HK40002584B - Methods and systems for providing stimuli to the brain - Google Patents

Description

Methods and systems for providing stimulation to the brain

Technical Field

The present disclosure relates to medical devices and methods. In particular, the present disclosure relates to providing stimulation to a subject to treat various neurological disorders or conditions and/or to providing physical performance enhancement.

Background Art

Sensory stimulation has been used to treat a variety of disorders. For example, binaural beats have been used to induce various mental states to encourage sleep, relaxation, meditation, creativity, and other desired mental states. Combinations of auditory and visual stimulation have also been used to encourage such mental states. However, in many cases, the application of this therapy is less than ideal. The devices that provide stimulation can be bulky, expensive, often difficult to access, and fall below the critical efficacy threshold for widespread use, typically only helping a subset of the population. In many situations, such as when trying to sleep in a bedroom or on an airplane cabin, users may find it difficult to use such devices.

To treat various neurological disorders and conditions, medications and/or supplements are often used to replace sensory stimulation. However, in many cases, the use of medications may be less than ideal. Typically, medications are 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. For example, to treat insomnia, medications and supplements such as melatonin and zolpidem (Ambien ^™ ) have questionable efficacy. Medications often result in undesirable side effects. For example, some medications used to treat insomnia may result in deprivation of certain deep sleep ranges and an increase in mortality.

For at least these reasons, improved methods and systems for treating neurological disorders and other conditions that overcome at least some of the above-mentioned challenges are desired.

Summary of the Invention

The present disclosure relates to medical devices and methods that can be used, for example, to provide stimulation to a subject in order to treat various neurological disorders or conditions, wherein the stimulation provided can include one or more of auditory stimulation, visual stimulation, or tactile stimulation. Examples of neurological disorders that can be treated using the devices and methods can include, but are not limited to, insomnia, post-traumatic stress disorder (PTSD), brain injury, including but not limited to traumatic brain injury (TBI), mild traumatic brain injury (mTBI), or damage caused by lack of oxygen to the brain due to stroke, depression, anxiety, mood disorders, personality disorders, eating disorders, mental disorders, and balance disorders, to name a few. 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 improving neuroplasticity, motor skills, coordination, reaction time, alertness, energy, working memory, mood, and well-being.

In some embodiments, stimulation may be provided to a wearer of a headset or sleep mask that can be comfortably worn by the user, such as in bed, to induce sleep. The wearable headset or sleep mask may be operated by the user's personal computing device, such as a smartphone, having a control application or "app" for the treatment downloaded and activated thereon. The wearable headset or sleep mask may also simultaneously provide tactile stimulation, and the tactile stimulation may be provided from a bone conduction transducer that may simultaneously provide the auditory stimulation. Various stimulation patterns for inducing different user responses are also disclosed.

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

Thus, for example, an embodiment device generates outputs that can be perceived as stimulation by a user of the device in sequential frequencies (e.g., an alpha wave sequence, a theta wave sequence, and a delta wave sequence). In certain embodiments, the stimulation is coordinated auditory stimulation and visual stimulation, providing pulsed light to the left and right eyes and pulsed hearing to the left and right ears in each of the ranges listed above. As an example, the coordinated stimulation can be: 1) stimulating both eyes and both ears simultaneously; 2) stimulating the left eye and left ear simultaneously, then stimulating the right eye and right ear simultaneously; 3) stimulating both eyes simultaneously, then stimulating both ears simultaneously; or 4) stimulating the right eye and left ear simultaneously, then stimulating the left eye and right ear simultaneously. In each case, the stimulation can include, for example, stimulation in the alpha wave range, then the theta wave range, then the delta wave range. The stimulation can last for a period of one minute to one hour.

