide tactile stimuli to a user of therapeutic system 100’.

FIGURES 2A and 2B show schematic diagrams of the controller 130 of therapeutic system 100 or 100’. As shown in , eutic system 100 or 100’ may optionally include an external l unit 13021 that may wirelessly communicate with a wireless receiver/transmitter 130C of the ller 130 through a wireless connection 131a. The wireless connection 131a may comprise a oth connection, a Bluetooth LE connection, a WiFi connection, a ZigBee connection, an infrared (IR) connection, a radiofrequency (RF) tion, or an inaudible auditory signal connection, to name a few examples. The external control unit 130a may comprise a custom-built, electronic controller. In many embodiments, the external control unit 130a may comprise a al computing device of the user that may have downloaded onto and operating, a custom computer application or “app” to operate the system 100 or 100’ to provide a therapeutic regimen. For example, the personal computing device may comprise a personal computer, a personal laptop computer, a tablet computer (such as an Apple iPad, a Samsung Galaxy Tab, a Microsoft Surface, or an Amazon Fire, to name a few examples), a smartphone (such as an Apple iPhone, a Samsung Galaxy phone, or a Google Nexus phone, to name a few examples), and the custom computer application or “app” may be an application or “app” downloadable from an application distribution platform such as Apple iTunes, Apple Store, Google Play, Google Chrome Web Store, Amazon App Store, or Microsoft Windows Store, to name a few examples. The application may e one or more eutic regimens that the user may select for implementation by the therapeutic system 100 or 100’. In some embodiments, the application may allow the user to provide feedback information about the efficacy of the therapeutic regimen(s), the feedback may be uploaded and collected by a central server(s) in communication with the ation, and the eutic regimen(s) may be improved or optimized based on the feedback from the one or more users. atively or in combination, as shown in , the system 100 or 100’ may further comprise an external control unit 130a, such as a custom-built controller, that may communicate with the controller 130 through a wired connection 13121, for example, a USB, FireWire, or Lightning connection, to name a few examples.

FIGURE 3A shows one embodiment ofthe therapeutic system 100 as including therapeutic wearable headset or sleep mask 140 which integrates the light, vibration, and, optionally, tactile sources into a single form factor for presentation to a user. Thus, for example, when a user places le headset or sleep mask 140 on their head, left light source 110L is positioned over the left eye to provide a left visual stimuli, right light source 110R is positioned over the right eye to provide a right visual stimuli, left vibration source 120L is positioned to provide left ear auditory stimuli, and right vibration source 120R is positioned to provide right ear auditory stimuli.

As discussed above and herein, the left vibration source 120L and the right ion source 120R may each comprise bone conduction transducer that may provide both auditory and tactile stimulus. Alternatively, wearable headset or sleep mask 140 is therapeutic system 100’ which includes left tactile stimulus source 121L and right tactile stimulus source 121R, each of which may be dually controlled and coordinated with the controller 130, as described above regarding .

As discussed above and herein, the therapeutic le headset or sleep mask 140 may be ed with an external controller 130a (e.g., a hone) in communication with the controller 130 through a ss connection 131a, for example. The user US may have an option to turn tactile stimulation on or off, for example. shows a user US wearing the eutic le headset or sleep mask 140.

FIGURE 4 shows a flow chart of an exemplary therapeutic method 400 for providing therapeutic auditory, visual, and/or tactile stimulus. In a step 410, a subject having a neurological er or condition may be identified. Examples of neurological disorders may include, but are not limited to, insomnia, post-traumatic stress disorder (PTSD), brain es such as traumatic brain injury (TBI), mild traumatic brain injury (mTBI), or es to the brain due to oxygen deprivation, such as strokes, depression, anxiety, mood disorders, personality disorders, eating disorders, and psychotic disorders. Alternatively, a subject may be selected to undergo a therapeutic method 400 for the purpose of performance enhancement of mental and/or physical tasks for to aid the subject in napping or sleeping. In a step 420, the subject may be provided the therapeutic system or headwear, such as the system 100 or 100’ described above. In a step 430, the subject may wear the eutic system or headwear, such as wearable headset or sleep mask 140. In a step 440, headset 140 executes programming 450 provided in controller 130 to provide stimuli to the subject. The programming es two or more of auditory, video, and/or tactile stimulus are concurrently provided by headset 140 to the t, and thus, for e, may provide power to activate left light source 110L, right light source 110R, left vibration source 120L and or right vibration source 120R.

