# US 10,307,611 B2 · Methods and systems for neural stimulation via visual, auditory and peripheral nerve stimulations

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- Number: US 10,307,611 B2
- Document ID: US10307611B2
- Status: Granted
- Kind: B2
- Application number: 15/816,238
- Filed: 2017-11-17
- Published: 2018-05-17
- Granted: 2019-06-04
- Earliest claimed: 2016-11-17
- Assignees: Cognito Therapeutics, Inc.
- Applicants: Cognito Therapeutics, Inc.
- Inventors: Zachary John Hambrecht Malchano; Martin Warren Williams
- Web page: https://patentgrep.com/patent/US10307611B2

## CPC

- A61N 5/0622: {Optical stimulation for exciting neural tissue}
- A61B 5/0036: {including treatment, e.g., using an implantable medical device, ablating, ventilating}
- A61B 5/16: Devices for psychotechnics (using teaching or educational appliances G09B1/00 - G09B7/00); Testing reaction times {; Devices for evaluating the psychological state}
- A61B 5/377: using evoked responses
- A61B 5/378: Visual stimuli
- A61B 5/38: Acoustic or auditory stimuli
- A61B 5/4088: {Diagnosing of monitoring cognitive diseases, e.g. Alzheimer, prion diseases or dementia}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61M 21/00: Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/36025: {for treating a mental or cerebral condition}
- A61N 1/36036: {of the outer, middle or inner ear}
- A61N 1/36082: {Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease}
- A61N 1/36092: {Mental training}
- A61N 1/36132: {using patient feedback}
- A61N 5/0618: {Psychological treatment}
- G02C 11/10: {Electronic devices other than hearing aids}
- G16H 20/70: relating to mental therapies, e.g. psychological therapy or autogenous training
- G16H 40/63: for local operation
- G16H 40/67: for remote operation
- H05B 47/105: in response to determined parameters
- A61B 3/113: for determining or recording eye movement
- A61B 5/024: Measuring pulse rate or heart rate
- A61B 5/05: Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves (measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24)
- A61B 5/163: {by tracking eye movement, gaze, or pupil change}
- A61B 5/168: {Evaluating attention deficit, hyperactivity}
- A61B 5/375: using biofeedback
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 5/6803: {Head-worn items, e.g. helmets, masks, headphones or goggles}
- A61M 2021/0027: {by the hearing sense}
- A61M 2021/0044: {by the sight sense}
- A61M 2021/0072: {with application of electrical currents}
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 2005/0626: {Monitoring, verifying, controlling systems and methods}
- A61N 2005/0627: {Dose monitoring systems and methods}
- A61N 2005/0629: {Sequential activation of light sources}
- A61N 2005/0648: {the light being directed to the eyes}
- A61N 2005/0652: {Arrays of diodes}
- A61N 2005/0659: {infrared}
- A61N 2005/0661: {ultraviolet}
- A61N 2005/0662: {Visible light}
- A61N 2005/0663: {Coloured light}
- A61N 2005/0667: {Filters}
- G02C 2200/10: Frame or frame portions made from wire
- G16H 10/20: for electronic clinical trials or questionnaires
- G16H 10/60: for patient-specific data, e.g. for electronic patient records
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H 70/20: relating to practices or guidelines
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- G02C: SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES (trial frames for testing the eyes A61B3/04; goggles or eyeshields not having the same features as spectacles A61F9/00)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- H05B: ELECTRIC HEATING; ELECTRIC LIGHT SOURCES NOT OTHERWISE PROVIDED FOR; CIRCUIT ARRANGEMENTS FOR ELECTRIC LIGHT SOURCES, IN GENERAL

## Abstract

Systems and methods of the present disclosure are directed to systems and methods for treating cognitive dysfunction in a subject in need thereof. The system can include a light source and a speaker. A visual neural stimulation system provides, via the light source, visual stimulation having a first value of a first parameter. An auditory neural stimulation system provides, via the speaker, audio stimulation having a second value of the second parameter. A stimuli orchestration component selects, for a first time interval, one of the visual stimulation or the audio stimulation to vary based on a policy, selects, for the first time interval, the other of the visual stimulation or the audio stimulation to keep constant based on the policy, and provides causes the one of the visual neural stimulation system or the auditory neural stimulation system to vary the one of the visual stimulation or the audio stimulation.