In one aspect, a method for providing stimulation to a user is provided. The method includes providing a head-mounted device to be worn by the user; applying a left visual stimulation pattern to the user's left eye using the head-mounted device; applying a right visual stimulation pattern to the user's right eye using the head-mounted device; applying a left auditory stimulation pattern to the left side of the user's head using the head-mounted device; and applying a right auditory stimulation pattern to the right side of the head using the head-mounted device. Application of the left visual stimulation pattern, the right visual stimulation pattern, the left auditory stimulation pattern, and the right auditory stimulation pattern are coordinated with one another.

In another aspect, a method for treating a neurological disease or condition or providing physical enhancement using the method of providing stimulation to a user is provided. The method includes providing a head-mounted device to be worn by the user; applying a left visual stimulation pattern to the user's left eye using the head-mounted device; applying a right visual stimulation pattern to the user's right eye using the head-mounted device; applying a left auditory stimulation pattern to the left side of the user's head using the head-mounted device; and applying a right auditory stimulation pattern to the right side of the head using the head-mounted device. The application of the left visual stimulation pattern, the right visual stimulation pattern, the left auditory stimulation pattern, and the right auditory stimulation pattern are coordinated with each other.

In one aspect, a device for providing stimulation to a user is provided. The device comprises: 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 application of the left visual stimulation pattern, the right visual stimulation pattern, the left auditory stimulation pattern, and the right auditory stimulation pattern are independently controlled but coordinated with each other by the controller.

On the other hand, a method for providing stimulation to a user is provided, the method comprising: at a first time interval, simultaneously providing left-side light stimulation to the left eye of the user, providing right-side light stimulation to the right eye of the user, providing left-side auditory stimulation to the left side of the user, and providing right-side auditory stimulation to the right side of the user; at a second time interval, alternating the provision of the left-side light stimulation and the left-side auditory stimulation with the provision of the right-side light stimulation and the right-side auditory stimulation; at a third time interval, alternating the provision of the left-side light stimulation and the right-side light stimulation with the provision of the left-side auditory stimulation and the right-side auditory stimulation; and at a fourth time interval, alternating the provision of the left-side light stimulation and the right-side auditory stimulation with the provision of the right-side light stimulation and the left-side auditory stimulation.

On the one hand, a method is provided for treating a neurological disease or condition or providing physical function enhancement using the following method: at a first time interval, simultaneously providing left-side light stimulation to the left eye of the user, providing right-side light stimulation to the right eye of the user, providing left-side auditory stimulation to the left side of the user, and providing right-side auditory stimulation to the right side of the user; at a second time interval, alternating the provision of the left-side light stimulation and the left-side auditory stimulation with the provision of the right-side light stimulation and the right-side auditory stimulation; at a third time interval, alternating the provision of the left-side light stimulation and the right-side light stimulation with the provision of the left-side auditory stimulation and the right-side auditory stimulation; and at a fourth time interval, alternating the provision of the left-side light stimulation and the right-side auditory stimulation with the provision of the right-side light stimulation and the left-side auditory stimulation.

On the other hand, a method for providing stimulation to a user is provided, the method comprising: providing a head-mounted device to be worn by the user; applying a left auditory stimulation pattern to the left side of the user's head using the head-mounted device; and applying a right auditory stimulation pattern to the right side of the head using the head-mounted device, the application of the left auditory stimulation pattern and the right auditory stimulation pattern being coordinated with each other.

These features, as well as various ancillary provisions and features that will become apparent to those skilled in the art from the following detailed description, are achieved by the method and system for providing stimulation to a user of the present invention, embodiments of which are illustrated by way of example only with reference to the accompanying drawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

1A and 1B illustrate schematic diagrams of therapeutic systems for providing therapeutic auditory stimulation, visual stimulation, and/or tactile stimulation, according to many embodiments of the present disclosure;

2A and 2B show schematic diagrams of a controller for the therapeutic system of FIG. 1A and FIG. 1B ;

FIG3A illustrates an exemplary therapeutic wearable headgear or sleep mask, in accordance with many embodiments;

FIG3B shows a user wearing the therapeutic wearable headgear and sleep mask of FIG3A ; and

4 illustrates a flow chart of a therapeutic method for providing therapeutic auditory, visual, and/or tactile stimulation, according to several embodiments.