As discussed above and herein, the left vibration source 120L and the right vibration source 120R may each comprise bone conduction transducer that may provide both auditory and tactile stimulus. atively, wearable headset or sleep mask 140 is therapeutic system 100’ which includes left tactile stimulus source 121L and right tactile stimulus source 121R, each of which may be individually controlled and coordinated with the controller 130, as described above regarding .

In n embodiments, providing two or more of auditory, video, and/or tactile stimulus concurrently may provide improved therapeutic benefits as compared to providing only one of auditory, video, or tactile us at one time. The two or more auditory, video, and/or tactile stimulus may thus e to provide the improved eutic benefits, for example (i.e., the two or more auditory, video, and/or tactile stimulus may ize in a way to provide improved results over providing two of the stimuli individually.) Exemplary instructions for providing stimuli may be ed, for example, by programming 450, such as a subroutine 450a, which includes the simultaneous activation of all active auditory, video, and/or tactile stimulus sources. Optionally, the activation of all s may include the activation of tactile stimulation to run throughout all subsequent auditory and/or visual stimulation. Another exemplary subroutine 450b may comprise alternating the left ry, video, and/or tactile stimulus sources with the right auditory, video, and/or tactile us sources (i.e., the left stimuli and right stimuli take turns being active.) Another exemplary subroutine 450C may comprise alternating the visual sources with the auditory and/or tactile sources (i.e., the visual stimuli and the auditory/tactile stimuli take turns being active.) r exemplary subroutine 450d may comprise alternating the left auditory and/or tactile source and the right visual source with the right auditory and/or tactile source and the left visual source (i.e., opposite auditory/tactile stimuli take turns being active.) Such programming is r described below.

In step 440, programming 450, ing by not limited to subroutines 450a, 450b, 450C, and 450d, may each be applied one or more times, individually or in combination with one another. The programming may, in addition, provide sequences of output in subroutines 450a, 450b, 450e, and 450d at different frequencies and/or timings. Thus for example the subroutines may provide output at specific frequencies that change as the tine is repeated. Thus for example, tine 450a may provide auditory output to vibration source 120R or 120L at a frequency of 256 Hz that is turned on and off, that is it is pulsed, at a pulse ncy of 1 Hz for 2 minutes. This square pulse auditory signal thus generates signals at a frequency of 1 Hz in addition to higher harmonics. At a uent time the output at 256 Hz is pulsed at twice the previous pulse frequency for 2 minutes. In this manner, the auditory frequency of 256 Hz may be modulated over a wide range, including frequencies corresponding to brain wave ncies.

In addition, by ng the output between left and right channels, the brain may be stimulated in a way that it is forced to communicate n the left and right sides of the brain.

This forced communication, for example, can allow PTSD memories to be wired to both sides of the brain, thereby stopping undesirable flashbacks.

Although the above steps show method 400 of treating a t in accordance with embodiments, a person of ordinary skill in the art will recognize many variations based on the teaching described herein. The steps may be completed in a different order. Steps may be added or deleted. Some of the steps may comprise sub-steps. Many of the steps may be repeated as often as beneficial to the treatment.

One or more of the steps of the method 400 may be performed with the circuitry as described herein, for example, circuitry of the controller 130 or the external control unit 130a such as one or more of a processor or logic circuitry such as a central processing unit (CPU) or a programmable array logic for field mmable gate array. The circuitry may be programmed to provide one or more of the steps of the method 400, and the program may comprise program instructions stored on a computer readable memory or programmed steps of the logic try such as the programmable array logic or the field mmable gate array, for example.