## Claims

### Claim 1

A system for treating cognitive dysfunction in a subject in need thereof, comprising:
a light source;
a speaker;
a visual signaling component executed by a visual neural stimulation system and configured to provide, via the light source, visual stimulation having a first value of a first parameter;
an audio signaling component executed by an auditory neural stimulation system configured to provide, via the speaker, audio stimulation having a second value of the second parameter; and
a stimuli orchestration component executed by a neural stimulation orchestration system and configured to:
receive an indication of an ambient condition and an indication of a physiological condition of the subject;
select, for a first time interval, an offset between the visual stimulation and the audio stimulation to vary based on a policy and the indication of the ambient condition and the indication of the physiological condition of the subject, and
provide instructions to at least one of the visual neural stimulation system or the auditory neural stimulation system corresponding to the selected offset between the visual stimulation and the audio stimulation to vary to cause the at least one of the visual neural stimulation system or the auditory neural stimulation system to vary the offset between the visual stimulation and the audio stimulation.

### Claim 2 (depends on 1)

The system of claim 1, wherein the neural stimulation orchestration system is further configured to:
select, for a second time interval subsequent to the first time interval, one of the visual stimulation or the audio stimulation to vary based on the policy;
select, for the second time interval, the other of the visual stimulation or the audio stimulation to keep constant based on the policy; and
provide instructions to the visual neural stimulation system or the auditory neural stimulation system corresponding to the selected one of the visual stimulation or the audio stimulation to vary during the second time interval to cause the one of the visual neural stimulation system or the auditory neural stimulation system to vary the one of the visual stimulation or the audio stimulation during the second time interval.

### Claim 3 (depends on 1)

The system of claim 1, comprising:
a feedback monitor configured to detect the physiological condition of the subject during the first time interval,
wherein the neural stimulation orchestration system is further configured to select, using the policy and based on the detected physiological condition, one of the visual stimulation or the audio stimulation to vary during the first time interval.

### Claim 4 (depends on 1)

The system of claim 1, comprising:
a microphone configured to detect an ambient sound level; and
a photodiode configured to detect an ambient light level,
wherein the neural stimulation orchestration system is further configured to select, based on the ambient sound level and the ambient light level, one of the visual stimulation or the audio stimulation to vary during the first time interval.

### Claim 5 (depends on 1)

The system of claim 1, comprising:
an electrode to provide peripheral nerve stimulation to the subject, wherein
wherein the neural stimulation orchestration system is further configured to select, based on the policy, one of the visual stimulation, the audio stimulation, or the peripheral nerve stimulation to vary during a second time interval.

### Claim 6 (depends on 1)

The system of claim 1, wherein the visual stimulation is selected for varying during the first time interval, the system comprising:
an electrode to provide peripheral nerve stimulation to the subject during the first time interval; and
a feedback monitor configured to detect the physiological condition of the subject during the first time interval,
wherein the neural stimulation orchestration system is further configured to:
select, responsive to detecting the physiological condition, one of the audio stimulation or the peripheral nerve stimulation to vary during a second time interval subsequent to the first time interval;
select, for the second time interval, the visual stimulation to keep constant;
provide instructions to the visual neural stimulation system to keep constant during the second time interval;
provide instructions to the auditory neural stimulation system to vary during the second time interval; and
provide instructions to the electrode to keep constant during the second time interval.

### Claim 7 (depends on 1)

The system of claim 1, wherein the cognitive dysfunction comprises Alzheimer's disease.

### Claim 8 (depends on 1)

The system of claim 1, comprising:
a feedback monitor configured to detect the physiological condition of the subject during the first time interval,
wherein the neural stimulation orchestration system is further configured to:
select, responsive to detecting the physiological condition, the of the visual stimulation or the audio stimulation to vary during a second time interval subsequent to the first time interval;
select, for the second time interval, the other of the visual stimulation or the audio stimulation to keep constant; and
provide instructions to the visual neural stimulation system or the auditory neural stimulation system corresponding to the selected one of the visual stimulation or the audio stimulation to vary during the second time interval to cause the one of the visual neural stimulation system or the auditory neural stimulation system to vary the one of the visual stimulation or the audio stimulation during the second time interval.