DETAILED DESCRIPTION

FIG1A is a schematic diagram of a first embodiment therapeutic system 100. The therapeutic system 100 provides one or more outputs that a person wearing the therapeutic system can experience as auditory stimulation, visual stimulation, and/or tactile stimulation. Thus, in one embodiment, the therapeutic 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 actions of the light sources and vibration sources. Thus, for example, the therapeutic system 100 may be positioned on the head of a user, wherein the left light source 110L is positioned above the left eye to provide left visual stimulation, the right light source 110R is positioned above the right eye to provide right visual stimulation, the left vibration source 120L is positioned to provide left ear auditory stimulation, and the right vibration source 120R is positioned to provide right ear auditory stimulation.

In one embodiment, the left and right light sources 110L, 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 light to a user at a desired predetermined wavelength or range of wavelengths.

In another embodiment, the left vibration source 120L and the right vibration source 120R may each include an earbud, a small speaker, or other vibration source that can provide auditory stimulation to the user. In certain other embodiments, the left vibration source 120L and the right vibration source 120R may include bone conduction transducers within the audible frequency range to provide vibrations to the user's skull that are sensed by the user's ears as auditory stimulation. Alternatively, one or more of the left vibration source 120L and the right vibration source 120R may also generate vibrations that are sensed as tactile stimulation. Thus, for example, the controller 130 may provide a first signal to the bone conduction transducer that vibrates or oscillates at a first frequency that can be interpreted by the user as auditory stimulation, and may provide a second signal at a second, lower frequency that can be interpreted by the user as a tactile sensation. In other words, the bone conduction transducer can be adapted to provide both auditory stimulation and tactile stimulation to the user.

In some embodiments, the left and right vibration sources 120L, 120R provide output at a specific frequency or frequencies or frequency ranges, and are turned on and off at the stimulation frequency. Thus, for example, the vibration sources can be programmed to provide output at a 256 Hz audio frequency for a certain period of time, and then not output for a subsequent period of time. Thus, the vibration source is the product of the audio frequency and a square wave.

FIG1B is a schematic diagram of a second embodiment therapeutic system 100′. Unless otherwise specified, the second embodiment therapeutic system 100′ is generally similar to the first embodiment therapeutic system 100′. Specifically, the second embodiment therapeutic system 100′ includes a left tactile stimulation source 121L and a right tactile stimulation source 121R, each of which can be individually controlled and coordinated using a controller 130 to provide tactile stimulation to a user of the therapeutic system 100′.

2A and 2B show schematic diagrams of a controller 130 of a therapeutic system 100 or 100'. As shown in FIG2A , the therapeutic system 100 or 100' may optionally include an external control unit 130a that can wirelessly communicate with a wireless receiver/transmitter 130c of the controller 130 via a wireless connection 131a. The wireless connection 131a can include a Bluetooth connection, a Bluetooth LE connection, a WiFi connection, a ZigBee connection, an infrared (IR) connection, a radio frequency (RF) connection, or an inaudible auditory signal connection, to name a few examples. The external control unit 130a can include a customized electronic controller. In many embodiments, the external control unit 130a can include a user's personal computing device that can have a customized computer application or "app" downloaded thereto and operated to operate the system 100 or 100' to provide a therapeutic regimen. For example, the personal computing device may include a personal computer, a personal laptop computer, a tablet computer (e.g., Apple's iPad, Samsung's Galaxy Tab, Microsoft's Surface, or Amazon's Fire, to name a few examples), a smartphone (e.g., Apple's iPhone, Samsung's Galaxy phone, or Google's Nexus phone, to name a few examples), and the customized computer application or "app" may be an application or "app" downloadable from an application distribution platform (e.g., 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 include one or more therapeutic regimens that a user may select to be implemented by the therapeutic system 100 or 100'. In some embodiments, the application may allow a user to provide feedback on the effectiveness of the therapeutic regimen(s), which feedback may be uploaded and collected by a central server(s) in communication with the application, and the therapeutic regimen(s) may be improved or optimized based on the feedback from the one or more users. Alternatively or in combination, as shown in Figure 2B, the system 100 or 100' can further include an external control unit 130a (e.g., a custom controller) that can communicate with the controller 130 via a wired connection 131a (e.g., a USB, FireWire, or Lightning connection, to name a few examples).