EXAMPLE I The following describes an example of a stimulation pattern that has been found by empirical studies to be effective for inducing sleep, including napping, increasing neuroplasticity, treating brain injuries from strokes, TBI, or mTBI, improving balance, including improving fine motor control and reaction times, and treating PTSD, to name a few indications.

Light and auditory stimulus at a first frequency may be provided for a first time segment, then at a second lower frequency for a second time t, and then at a third lower frequency for a third time segment. Each time segment may include one or more gments of light and auditory stimulus, each sub-segment comprising one of the subroutines described above, for example. The light and auditory stimulus may end after a pre—determined time period, such as 20 minutes. The light and auditory stimulus may be ramped back up (i.e., ng from the third frequency, then transitioning to the second ncy, and finally transitioning to the third frequency), such as to wake the user. Alternatively or in combination, the light and auditory stimulus may be maintained at the second frequency such as to maintain a sleep state of the user.

As described above, tactile us may be provided concurrently with the auditory stimulus.

The light may be provided at a wavelength of 580 nm and the auditory having a frequency of 256 Hz may be provided, or any of a number of auditory ncies or combinations thereof that the subject can select as they wish.

Table 1 below describes an exemplary treatment regimen for this example. The stimulation provided in Table 1 first cycles through a block of four Segment A outputs, then cycles through a block of four Segment B s, then cycles through seven blocks of four Segment C outputs, and lastly repeats the block of four Segment A outputs. For Segment A outputs (A1, A2, A3, and A4), the auditory and light s cycle 115 or 116 times between being on for 0.1277 seconds and then being off for 0.1277 seconds (that is, at a pulse frequency of 3.9 Hz), followed by no output for 0.5 seconds. For t B s (B1, B2, B3 and B4), the auditory and light outputs cycle 44 or 45 times between being on for 0.3333 seconds and then being off for 0.3333 seconds (that is, at a pulse ncy of 1.5 Hz) followed by no output for 0.5 seconds. For Segment C outputs (C1, C2, C3 and C4), the auditory and light outputs cycle 14 or 15 times between being on for 1 second and then being off for 1 second (that is, a pulse frequency of 0.5 Hz), followed by no output for 1 second. Segments A1, B1, and C1 pulse the right and left sides of both the light and auditory together, with all outputs are synchronized to be on or off at the same time, as provided by subroutine 450a. Segments A2, B2, and C2 synchronize the left side light and auditory output, and the right side light and ry output to be opposite to one another, as provided by subroutine 450b. Segments A3, B3, and C3 synchronize both lights together to be opposite to both ry s, as provided by subroutine 450C. Segments A4, B4, and C4 synchronize the right auditory and light to be opposite to the left auditory and light outputs, as provided by subroutine 450d.

TABLE 1 Auditory ry . . . ts A1-A4 for 120s _—_— Segment Al (Light and Auditory On 0.1277s On 0.1277s On 0.1277s On 0.1277s both sides pulse together) Repeat 116 times, followed by Off 0. 1277s Off 0.1277s Off 0. 1277s Off 0.1277s Segment A2 (light and auditory on left side, alternating light and On 0.1277s Off 0.1277s On 0.1277s Off 0.1277s auditory on Right).

