WO2018013835A1

WO2018013835A1 - Wearable devices, systems, and methods for balancing and maintaining autonomic nervous system health

Info

Publication number: WO2018013835A1
Application number: PCT/US2017/041972
Authority: WO
Inventors: G. Blake HOLLOWAY; Christopher Gross
Original assignee: Solace Lifesciences, Inc.
Priority date: 2016-07-13
Filing date: 2017-07-13
Publication date: 2018-01-18
Also published as: WO2018013835A4

Abstract

The inventive subject matter provides a wearable device for application of methods for balancing and maintaining the health of the human autonomic nervous system, including a wearable frame; cranio-electrical stimulation (CES) circuitry and electrodes positioned on the wearable frame; and optionally including audio entrainment with binaural beats circuitry and audio outputs, and an attachable visual mask containing light-blocking material and frequency-following response visual stimulation circuitry and lights. The device may also include sensors to monitor various physiologic indicators. The system communicates the physiologic data with other devices (such as smart phones or tablets) that have algorithms to interpret the data to determine whether additional therapy is required. Based on this feedback, the smart phone communicates with the therapy elements, e.g., CES, to continue or discontinue therapy.

Description

WEARABLE DEVICES, SYSTEMS, AND METHODS FOR BALANCING AND MAINTAINING AUTONOMIC NERVOUS SYSTEM HEALTH

[0001] This application claims priority to 62/361905, filed July 13, 2016. All extrinsic materials identified herein are incorporated by reference in their entirety.

Field of the Invention

[0002] The field of the invention is devices, systems, and methods for anxiety reduction designed to lower sympathetic nervous system arousal in a person. The inventive subject matter relates more specifically to wearable devices for the application of these systems and methods.

Background

[0003] The background description includes information that may be useful in understanding the inventive subject matter. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art. The full disclosures of U.S. Patent No. 9,079,030; Registered July 14, 2015 and U.S. Patent Application Publication No. US 2011/0223150; Publication Date September 15, 2011 are incorporated herein by reference.

[0004] Many individuals suffer from fear and anxiety when exposed to stressful situations.

These anxiety-inducing situations range from common every day experiences such as traffic jams, job deadlines, and medical and dental treatments, to more severe stressors such as relocation, divorce, and loss of loved ones. Some individuals suffer from heightened fears and anxiety due to more complicated conditions including PTSD and phobias. Therapies exist to provide relief from anxiety by rapidly lowering sympathetic nervous system arousal. Many of these therapeutic systems require equipment that is stationary and cumbersome.

[0005] It would be desirable, therefore, to have a system that is portable, lightweight, responsive, and convenient. It would also be desirable to have a system that takes advantage of audio devices and smart phone or tablet devices that are commonly utilized by the population. In addition, some efforts have been made to provide personalized treatments based upon

biofeedback of physiologic indicators. However, these systems generally require a great deal of equipment and tend to be cumbersome and plodding as well. Thus, there is still a need for cranio-electrical stimulation (CES) devices that are easy to wear and use. Preferably, CES devices include a removable mask to block light, and can be used with audio entrainment- binaural beats administered via the user's ear buds/headphones and an app installed on the user's mobile phone (or tablet).

[0006] All publications identified herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.

Summary of The Invention

[0007] The inventive subject matter provides devices, systems and methods that utilize cranio- electrical stimulation (CES), audio entrainment with binaural beats, and optionally a visual mask to provide light-blocking or frequency-following response. Specifically, the inventive subject matter discloses wearable devices for the application of these systems and methods.

Technologies have developed to the point where physiologic characteristics can be measured by non-invasive methods using a variety of components and sensors that can be incorporated into the system. The inventive subject matter may interact with other devices to measure these physiologic indicators and adjust therapies accordingly to achieve results which are specific and desirable for the individual based upon the feedback received by the system.

[0008] The inventive subject matter provides an easy-to-use wearable device system and method that allows the user to quickly put the components in place and receive therapy. Contemplated systems may be used to monitor various physiologic indicators by means of sensors positioned on the wearable device. Such systems can communicate the physiologic data to other devices (such as smart phones or tablets) that have algorithms to interpret the data to determine whether additional therapy is required. Based on this feedback, the smart phone communicates with the therapy elements, e.g., CES, to continue or discontinue therapy. Thus, the inventive subject matter not only provides quick and convenient treatment but also allows the user to interact with other devices to receive personalized interventions. [0009] As used in the description herein and throughout the claims that follow, the meaning of "a," "an," and "the" includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of "in" includes "in" and "on" unless the context clearly dictates otherwise.