3A shows one embodiment of the therapeutic system 100 as including a therapeutic wearable head-mounted device or sleep mask 140 that integrates a light source, a vibration source, and an optional tactile source into a single form factor for presentation to the user. Thus, for example, when the user places the wearable head-mounted device or sleep mask 140 on their head, the left light source 110L is positioned above the left eye to provide left visual stimulation, the right light source 110R is positioned above the right eye to provide right visual stimulation, the left vibration source 120L is positioned to provide auditory stimulation to the left ear, and the right vibration source 120R is positioned to provide auditory stimulation to the right ear.

As discussed above and herein, the left vibration source 120L and the right vibration source 120R can each include a bone conduction transducer that can provide both auditory and tactile stimulation. Alternatively, the wearable headgear 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 can be individually controlled and coordinated using the controller 130, as described above with respect to FIG. 1B .

As discussed above and herein, for example, the therapeutic wearable headgear or sleep mask 140 can operate with an external controller 130a (e.g., a smartphone) that communicates with the controller 130 via a wireless connection 131a. For example, the user US can have the option to turn tactile stimulation on or off. FIG3B shows the user US wearing the therapeutic wearable headgear or sleep mask 140.

FIG4 shows a flow chart of an exemplary therapeutic method 400 for providing therapeutic auditory stimulation, visual stimulation, and/or tactile stimulation. In step 410, a subject with a neurological disorder or condition may be identified. Examples of neurological disorders may include, but are not limited to, insomnia, post-traumatic stress disorder (PTSD), brain injury (e.g., traumatic brain injury (TBI), mild traumatic brain injury (mTBI), or damage caused by lack of oxygen to the brain due to conditions such as stroke, depression, anxiety, mood disorders, personality disorders, eating disorders, and mental disorders). Alternatively, a subject may be selected for therapeutic method 400 for the purpose of enhancing physical function of mental and/or physical tasks to assist the subject in taking a nap or sleeping. In step 420, a therapeutic system or headgear, such as the system 100 or 100 ′ described above, may be provided to the subject. In step 430, the subject may wear the therapeutic system or headgear, such as a wearable headgear or sleep mask 140. In step 440, the headset 140 executes the programming 450 provided in the controller 130 to provide stimulation to the subject. The programming provides for the headset 140 to simultaneously provide two or more of auditory stimulation, visual stimulation, and/or tactile stimulation to the subject, and thus, for example, power may be provided to activate the left light source 110L, the right light source 110R, the left vibration source 120L, and/or the right vibration source 120R.

As discussed above and herein, the left vibration source 120L and the right vibration source 120R can each include a bone conduction transducer that can provide both auditory and tactile stimulation. Alternatively, the wearable headgear 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 can be individually controlled and coordinated using the controller 130, as described above with respect to FIG. 1B .

In some embodiments, providing two or more of the auditory stimulation, video stimulation, and/or tactile stimulation simultaneously can provide an improved therapeutic benefit compared to providing only one of the auditory stimulation, video stimulation, and/or tactile stimulation at a time. For example, these two or more auditory stimulation, video stimulation, and/or tactile stimulation can therefore be combined to provide an improved therapeutic benefit (i.e., these two or more auditory stimulation, video stimulation, and/or tactile stimulation can act synergistically in a manner that provides an improved result over providing both stimulations separately).