Repeat “6 bmbs’ foubwed by Off 0.1277s On 0.1277s Off 0.1277s On 0.1277s Segment A3 ( both lights together, ating with both On 0.1277s On s Off 0.1277s Off 0.1277s auditories together) Repeat “5 bmbs> fbllb‘yed by Off 0.1277s Off s On 0.1277s On 0.1277s Segment A4 (auditory left and light right together, alternating On 0.1277s Off 0.1277s Off 0. 1277s On 0.1277s auditory right and light left together) Repeat 115 times, followed by Off 0. 12775 On 0.1277s On 0.1277s Off 0.1277s Sements B1-B4 for 120s _—_— On 03333s On 0. 3333s On 0. 3333s On 0. 3333s both sides pulse together) Repeat 45 times, followed by 05 Off 0.33335 Off 0.3333s Off 0.3333s Off 0.33335 Segment B2 (light and auditory on left side alternating light and On 0.33335 Off 0.33335 On 0.33335 Off 5 auditory on Right) Repeat 44 bmbs’ fbllb‘yed by Off 033335 On 0,3333s Off 0,3333s On 0.33335 Segment B3 ( both lights together, alternating with both On 0.3333s On 0.3333s Off 0.3333s Off s auditories together) iii)“ bmbs’ fbub‘yed by 0'5 Off 0.3333s Off 0.3333s On 0.3333s On 0.3333s Segment B4 (auditory left and light right together, ating On s Off 0.3333s Off 0.3333s On s auditory right and light left together) Repeat 44 times, followed by 0.5 Off 0.3333s On 0.3333s On 0.3333s Off 0.3333s Repeat the following Segments C1-C4 7 times for a total of 14 minutes Segmentm (LightandAudnory both sides pulse together) Repeat 15 times, fOHOWBd by 1 Off 1 sec Off 1 sec Off 1 sec Off 1 sec on left side, alternating light and Off 1 sec Off 1 sec auditory on Right) Repeat 15 times, followed by 1 Off] sec Off1 sec sec gap t C3 ( both lights together, alternating with both On 1 sec On 1 sec Off 1 sec Off 1 sec auditories together) Segment C4 ory left and light right together, alternating On 1 sec Off 1 sec Off 1 sec On 1 sec ry right and light left together) Offl sec Repeat 14 times, followed by 1 Se_ments A1-A4 for 120s ___— Segment Al (Light and Auditory On 01277 On 01277 On 01277 On 0.1277 both sides pulse together) 0.5 sec gap on left side, alternating light and On 0,1277 Off 0.1277 On 0.1277 Off 0.1277 auditory on Right) 05 sec :ao together, alternating With both On 0.1277 On 0.1277 Off 0. 1277 Off 0.1277 auditories together) light right together, alternating On 0.1277 Off 0.1277 Off 0. 1277 On 0.1277 ry right and light left Repeat 115 times, followed by Off 0. 1277 On 0.1277 On 0.1277 Off 0.1277 0.5 sec gap EXAMPLE 2 The following describes an example of a stimulation pattern that has been found by empirical studies to be effective for inducing sleep. The stimulation pattern of Example 2 includes the part of the treatment regimen shown in Table 1. Specifically, the stimulation first cycles through a block of four Segment A outputs, then cycles through a block of four Segment B outputs, and then cycles through seven blocks of four Segment C outputs. The repetition of the last block of four Segment A s is not provided in Example 2.

EXAMPLE 3 The following described example of a stimulation pattem that has been found by empirical studies to be effective for increasing alpha wave brain activity, inducing neuroplasticity, treating stroke or other brain injuries such as TBI, mTBI, including ing balance, improving fine motor control and reaction times, and treating PTSD, to name a few indications.

In this example, the four subroutines described above and herein are applied and repeated for multiple time segments, each at a predetermined stimulation (repetition) ncy.

The four subroutines may be repeated, such as with each segment of the four subroutines lasting 120 seconds, for example. As described above, tactile stimulus may be provided concurrently with the auditory stimulus. The light may be provided at a wavelength of 580 nm and the auditory having a frequency of 432 Hz may be provided.

Table 2 below bes an exemplary treatment regimen for this example. The stimulation provided in Table 2 cycles through a block of four Segment A outputs 10 times. For Segment A1, A2, A3, and A4, the ry and light s cycle 115 or 116 times between being on for 0.1277 seconds and then being off for 0.1277 seconds, followed by no output for 0.5 seconds. Segments A1 pulses the right and left sides of both the light and auditory together, with all outputs are synchronized to be on or off at the same time, as provided by subroutine 450a.