[0010] All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. , "such as") provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[0011] In some embodiments, an optional light blocking shade or other shades are used to block computer screen or television light to promote better sleep patterns. It is also contemplated to optionally provide a light montage to stimulate a frequency-following response on the visual cortex that is synchronized with the binaural beats in the audio entrainment program.

[0012] Some contemplated wearable devices provide an on/off power button and two modes of operation: relax or focus. Such devices can utilize a smart device app, which could operate on IOS, android, or any other suitable operating system. Preferably, a user can choose a preferred head set, ear buds, etc. as well as Bluetooth or WiFi. Such flexibility is intended to provide low cost, simple, and comfortable treatment options.

[0013] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.

Brief Description of the Drawing

[0014] Fig. 1 is a schematic block diagram showing some of the therapy or treatment components of a preferred inventive system.

[0015] Fig. 2 is a schematic block diagram disclosing some contemplated sensor elements for obtaining physiologic data of the inventive subject matter. [0016] Fig. 3A is a right side profile view of an embodiment of the wearable device of the inventive subject matter positioned on a user.

[0017] Fig. 3B is a left side profile view of an embodiment of the device of Fig. 3A, as positioned on the user.

[0018] Fig. 4A is a perspective view of another embodiment of the wearable device of the inventive subject matter.

[0019] Fig. 4B is a perspective view of the device of Fig. 4 A, with light-blocking eye shades.

[0020] Fig. 5 is a flowchart disclosing exemplary steps for implementation of therapy, using systems and methods of the inventive subject matter.

[0021] Fig. 6 is a flowchart disclosing exemplary steps for implementation of therapy with biofeedback, using the systems and methods of the inventive subject matter.

[0022] Fig. 7 A shows an electrical stimulation device frame and electrode.

[0023] Fig. 7B shows the electrical stimulation device of Fig. 7A with an eye mask.

[0024] Fig. 7C shows the foam support of the electrical stimulation device of Figs. 7 A & B.

Detailed Description

[0025] The following description includes information that may be useful in understanding the inventive subject matter. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

[0026] The inventive subject matter provides a wearable device for application of systems and methods for anxiety reduction designed to lower sympathetic nervous system arousal in a person. The system and method of the inventive subject matter utilizes cranio-electrical stimulation (CES), and optionally one or more of audio entrainment with binaural beats, and a visual mask to provide light-blocking or frequency-following response. The inventive subject matter also includes wearable devices for the application of these systems and methods, as well as measurement of physiologic characteristics. Such physiologic indicators can be measured by non-invasive methods using a variety of components that can be incorporated into the system, or the system may interact with other devices that transmit data for various physiological indicators and adjust therapies accordingly to achieve results which are specific and desirable for the individual based upon the feedback received by the system.

[0027] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually, or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the

specification is herein deemed to contain the group as modified, thus fulfilling the written description of any Markush groups used in the appended claims.

[0028] Reference is made first to Fig. 1, which is a schematic block diagram showing the therapy or treatment components of an exemplary wearable device system 10 of the inventive subject matter. Fig. 1 presents wearable device frame 12 (also referred to as a "frame") containing CES circuitry and battery 20 and the right and left CES patches 18a and 18b. The CES circuitry and battery 20 is connected to the right and left CES patches 18a and 18b by wearable device frame 12. Wearable device frame 12 may be attached to visual mask 14 (also referred to as an "eye mask") by any of a variety of attachment mechanisms 16, such as magnets or clips. Thus, the eye mask is removably coupled to the frame. As used herein, the term

"removably" means that the eye mask can be removed and coupled to the frame in a nondestructive manner. Visual mask 14 may be a simple light-blocking mask, or may optionally include visual stimulator components such as LED lights. Fig. 1 shows right and left visual stimulator components 26a and 26b as well as visual stimulator circuitry and battery 28. The visual stimulator components 26a and 26b may be wired through the visual mask 14 or may receive signals wirelessly. The audio circuitry and battery component 24 is optional and may or may not be used. The simplest configuration would be wired, as is shown with audio signal line 30 which connects audio circuitry and battery component 24 to the right and left audio outputs 22a and 22b. The right and left audio outputs 22a and 22b may alternatively be wireless. The wearable device system 10 of the inventive subject matter may be totally self-contained, or may utilize a Smart Phone or Tablet with Bluetooth and/or WiFi 32 for communication with circuitry elements 20, 24, and 28 of wearable device system 10.