For example, exemplary instructions for providing stimulation can be provided by programming 450, such as subroutine 450a, which includes activating all effective auditory stimulation sources, video stimulation sources and/or tactile stimulation sources simultaneously. Alternatively, activating all sources can include activating tactile stimulation to run through all subsequent auditory stimulation and/or visual stimulation. Another exemplary subroutine 450b can include alternating left auditory stimulation source, video stimulation source and/or tactile stimulation source with right auditory stimulation source, video stimulation source and/or tactile stimulation source (i.e., left stimulation and right stimulation are activated in turn). Another exemplary subroutine 450c can include alternating visual source with auditory source and/or tactile source (i.e., visual stimulation and auditory/tactile stimulation are activated in turn). Another exemplary subroutine 450d can include alternating left auditory source and/or tactile source and right visual source with right auditory source and/or tactile source and left visual source (i.e., opposite auditory/tactile stimulation is activated in turn). This programming is further described below.

In step 440, programming 450, including but not limited to subroutines 450a, 450b, 450c, and 450d, can be applied one or more times, individually or in combination. Furthermore, the programming can provide the output sequences within subroutines 450a, 450b, 450c, and 450d at different frequencies and/or timings. Thus, for example, a subroutine can provide an output at a specific frequency that changes as the subroutine is repeated. Thus, for example, subroutine 450a can provide an auditory output to vibration source 120R or 120L that is turned on and off at a frequency of 256 Hz. That is, the vibration source is pulsed at a pulse frequency of 1 Hz for two minutes. Thus, in addition to higher harmonics, this square wave pulsed auditory signal generates a signal at a frequency of 1 Hz. Subsequently, the 256 Hz output is pulsed at twice the previous pulse frequency for two minutes. In this way, the 256 Hz auditory frequency can be modulated over a wide range, including frequencies corresponding to brainwave frequencies.

Furthermore, by altering the output between the left and right channels, the brain can be stimulated in a way that forces communication between the left and right sides of the brain. For example, this forced communication could allow PTSD memories to be connected to both sides of the brain, thereby preventing unwanted pathological recurrence.

While the above steps illustrate a method 400 for treating a patient according to an embodiment, those skilled in the art will recognize numerous variations based on the teachings described herein. The steps may be performed in a different order. Steps may be added or deleted. Some of these steps may include sub-steps. Many of these steps may be repeated as often as is beneficial for treatment.

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

Example 1

Described below are examples of stimulation patterns that empirical studies have found to be effective for inducing sleep (including naps), enhancing neuroplasticity, treating brain injury due to stroke, TBI, or mTBI, improving balance (including improving fine motor control and reaction time), and treating PTSD, to name a few indications.

Light stimulation and auditory stimulation of a first frequency can be provided in a first time segment, then a second, lower frequency can be provided in a second time segment, and then a third, lower frequency can be provided in a third time segment. For example, each time segment can include one or more sub-segments of light stimulation and auditory stimulation, each sub-segment including one of the above-mentioned subroutines. Light stimulation and auditory stimulation can end after a predetermined time period (such as 20 minutes). Light stimulation and auditory stimulation can be rebounded (i.e., starting from the third frequency, then transitioning to the second frequency, and finally transitioning to the third frequency), such as in order to wake up the user. Alternatively or in combination, light stimulation and auditory stimulation can be maintained at the second frequency, such as in order to maintain the user's sleep state. As described above, tactile stimulation can be provided simultaneously with auditory stimulation. Light with a wavelength of 580nm can be provided, and hearing with a frequency of 256Hz can be provided, or any one or a combination of a plurality of auditory frequencies that the subject can select according to his or her wishes.