Segment A2 onizes the left side light and auditory output, and the right side light and auditory output to be te to one another, as provided by subroutine 450b. Segment A3 synchronizes both lights together to be opposite to both auditory s, as provided by subroutine 450C. Segment A4 onizes the right auditory and light to be opposite to the left auditory and light outputs, as provided by subroutine 450d.

TABLE 2 Repeat the following Segments A1-A4 10 times for a total time of 20 minutes Segment A1 (Light and Auditory On 0.1277s On 0.1277s On 0.1277s On s both sides pulse together) Repeat 116 times, ed by 05 Off 0.1277s Off0.1277s Off 0.12775 Off 0.1277s sec gap Segment A2 (light and auditory on left side, alternating light and On s Off 0. 12775 On 0.12775 Off 0. 1277s auditory on Right) Repeat 116umes= fouowed by 0'5 Off 012775 On 0.12775 Off 0. 12775 On 0.12775 together, alternating With both On 0.12775 On 0.12775 Off 0. 12775 Off 0.12775 auditories together) light right er, alternating On 5 Off0. 12775 Off 0. 12775 On 0.12775 auditory right and light left together) sec gap EXAMPLE 4 The following described yet another example of a ation pattern that has been found by empirical studies to be effective for increasing energy levels in the t. Light and auditory stimulus at a first frequency may be provided for a first time segment, then at a second higher frequency for a second time segment, then back at the first frequency for a subsequent time segment, and so forth. Each time segment may include one or more sub—segments of light and auditory stimulus, each sub-segment comprising one of the tines bed above, for example. The light and auditory stimulus may end after a pre-determined time , such as 20 minutes. As described above, tactile stimulus may be provided concurrently with the auditory us. The light may be provided at a wavelength of 580 nm and the auditory having a frequency of 432 Hz may be provided.

Table 3 below describes an exemplary treatment regimen for this example. The stimulation provided in Table 3 cycles ten times first through a block of four Segment A outputs, then through a block of four Segment D outputs. For Segment A outputs (A1, A2, A3, and A4), the auditory and light outputs cycle 115 or 116 times n being on for 0.1277 seconds and then being off for 0.1277 seconds, followed by no output for 0.5 seconds. For Segment D outputs (D1, D2, D3 and D4), the auditory and light outputs cycle 44 or 45 times between being on for 0.0667 seconds and then being off for 0. 0667 seconds, followed by no output for 0.5 seconds.

Segments A1 and D1 pulse the right and left sides of both the light and auditory together, with all outputs are synchronized to be on or off at the same time, as provided by subroutine 450a.

Segments A2 and D2 synchronize the left side light and auditory output, and the right side light and auditory output to be opposite to one another, as ed by subroutine 450b. Segments A3 and D3 synchronize both lights together to be te to both auditory outputs, as provided by subroutine 450e, Segments A4 and D4 synchronize the right auditory and light to be opposite to the left ry and light outputs, as provided by subroutine 450d.

TABLE 3 —fggltory Auditory Right Light Left Light Right Repeat 10 times: Segments A1-A4 followed by Segments Segment A1 (Light and Auditory both sides pulse 0.5 sec gap auditory on left side, On 0.12775 Off 5 On 0.12775 Off 0.12775 alternating light and auditory Repeat 116 times, followed by Off 5 On 0.12775 Off 0.1277s On 0.12775 together, alternating with both On 0.1277s On 0.1277s Off 0.1277s OffO. 1277s auditories together) light right er, alternating On 0.1277s Off 0.1277s Off 0.12775 On 0.1277s auditory right and light left Repeat 115 times, followed by Off 0.12775 On 0.12775 On 0.12775 OffO. 12775 0.5 sec gap Segment D1 (Light and On 0.0667s On 0.0667s On 006675 On 0.0667s Auditory both sides pulse together) Off 0.0667s Off 0.0667s Off 0,0667s Off 0.0667s Repeat 221 times, ed by Segment D2 (light and auditory on left side, On 0.0667s Off 0.0667s On 0.06675 Off 0.0667s alternating light and auditory on Right) Repeat 221 times, followed by Off 0.06675 On 0.0667s Off s On 5 Segment D3 ( both lights together, alternating with both On 0.06675 On 0.06675 Off 0.0667s Off 0.06675 auditories together) Repeat 221 “mes’ fouowed by Off 0.06675 Off 0.0667s On 0.0667s On 0.06675 WO 91758 Segment D4 (auditory left and light right together, alternating On 0.0667s Off 0.0667s Off 006673 On 0.0667s auditory right and light left together) Repeat 221 times, followed by Off 006675 On 0.0667s On 0.0667s Off 0.0667s EXAMPLE 5 The following Table 4 lists experimental results for the use of the inventive methods.