[0029] Although frame 12, shown in Fig. 1, is configured to be worn across a human user' s forehead and behind the human' s ears, the inventors contemplate that suitable frames include headbands, or other designs. Additionally, to treat pet anxiety, frames and CES systems can be designed to fit dogs, cats, etc.

[0030] Fig. 2 presents a schematic block diagram disclosing some of the sensor elements for obtaining physiologic data that can be used with the wearable device system 10 of the inventive subject matter. It will be understood by one skilled in the art that the components disclosed in Fig. 2 may be incorporated in miniature form in wearable frame 12 and visual mask 14 shown in Fig. 1. As shown in Fig. 2, wearable device frame 12 may contain a variety of sensors for the measurement of physiologic indicators. Fig. 2 reveals a preferred embodiment containing sensors that include EEG circuitry and battery 36 and EEG electrodes 34a and 34b. There may be a plurality of EEG electrodes. Further disclosed in Fig. 2 are temperature sensor 40, skin conductivity electrode 42, pulse sensor 44 (e.g. , a blood volume pulse sensor), respiration rate sensor 38, and Laser Doppler Velocimeter (LDV) sensor 46. These various sensor components are known in the art and may be implemented in more than one manner. For example, the respiration rate sensor 38 may be an acoustic sensor such as a piezo-electric microphone, which is positioned near the nasal airway. The temperature sensor 40 may be an in-ear infrared light sensor or other temperature-measuring sensor. The skin conductivity electrode 42 may be an electric contact pad. The pulse sensor 44 may be a light sensor positioned near the temporal artery. The LDV sensor 46 may be a transmitting or reflective light sensor laser diode.

[0031] Continuing in Fig. 2, the multi-sensor circuitry and battery 48 may be structurally connected to wearable device frame 12. The visual mask 14 may be removably attached to wearable device frame 12 by magnets, clips, or the like. The visual mask 14 contains the eye motion sensor circuitry and battery 52 and the right and left eye motion sensors 50a and 50b. The eye motion sensors 50a and 50b may contain infrared LED's having photo diode sensors or receptors to measure reflected light. Also shown in Fig. 2 are electrocardiogram (ECG) electrode(s) 54 which in one embodiment may be configured as a two-pad ECG measuring device positioned on the neck or other location on the user to wirelessly deliver physiologic data. Wireless communication with a Smart Phone or Tablet 32 may be utilized to transmit data between the various sensors of wearable device system 10 and the circuitry components (36, 48, 52, and 54) of the system. This data may be interpreted by software programs contained on the wearable device system 10 or on the Smart Phone or Tablet 32.

[0032] Fig. 3A discloses a right side profile view of a preferred embodiment of a wearable device system 60 of the inventive subject matter. Fig. 3B shows the left side profile view of wearable device system 60. Temple 62a joins temple 62b to provide support over the ears of the user with temple tips 64a and 64b. Also shown are nose supports 66a and 66b. Fig. 3A

discloses CES circuitry and battery 68 and CES patch 70. Fig. 3B shows CES arm 74 and CES patch 76. Magnetic attachment points 72a and 72b, shown in Fig. 3A and Fig. 3B, are used to connect the light-blocking mask to temples 62a and 62b. Wearable device system 60 is designed to provide a lightweight structure that is comfortable to wear and simple to use.

[0033] Fig. 4A provides a perspective view of a preferred embodiment of wearable device 80 of the inventive subject matter. Fig. 4B provides the same perspective view of wearable device 80 with light-blocking eye shades 98 attached. Fig. 4A discloses temples 82a and 82b having temple tips 84a and 84b along with nose supports 86a and 86b. CES circuitry and battery 88 is shown attached to temple 82a. CES patch 90 is shown on CES circuitry and battery 88. CES patch 96 are shown on CES tab 94. Fig. 4A shows magnetic attachment points 92a and 92b positioned on temples 82a and 82b. These magnets hold the light-blocking mask 98 in place as shown in Fig. 4B. The light-blocking mask 98 may optionally contain infrared LED's with photo diode sensors or receptors. LED lights 93 are located between magnetic attachment points 92a and 92b to indicate when power is turned on.