Table 1 below describes an exemplary treatment regimen for this example. The stimulation provided in Table 1 first cycles through four blocks of Segment A outputs, then cycles through four blocks of Segment B outputs, then cycles through seven blocks of four Segment C outputs, and finally repeats the four blocks of Segment A outputs. For Segment A outputs (A1, A2, A3, and A4), the auditory output and light output cycle 115 or 116 times between turning on for 0.1277 seconds and then turning off for 0.1277 seconds (i.e., at a pulse frequency of 3.9 Hz), and then not output for 0.5 seconds. For Segment B outputs (B1, B2, B3, and B4), the auditory output and light output cycle 44 or 45 times between turning on for 0.3333 seconds and then turning off for 0.3333 seconds (i.e., at a pulse frequency of 1.5 Hz), and then not 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 off for 1 second (i.e., at a pulse frequency of 0.5 Hz), followed by no output for 1 second. Segments A1, B1, and C1 pulse both the right and left sides of the light and auditory outputs together, with all outputs synchronized to be on or off simultaneously, as provided by subroutine 450a. Segments A2, B2, and C2 synchronize the left light and auditory outputs to be opposite to the right light and auditory outputs, as provided by subroutine 450b. Segments A3, B3, and C3 synchronize the two lights together to be opposite to the two auditory outputs, as provided by subroutine 450c. Segments A4, B4, and C4 synchronize the right auditory and light outputs to be opposite to the left auditory and light outputs, as provided by subroutine 450d.

Table 1

Example 2

The following describes an example of a stimulation pattern that empirical studies have found to be effective for inducing sleep. The stimulation pattern of Example 2 includes a portion of the treatment protocol shown in Table 1. Specifically, the stimulation first cycles through four blocks of Segment A output, then cycles through four blocks of Segment B output, and then cycles through seven blocks of four Segment C outputs. The repetition of the last four blocks of Segment A output is not provided in Example 2.

Example 3

Described below are examples of stimulation patterns that empirical studies have found to be effective for enhancing alpha wave brain activity, inducing neuroplasticity, treating stroke or other brain injuries (such as TBI or mTBI), including improving balance, improving fine motor control and reaction time, and treating PTSD, to name a few indications.

In this example, the four subroutines described above and herein are applied and repeated over multiple time segments, each subroutine being performed at a predetermined stimulation (repetition) frequency. For example, the four subroutines can be repeated, for example, with each segment of the four subroutines lasting 120 seconds. As described above, tactile stimulation can be provided simultaneously with auditory stimulation. Light having a wavelength of 580 nm can be provided, and hearing having a frequency of 432 Hz can be provided.

Table 2 below describes an exemplary treatment protocol for this example. The stimulation provided in Table 2 is cycled 10 times through the four Segment A output blocks. For Segments A1, A2, A3, and A4, the auditory and light outputs cycle 115 or 116 times between being on for 0.1277 seconds and then off for 0.1277 seconds, followed by no output for 0.5 seconds. Segment A1 pulses both the right and left sides of both the light and auditory outputs together, with all outputs synchronized to be on or off simultaneously, as provided by subroutine 450a. Segment A2 synchronizes the left light and auditory outputs to be opposite to the right light and auditory outputs, as provided by subroutine 450b. Segment A3 synchronizes both lights together to be opposite to the two auditory outputs, as provided by subroutine 450c. Segment A4 synchronizes the right auditory and light outputs to be opposite to the left auditory and light outputs, as provided by subroutine 450d.