The table lists what was being tested or treated, details of the conditions, the number of subjects, and the results of the tests. In each case, the stimulation in Example 1 for treating eep related problems and for inducing a short sleep, and the stimulation in Example 2 was used for all other treatments.

Several of the treatments provided improvements in al and/or mental performance, such as improving fine motor l and reaction times. This may be due to the device ing improved neuroplasticity in the days after treatment. Other treatments provided improvements in ming tasks and recovery from brain injury, such as injuries resulting from oxygen deprivation (strokes) and for those suffering from traumatic brain injury (TBI) or mild traumatic brain , and my provide improving balance, improving fine motor control. Other treatments provided relief to sufferers of PTSD by reducing the subj ect’s response to triggering stimuli.

TABLE 4 Reduction of chronic nerve damage pain and improvement Pain of sleep on self. Use of device Management for 3 months with 20 min/day of ISigniflcant improvements in marksmanship1n all participants and ease of concentration during speed driving, faster times on endurance rials for 19/20 subjects W0 2017l091758 Improved performance of fine motor skills on surgical procedures VR simulation for all subjects. % and 30% respectively increased speed in stripping and reassembling s. (average each of 5 tests, pre and post raining) 6% average improvement in marksmanship scores - highly significant for such level of skill for all sub'ects % e improvement in .

Total absence of any PTSD 1 L&S stimulation and biofeedback.

Group 2 - just L&S stimulation Brain State Group 3 just biofeedback, Group 4 control. Double blinded - those administering had no idea of what was oredicted to ha oen Dramatic ements in half of subjects. Small improvements in remaining half of subjects Successful in 31/33 subjects Driver performance using VR Immediate increase in reaction simulators for on speeds and speeds and improved uerformance under stress performance for all subjects -25% increase in speeds to complete performance. Trained for 4 hours, Batte of 21 tests All subjects fell asleep using the device during training, including one subject hat was ill with a virus and couldn't Subject won his first Grand Prix of the Subject went from 5th ranked to l ihest ranked Observable balance improvement in Use on 6 year post stroke subjects. 7/10 subjects. 3 SUbl ectshad had four hours training. dramatic improvements in their Effect on seizures of ensitive reduction in both severity and epileptics. 4 hours ng, , frequency of es, for at least a oeriod of at least one month, Concuss10n All subjects appeared to have recovery Effect on concussions 18 Recove | an oen at ve fast 5 eed.

Performance Effect on mus1cal ability of a Jazz 1 Greatly improved performance speed ement mus1c1an. 19 individuals saw a cessation of major ms - flashbacks, | ightmares, cold sweats and PTSD. Treatment protocol lasting 3 22 l ypervigilance. the remaining 3 sessions of 2 hours each appeared to be calmer after treatment, but did not stop the major neurological s mtoms _—-Goestos1ee4timesm45 mins Subject had constant pain on touching arms with no relief in 3 years Subject saw immediate pain relief on first use Pain of the device. ued use over the Chronic Regional Pam me. . .