### Claim 9

A system for treating cognitive dysfunction in a subject in need thereof, comprising:
a visual neural stimulation system configured to provide, via a light output source, visual stimulation having a first value of a first parameter;
an auditory neural stimulation system configured to provide, via an audio output source, audio stimulation having a second value of the second parameter; and
a neural stimulation orchestration system configured to:
receive an indication of an ambient condition and an indication of a physiological condition of the subject;
select, for a first time interval, an offset between the visual stimulation and the audio stimulation to vary based on a policy and the indication of the ambient condition and the indication of the physiological condition of the subject, and
provide instructions to at least one of the visual neural stimulation system or the auditory neural stimulation system corresponding to the selected offset between the visual stimulation and the audio stimulation to vary to cause the at least one of the visual neural stimulation system or the auditory neural stimulation system to vary the offset between the visual stimulation and the audio stimulation.

### Claim 10 (depends on 9)

The system of claim 9, wherein the neural stimulation orchestration system is further configured to:
select, for a second time interval subsequent to the first time interval, one of the visual stimulation or the audio stimulation to vary based on the policy;
select, for the second time interval, the other of the visual stimulation or the audio stimulation to keep constant based on the policy; and
provide instructions to the visual neural stimulation system or the auditory neural stimulation system corresponding to the selected one of the visual stimulation or the audio stimulation to vary during the second time interval to cause the one of the visual neural stimulation system or the auditory neural stimulation system to vary the one of the visual stimulation or the audio stimulation during the second time interval.

### Claim 11 (depends on 9)

The system of claim 9, comprising:
a feedback monitor configured to detect the physiological condition of the subject during the first time interval,
wherein the neural stimulation orchestration system is further configured to select, using the policy and based on the detected physiological condition, one of the visual stimulation or the audio stimulation to vary during the first time interval.

### Claim 12 (depends on 9)

The system of claim 9, comprising:
a feedback monitor configured to detect the physiological condition of the subject during the first time interval,
wherein the neural stimulation orchestration system is further configured to:
select, responsive to detecting the physiological condition, one of the visual stimulation or the audio stimulation to vary during a second time interval subsequent to the first time interval;
select, for the second time interval, the other of the visual stimulation or the audio stimulation to keep constant; and
provide instructions to the visual neural stimulation system or the auditory neural stimulation system corresponding to the selected one of the visual stimulation or the audio stimulation to vary during the second time interval to cause the one of the visual neural stimulation system or the auditory neural stimulation system to vary the one of the visual stimulation or the audio stimulation during the second time interval.

### Claim 13 (depends on 9)

The system of claim 9, comprising:
a microphone configured to detect an ambient sound level; and
a photodiode configured to detect an ambient light level,
wherein the neural stimulation orchestration system is further configured to select, based on the ambient sound level and the ambient light level, one of the visual stimulation or the audio stimulation to vary during the first time interval.

### Claim 14 (depends on 9)

The system of claim 9, comprising:
an electrode to provide peripheral nerve stimulation to the subject,
wherein the neural stimulation orchestration system is further configured to select, based on the policy, one of the visual stimulation, the audio stimulation, or the peripheral nerve stimulation to vary during a second time interval.

### Claim 15 (depends on 9)

The system of claim 9, wherein the visual stimulation is selected for varying during the first time interval, the system comprising:
an electrode to provide peripheral nerve stimulation to the subject during the first time interval; and
a feedback monitor configured to detect the physiological condition of the subject during the first time interval,
wherein the neural stimulation orchestration system is further configured to:
select, responsive to detecting the physiological condition, one of the audio stimulation or the peripheral nerve stimulation to vary during a second time interval subsequent to the first time interval;
select, for the second time interval, the visual stimulation to keep constant;
provide instructions to the visual neural stimulation system to keep constant during the second time interval;
provide instructions to the auditory neural stimulation system to vary during the second time interval; and
provide instructions to the electrode to keep constant during the second time interval.

### Claim 16 (depends on 9)

The system of claim 9, wherein the cognitive dysfunction comprises Alzheimer's disease.

### Claim 17

A system for treating cognitive dysfunction in a subject in need thereof, comprising:
a visual neural stimulation system;
an auditory neural stimulation system;
a neural stimulation orchestration system;
a light output source;
an audio output source; and
one or more processors configured to execute one or more programs to treat a subject in need of a treatment of a brain disease, the one or more programs including instructions for conducting a therapy session, the therapy session comprising:
providing, via the light output source, visual stimulation having a first value of a first parameter;
providing, via the audio output source, audio stimulation having a second value of the second parameter;
receiving an indication of an ambient condition and an indication of a physiological condition of the subject;
selecting, for a first time interval, an offset between the visual stimulation and the audio stimulation to vary based on a policy and the indication of the ambient condition and the indication of the physiological condition of the subject, and
providing instructions to at least one of the visual neural stimulation system or the auditory neural stimulation system corresponding to the selected offset between the visual stimulation and the audio stimulation to vary to cause the at least one of the visual neural stimulation system or the auditory neural stimulation system to vary the offset between the visual stimulation and the audio stimulation.