Table 2

Example 4

Described below is another example of a stimulation pattern, which has been found in empirical studies to be effective in enhancing the energy level of a subject. Light stimulation and auditory stimulation of a first frequency may be provided over a first time segment, followed by a second, higher frequency over a second time segment, and then back to the first frequency over a subsequent time segment, and so on. For example, each time segment may include one or more subsegments of light stimulation and auditory stimulation, each of which includes one of the above-mentioned subroutines. Light stimulation and auditory stimulation may end after a predetermined time period (such as 20 minutes). As described above, tactile stimulation may be provided simultaneously with auditory stimulation. Light with a wavelength of 580 nm may be provided, and hearing with 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 is first cycled ten times through four Segment A output blocks and then through four Segment D output blocks. For Segment A outputs (A1, A2, A3, and A4), the auditory and light outputs cycle 115 or 116 times between being on for 0.1277 seconds and then off for 0.1277 seconds, and then not outputting 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 off for 0.0667 seconds, and then not outputting for 0.5 seconds. Segments A1 and D1 pulse modulate both the right and left sides of both light and hearing, with all outputs synchronized to be on or off simultaneously, as provided by subroutine 450a. Segments A2 and D2 synchronize the left light and auditory outputs to be opposite to the right light and auditory outputs, as provided by subroutine 450b. Segments A3 and D3 synchronize the two lights together in opposition to the two auditory outputs, as provided by subroutine 450c. Segments A4 and D4 synchronize the right auditory and light output in opposition to the left auditory and light output, as provided by subroutine 450d.

Table 3

Example 5

Table 4 below lists the results of experiments using the methods of the present invention. The table lists the condition being tested or treated, details of the condition, the number of subjects, and the test results. In each case, stimulation was used in Example 1 for treating non-sleep-related problems and for inducing short sleep, while stimulation in Example 2 was used for all other treatments.

Some treatments provide improvements in physical and/or mental performance, such as improved fine motor control and reaction time. This may be due to the improved neural remodeling provided by the device in the days following treatment. Other treatments provide improvements in performing tasks and recovering from brain injuries—such as those caused by oxygen deprivation (as seen in stroke and in those with traumatic brain injury (TBI) or mild traumatic brain injury)—and can provide improved balance and improved fine motor control. Other treatments provide relief for patients with PTSD by reducing their response to triggering stimuli.

Table 4

Although 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. Without departing from the present invention, those skilled in the art will now make many changes, variations, and substitutions. It should be understood that different alternatives to the embodiments of the present invention described herein may be used to practice the present invention. The following claims are intended to define the scope of the present invention and therefore cover methods and structures within the scope of these claims and their equivalents.

It should be understood that the present invention includes all different combinations embodied herein. Throughout this specification, the term "comprising" should be synonymous with "including," "containing," or "characterized by," is inclusive or open-ended, and does not exclude additional, undescribed elements or method steps. "Comprising" is a term of art that means that the specified elements are essential, but other elements can be added and still form a construction within the scope of the claim. "Comprising" also includes unspecified ingredients, even if the number is large.

Claims (6)

1. An apparatus for providing stimulation to a user, the apparatus comprising: The frame is configured to be worn on the user's head; The controller is programmed to generate multiple 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 is configured to generate a left visual stimulation pattern by inputting the left light source into the user's left eye; A right light source is configured to generate a right visual stimulation pattern for the user's right eye by input from the right light source. A left auditory source is configured to generate a left auditory stimulation pattern from input to the user's left ear; and A right auditory source is configured to generate a right auditory stimulation pattern from input to the user's right ear; The controller is programmed to generate multiple inputs, which alternate between a first input and a second input. The first input includes simultaneously generating the left light source input and the right auditory source input, and the second input includes 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 include a sequence of stimulation patterns, the sequence of stimulation patterns including a first stimulation pattern having a first pulse frequency between 3.75 Hz and 4.25 Hz, a second stimulation pattern having a second pulse frequency between 1.25 Hz and 1.75 Hz, and a third stimulation pattern having a third pulse frequency between 0.25 Hz and 0.75 Hz. 2. The apparatus of claim 1, wherein one or more of the left auditory source or the right auditory source is a loudspeaker. 3. The device of claim 1, wherein one or more of the left auditory source or the right auditory source are bone conduction transducers. 4. The apparatus of claim 1, wherein one or more of the left light source or the right light source comprises a light-emitting diode (LED). 5. The apparatus of claim 4, wherein one or more of the left light source or the right light source are configured to generate light in the range of 550 nm to 610 nm. 6. The apparatus of claim 4, wherein one or more of the left light source or the right light source are configured to generate light at 580 nm.