[0034] The basic frame and attachable mask structure of Figs. 3A, 3B, 4A, and 4B can be configured to incorporate some or all of the elements referenced in Fig. 1 and Fig. 2. Multiple structural embodiments of the wearable frame and light-blocking mask are envisioned.

[0035] Fig. 5 is a flowchart disclosing exemplary steps for implementation of therapy using the system and method of the inventive subject matter. Steps 100, 102, and 104 illustrate the beginning of the therapeutic session (steplOO), provision of the wearable therapy device (step 102), as well as provision of Smart Phone or Tablet application software (step 104). The application software is programmed with the personal therapy parameters of the user (step 106). Topical anxiolytic agent of ingestible neurotransmitter supplements are applied to or ingested by the user (step 108). Exemplary anxiolytic agents include gamma-aminobutyric acid (GABA), L- theanine, beta-phenyl-gamma-aminobutyric acid (Phenibut), and casein tryptic hydrolase. See e.g., U.S. Patent Pub. No. 2011/0223150. The topical anxiolytic agent can also be formulated and provided as an adhesive bio-frequency chip. The wearable device is positioned on the user (step 110) and the light-blocking mask is attached to the wearable device frame (step 112). Then the audio output device is put in place on the user (step 114). Signal communication is established between the therapy devices and the Smart Phone or Tablet via Bluetooth or WiFi (step 116) and the application software programming is initiated (step 118).

[0036] As shown in Fig. 5, the various therapies are directed to the user through the system devices (step 120). CES is administered through the wearable device frame (step 120a).

Neuroacoustic entrainment (NAE) is administered through the audio output device (step 120b). Visual stimuli (VS) are administered through the visual stimulator device (step 120c). If the user determines that the therapy session is not complete, the therapies are continued (step 122). If the therapy session is complete, the CES, NAP (neuroacoustic entrainment program), and VS therapies are terminated (step 124). The application software is terminated and the therapy devices are removed from the user (step 126) and the personal therapy session is ended (step 128).

[0037] Fig. 6 is a flowchart disclosing exemplary steps for implementation of therapy with biofeedback using the system and method of the inventive subject matter. In Fig. 6, the personal therapy session is started with biofeedback (step 200). Wearable therapy devices with integrated biosensors are provided to the user (step 202) along with a Smart Phone or Tablet containing application software (step 204). The application software is programmed with personal therapy parameters and biosensor trigger points (step 206). Topical anxiolytic agent is applied to the user and/or neurotransmitter supplements are ingested by the user (step 208). For example, the user can open a bio-frequency chip package and apply the sticky side to the user's skin.

Wearable devices having integrated biosensors are positioned on the user (step 210). Signal communication is established between the wearable devices and the Smart Phone or Tablet via Bluetooth or WiFi (step 212). The application software programming and sensor input is initiated (step 214). The background and baseline therapies are initiated and maintained (step 216) and biofeedback is monitored (step 218). In step 218, data from the various sensors is received, monitored, and analyzed to determine the physiologic state of the user. For example, the system will monitor and analyze EEG signals (step 218a), monitor pulse (e.g. , using a blood volume pulse sensor), electrodardiogram, respiration, temperature, and skin conductivity (step 218b), monitor and analyze cardio (ECG) and blood flow (LDV) signals (step 218c), and monitor eye motion (step 218d).

[0038] If the session is complete (step 220) and no biosensors are triggered (step 222), then the application software is terminated and the wearable devices are removed (step 228) and the personal therapy session is ended (step 230). If the therapy session is complete but a biosensor is triggered (step 222), then therapy is initiated or modified in response to the trigger(s)

(step 224). When the session is complete (step 226), the application software is terminated and the wearable devices are removed (step 228) and the personal therapy session is ended

(step 230).

[0039] Although the inventive subject matter has been described in conjunction with a number of preferred embodiments, those skilled in the art will recognize modifications to these embodiments that still fall within the scope of the inventive subject matter. The inventive subject matter may be implemented through the manufacture and sale of a fully self-contained wearable device system. Alternately, the wearable device system may be partially self-contained and configured to communicate with a variety of external devices and measurement instruments. Thus, various configurations of the inventive subject matter are anticipated.