### Claim 18 (depends on 17)

The system of claim 17, wherein the therapy session comprises:
selecting, for a second time interval subsequent to the first time interval, the other of the visual stimulation or the audio stimulation to vary based on the policy;
selecting, for the second time interval, the other of the visual stimulation or the audio stimulation to keep constant based on the policy; and
providing instructions to the visual neural stimulation system or the auditory neural stimulation system corresponding to the selected one of the visual stimulation or the audio stimulation to vary during the second time interval to cause the one of the visual neural stimulation system or the auditory neural stimulation system to vary the one of the visual stimulation or the audio stimulation during the second time interval.

### Claim 19 (depends on 17)

The system of claim 17, wherein the therapy session comprises:
detecting the physiological condition of the subject during the first time interval,
selecting, using the policy and based on the detected physiological condition, one of the visual stimulation or the audio stimulation to vary during the first time interval.

### Claim 20 (depends on 17)

The system of claim 17, wherein the therapy session comprises:
detecting the physiological condition of the subject during the first time interval;
selecting, responsive to detecting the physiological condition, the other of the visual stimulation or the audio stimulation to vary during a second time interval subsequent to the first time interval;
selecting, for the second time interval, the other of the visual stimulation or the audio stimulation to keep constant; and
providing instructions to the visual neural stimulation system or the auditory neural stimulation system corresponding to the selected one of the visual stimulation or the audio stimulation to vary during the second time interval to cause the one of the visual neural stimulation system or the auditory neural stimulation system to vary the one of the visual stimulation or the audio stimulation during the second time interval.

### Claim 21 (depends on 17)

The system of claim 17, wherein the therapy session comprises:
detecting an ambient sound level;
detecting an ambient light level; and
selecting, based on the ambient sound level and the ambient light level, one of the visual stimulation or the audio stimulation to vary during the first time interval.

### Claim 22 (depends on 17)

The system of claim 17, wherein the therapy session comprises:
providing, via an electrode, peripheral nerve stimulation to the subject; and
selecting, based on the policy, one of the visual stimulation, the audio stimulation, or the peripheral nerve stimulation to vary during a second time interval.

### Claim 23 (depends on 17)

The system of claim 17, wherein the visual stimulation is selected for varying during the first time interval, the therapy session further comprising:
providing, via an electrode, peripheral nerve stimulation to the subject during the first time interval;
detecting the physiological condition of the subject during the first time interval;
selecting, responsive to detecting the physiological condition, one of the audio stimulation or the peripheral nerve stimulation to vary during a second time interval subsequent to the first time interval;
selecting, for the second time interval, the visual stimulation to keep constant;
providing instructions to the visual neural stimulation system to keep constant during the second time interval;
providing instructions to the auditory neural stimulation system to vary during the second time interval; and
providing instructions to the electrode to keep constant during the second time interval.

### Claim 24 (depends on 17)

The system of claim 17, wherein the cognitive dysfunction comprises Alzheimer's disease.

### Claim 25

A method for treating cognitive dysfunction in a subject in need thereof, comprising administering a stimulus to the subject using a system comprising:
a light source;
a speaker;
a visual signaling component executed by a visual neural stimulation system and configured to provide, via the light source, visual stimulation having a first value of a first parameter;
an audio signaling component executed by an auditory neural stimulation system configured to provide, via the speaker, audio stimulation having a second value of the second parameter; and
a stimuli orchestration component executed by a neural stimulation orchestration system and configured to:
receive an indication of an ambient condition and an indication a physiological condition of the subject;
select, for a first time interval, an offset between the visual stimulation and the audio stimulation to vary based on a policy and the indication of the ambient condition and the indication of the physiological condition of the subject, and
provide instructions to at least one of the visual neural stimulation system or the auditory neural stimulation system corresponding to the selected offset between the visual stimulation and the audio stimulation to vary to cause the at least one of the visual neural stimulation system or the auditory neural stimulation system to vary the offset between the visual stimulation and the audio stimulation.

### Claim 26 (depends on 25)

The method of claim 25, wherein the cognitive dysfunction comprises Alzheimer's disease.