Management following weeks results in periods of ime without pain grow up to four I ours following each use. Averaging at After six months of use, the subject continues getting 30% more sleep, and a significant reduction in pain. Device continues to be used 3-4 times a week for 20 min.

While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only, us variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various atives to the embodiments of the invention bed herein may be employed 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 It is to be understood that the invention includes all of the different combinations embodied herein. Throughout this specification, the term “comprising” shall be synonymous with “including,77 cccontaining,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. “Comprising” is a term of art which means that the named ts are essential, but other elements may be added and still form a construct within the scope of the ent. “Comprising” leaves open for the inclusion of unspecified ingredients even in major amounts.

Claims (31)

WHAT IS CLAIMED IS:

1. A non-therapeutic method of providing sensory stimulation to a user, the method comprising: alternating sensory stimulation between a first sensory stimulation ing simultaneously providing a left visual stimulus pattern to a left eye of the user and a right auditory stimulus pattern to the right side of the head; and a second sensory stimulation including simultaneously providing a right visual stimulus pattern to a right eye of the user and a left auditory stimulus pattern to the left side of the head of the user, wherein one or more of the left auditory stimulus pattern or the right auditory stimulus pattern comprises a sequence of stimulus patterns including a first stimulus pattern having a first pulse ncy between 3.75 Hz and 4.25 Hz, a second stimulus pattern having a second pulse frequency between 1.25 Hz and 1.75 Hz, and a third stimulus pattern having a third pulse frequency n 0.25 Hz and 0.75 Hz.

2. The method of claim 1, further comprising: periodically ing a sensory stimulation including simultaneously providing a left visual stimulus pattern to the left eye of the user, a right visual stimulus n to the right eye of the user, a left auditory stimulus pattern to the left side of the head, and a right auditory stimulus n to the right side of the head of the user.

3. The method of claim 2, further sing: ating sensory stimulation between a third sensory stimulation including simultaneously providing a left visual stimulus pattern to the left eye of the user and a left auditory stimulus pattern to the left side of the head, and a fourth sensory stimulation including aneously ing a right visual stimulus pattern to the right eye of the user and a right auditory stimulus pattern to the right side of the head of the user.

4. The method of claim 3, further comprising: alternating sensory stimulation between a fifth sensory stimulation ing simultaneously providing a left auditory stimulus pattern to the left side of the head and a right auditory stimulus pattern to the right side of the head, and a sixth sensory stimulation including aneously providing a left visual stimulus pattern to the left eye of the user and a right visual stimulus pattern to the right eye of the user.

5. The method of claim 1, n the left auditory us pattern comprises generating the left auditory stimulus pattern with a left speaker, and wherein generating the right auditory stimulus pattern comprises generating the right auditory stimulus pattern with a right speaker.

6. The method of claim 1, wherein the left auditory stimulus pattern comprises generating the left ry stimulus pattern with a left bone conduction transducer of a headset, and wherein the right auditory stimulus pattern comprises generating the right auditory stimulus pattern with a right bone conduction transducer of the headset.

7. The method of claim 1, wherein one or more of the left or right auditory us pattern includes an auditory frequency of from 240 Hz to 480 Hz.

8. The method of claim 1, wherein one or more of the left visual stimulus pattern or right visual stimulus pattern comprises repeatedly g a 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 and second frequencies.

9. The method of claim 8, wherein the first frequency is between 3.75 Hz and 4.25 Hz, the second ncy is between 1.25 Hz and 1.75 Hz, and the third frequency is between 0.25 Hz and 0.75 Hz.

10. The method of claim 9, wherein repeatedly pulsing the light comprises pulsing the light for a predetermined time interval.

11. The method of claim 10, wherein the predetermined time al is 25-45

12. The method of claim 1, wherein the sequence of us patterns each have a pulse frequency having a pulse period, where a portion of the pulse period includes a stimulus of an auditory frequency of from 240 Hz to 480 Hz.