[0040] The inventive subject matter further includes an electrical stimulation device for modulating an autonomic nervous system of a user. The electrical stimulation device includes a frame, an electrode configured to deliver an electric stimulus to the skin of the user, a power source mechanically coupled to the frame and electrically coupled to the electrode, a sensor configured to detect an autonomic nervous system metric; and a controller configured to control the power and/or the duration of the electric stimulus based on the autonomic nervous system metric. [0041] Sensors can include, but are not limited to, temperature sensors, pulse sensors (e.g. , a blood volume pulse sensor), LDVs, ECG electrodes, and respiration rate sensors. Accordingly, the autonomic nervous system metric obtained from a temperature sensor can comprise a temperature of the user. The autonomic nervous system metric obtained from a pulse sensor can comprise a heart rate of the user. The autonomic nervous system metric obtained from a LDV can comprise a blood flow rate, a blood volume amplitude, and/or a pulse transit time of the user. The autonomic nervous system metric obtained from an ECG electrode can comprise an electrocardiogram. And the autonomic nervous system metric obtained from a respiration rate sensor can comprise a respiration rate.

[0042] For example, the sensor of the electrical stimulation device can comprise an

electroencephalogram (EEG) electrode, and the autonomic nervous system metric can comprise an EEG of the user's brain activity. The EEG may show brain wave patterns, such as, beta, alpha, theta, or delta brainwaves. In some embodiment, detection of waking seizures is desirable. Depending on the target brain state (e.g. , relaxation associated with alpha/theta brain waves), the controller adjusts the duration and/or power of the electric stimulus to guide brain activity to the desired state.

[0043] In another example, the sensor of the electrical stimulation device can comprise a skin conductivity electrode, and the autonomic nervous system metric can comprise a conductance (or resistance) of the user's skin. If the conductance corresponds to an anxious state, the controller adjusts the duration and/or power of the electric stimulus, and optionally the binaural beat frequency pattern, to guide brain activity to a calm/relaxed state.

[0044] Fig. 7 A shows a perspective view of an embodiment of an electrical stimulation device 780. Fig. 7B provides the same perspective view of electrical stimulation device 780 with eye mask 798 coupled to the frame. The frame includes portions 782 and 784. Portion 782 is configured to be worn across a human user's forehead, and portions 784 are configured to be worn behind the human's ears. Also shown is foam support 786. Fig. 7C shows an interior view of foam support 786. Compartment 788 is configured to retain the power source and controller. Electrode 790 is coupled to the frame via arm 774. Advantageously, electrical stimulation device 780 provides a lightweight structure that is comfortable to wear and simple to use. [0045] Fig. 8A provides a side view of electrode 890 and arm 774. Electrode 890 includes a soft contact to comfortably contact the skin of users having a range of head sizes. To further increase flexibility and comfort, arm 774 can include hinge 776 as shown in Fig. 8B. In one embodiment of the inventive subject matter, electrode 890 can both deliver an electric stimulus to the skin of the user and serve as any of the sensor electrodes described herein.

[0046] Any of the electrical stimulation devices according to the inventive subject can be combined with an audio system configured to entrain the user's brain waves with a binaural beat to form a system for modulating the autonomic nervous system.

[0047] In yet further aspects of the inventive subject matter, a method of modulating the autonomic nervous system includes steps of providing an electrical stimulation device as described herein and providing software for the user to install on the user's mobile phone or tablet. When the software (app) is installed on the user's phone or tablet, the software app is configured to play binaural audio that entrains the user's brain waves. Preferably, an anxiolytic agent is also provided to the user. Anxiolytic agents can be formulated as topical anxiolytic agents, bio-frequency chips, and/or oral anxiolytic agents.

[0048] It should be noted that any language directed to a computer should be read to include any suitable combination of computing devices, including servers, interfaces, systems, databases, agents, peers, engines, controllers, or other types of computing devices operating individually or collectively. One should appreciate the computing devices comprise a processor configured to execute software instructions stored on a tangible, non-transitory computer readable storage medium (e.g., hard drive, solid state drive, RAM, flash, ROM, etc.). The software instructions preferably configure the computing device to provide the roles, responsibilities, or other functionality as discussed below with respect to the disclosed apparatus. In especially preferred embodiments, the various servers, systems, databases, or interfaces exchange data using standardized protocols or algorithms, possibly based on HTTP, HTTPS, AES, public-private key exchanges, web service APIs, known financial transaction protocols, or other electronic information exchanging methods. Data exchanges preferably are conducted over a packet- switched network, the Internet, LAN, WAN, VPN, or other type of packet switched network. [0049] The preceding discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.