13. The method of claim 12, wherein said n of said pulse period is one half of the pulse period.

14. The method of claim 1, wherein said first stimulus pattern, said second stimulus pattern, or said third us n ates for a predetermined time interval.

15. The method of claim 14, wherein the predetermined time interval is 25-35 seconds.

16. The method of claim 15, wherein the predetermined time interval is 30 seconds.

17. A non-therapeutic method of providing performance enhancement using the method of Claim 1.

18. The method of claim 17, where said performance enhancement is ing sleep, the improvement of mental capabilities, or the improvement of physical capabilities, for non-therapeutic purposes.

19. An apparatus to provide stimulation to a user, the apparatus comprising: a frame configured to be worn on a head of the user; 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; a left light source configured to generate a left visual stimulus pattern from said left light source input; a right light source configured to generate a right visual stimulus pattern from said right light source input; a left auditory source configured to generate a left auditory stimulus pattern from said left auditory source input; and a right auditory source configured to generate a right auditory stimulus pattern from said right auditory source input; where said ller is programmed to generate inputs which alternate between a first input including simultaneously ting 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, wherein one or more of the left auditory source input or the right auditory source input comprises a sequence of a stimulus patterns including a first stimulus pattern having a first pulse ncy between 3.75 Hz and 4.25 Hz, a second us pattern having a second pulse frequency between 1.25 Hz and 1.75 Hz, and a third stimulus pattern having a third pulse frequency between 0.25 Hz and 0.75 Hz.

20. The apparatus of claim 19, wherein one or more of the left auditory source or the right auditory source is a speaker.

21. The apparatus of claim 19, n one or more of the left auditory source or the right auditory source is a bone conduction transducer.

22. The tus of claim 19, wherein one or more of the left or right light source comprises a light-emitting diode (LED).

23. The apparatus of claim 22, wherein one or more of the left or right light source is configured to generate light at 550-610 nm.

24. The apparatus of claim 22, wherein one or more of the left or right light source is configured to generate light at 580 nm.

25. A non-therapeutic method of providing performance enhancement ing the apparatus as claimed in any one of claims 19 - 24, said method comprising: providing a headset to be worn by a user; providing a sensory stimulation to the user from the headset, where said stimulation alternates between a first sensory stimulation ing simultaneously providing a left visual stimulus n to a left eye of the user and a right auditory stimulus pattern to the right side of the head, and a second sensory stimulation including aneously providing a right visual stimulus pattern to a right eye of the user and a left auditory stimulus pattern to the left side of the head of the user, wherein one or more of the left auditory stimulus pattern or the right auditory stimulus pattern comprises a sequence of stimulus patterns ing a first stimulus pattern having a first pulse frequency between 3.75 Hz and 4.25 Hz, a second stimulus pattern having a second pulse frequency n 1.25 Hz and 1.75 Hz, and a third stimulus pattern having a third pulse frequency between 0.25 Hz and 0.75 Hz.

26. The method of claim 25, where said performance enhancement is providing sleep, the improvement of mental capabilities, or the improvement of physical capabilities, for non-therapeutic purposes.

27. The apparatus according to any one of claims 19 – 24, wherein the apparatus is ured to provide a first sensory stimulation including simultaneously providing a left visual us pattern to a left eye of the user and a right auditory us pattern to the right side of the head, and a second sensory stimulation including simultaneously providing a right visual stimulus pattern to a right eye of the user and a left auditory stimulus pattern to the left side of the head of the user.

28. The tus according to claim 27, wherein the apparatus is capable of providing performance enhancement, including providing sleep, improvement of mental capabilities, and/or improvement of physical capabilities.

29. The apparatus according to any one of claims 19 – 24, wherein the apparatus is configured to treat, or is capable of treating, a neurological disease or condition.

30. The apparatus of claim 29, wherein the neurological e or condition is selected from the group comprising insomnia, PTSD or brain .

31. The apparatus of claim 29, wherein the apparatus is configured to increase, or is capable of sing, alpha wave activity in the brain.