[0050] As used herein, and unless the context dictates otherwise, the term "coupled to" is intended to include both direct coupling (in which two elements that are coupled to each other contact each other) and indirect coupling (in which at least one additional element is located between the two elements). Therefore, the terms "coupled to" and "coupled with" are used synonymously.

[0051] It should be apparent to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the appended claims. Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. Where the specification claims refers to at least one of something selected from the group consisting of A, B, C .... and N, the text should be interpreted as requiring only one element from the group, not A plus N, or B plus N, etc.

Claims

CLAIMS What is claimed is:

1. An electrical stimulation device for modulating an autonomic nervous system of a user comprising:

a frame;

an electrode configured to deliver an electric stimulus to the skin of the user;

a power source mechanically coupled to the frame and electrically coupled to the

electrode;

a sensor configured to detect an autonomic nervous system metric; and

a controller configured to control at least one of a power and a duration of the electric stimulus based on the autonomic nervous system metric.

2. The electrical stimulation device of claim 1, wherein the frame is configured to be worn across a human user's forehead and behind the human's ears.

3. The electrical stimulation device of claim 1 or 2, wherein the frame further comprises an eye mask coupled to the frame.

4. The electrical stimulation device of claim 3, wherein the eye mask is removably coupled to the frame via a coupler.

5. The electrical stimulation device of claim 4, wherein the coupler comprises a magnet.

6. The electrical stimulation device of claim 3, wherein at least one of the frame and the eye mask comprises a light-emitting diode (LED).

7. The electrical stimulation device of any of the preceding claims, wherein the sensor comprises an electroencephalogram (EEG) electrode, and the autonomic nervous system metric comprises an EEG of the user's brain activity.

8. The electrical stimulation device of any one of claims 1-6, wherein the sensor comprises a temperature sensor, and the autonomic nervous system metric comprises a temperature of the user.

9. The electrical stimulation device of any one of claims 1-6, wherein the sensor comprises a skin conductivity electrode, and the autonomic nervous system metric comprises a conductance of the user's skin.

10. The electrical stimulation device of any one of claims 1-6, wherein the sensor comprises a pulse sensor, and the autonomic nervous system metric comprises a heart rate of the user.

11. The electrical stimulation device of claim 9, wherein the pulse sensor comprises a blood volume pulse sensor.

12. The electrical stimulation device of any one of claims 1-6, wherein the sensor comprises a Laser Doppler Velocimeter (LDV), and the autonomic nervous system metric comprises at least one of a blood flow rate, a blood volume amplitude, and a pulse transit time of the user.

13. The electrical stimulation device of any one of claims 1-6, wherein the sensor comprises an electrocardiogram (ECG) electrode, and the autonomic nervous system metric comprises an electrocardiogram.

14. The electrical stimulation device of any one of claims 1-6, wherein the sensor comprises a respiration rate sensor, and the autonomic nervous system metric comprises a respiration rate.

15. A system for modulating the autonomic nervous system comprising:

an electrical stimulation device according to any one of claims 1-14; and

an audio system configured to entrain the user's brain waves with a binaural beat.

16. A method of modulating the autonomic nervous system comprising:

providing an electrical stimulation device according to any one of claims 1-14; and providing software that when installed on a phone or tablet of the user is configured to play binaural audio that entrains the user's brain waves.

17. The method of claim 16, further comprising providing an anxiolytic agent to the user.

18. The method of claim 17, wherein the anxiolytic agent comprises a topical anxiolytic agent.

19. The method of claim 18, wherein the topical anxiolytic agent comprises a bio-frequency chip.

20. The method of claim 16, wherein the anxiolytic agent comprises an oral anxiolytic agent.

21. A system for balancing and maintaining the health of the human autonomic nervous system, the system comprising:

a wearable frame;

cranio-electrical stimulation (CES) circuitry and electrodes positioned on the wearable frame;

audio entrainment with binaural beats circuitry and audio outputs; and

a visual mask attachable to the wearable frame, the visual mask comprising light- blocking material and frequency-following response visual stimulation circuitry and lights.