# US 8,280,502 B2 · Method and apparatus for utilizing amplitude-modulated pulse-width modulation signals for neurostimulation and treatment of neurological disorders using electrical stimulation

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- Number: US 8,280,502 B2
- Document ID: US8280502B2
- Status: Granted
- Kind: B2
- Application number: 12/765,561
- Filed: 2010-04-22
- Published: 2010-08-12
- Granted: 2012-10-02
- Earliest claimed: 2002-02-04
- Assignees: Cerephex Corporation
- Inventors: Jeffrey B. Hargrove; Theodore J. Stokes; Mary L. Esty
- Web page: https://patentgrep.com/patent/US8280502B2

## CPC

- A61N 1/36025: {for treating a mental or cerebral condition}
- A61B 5/374: Detecting the frequency distribution of signals, e.g. detecting delta, theta, alpha, beta or gamma waves
- A61B 5/4076: {Diagnosing or monitoring particular conditions of the nervous system}
- A61N 1/36021: {for treatment of pain}
- 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)

## Abstract

A computing device-controlled system is described for the generation of amplitude-modulated pulse-width modulation (AMPWM) signals for use in treating neurological dysfunction via cranial neurostimulation, where the AMPWM signal is specifically designed to minimize the electrical impedance of the tissues of the head. A low-frequency carrier signal is determined for the AMPWM signal by measuring EEG activity at a reference site or sites, generally corresponding with the location of suspected brain dysfunction. Carrier signal frequency is variably related to critical frequency components of the EEG power spectral density, determined from statistical analysis of amplitudes and variability, and dynamically changed as a function of time to prevent entrainment. The AMPWM signal is presented to a subject via a plurality of neurostimulation delivery modes for therapeutic use.

## Claims

### Claim 1

A system for providing external electrical stimulation and treatment for a disorder by electrically stimulating and treating neurological tissue of a region of a brain, the system comprising:
means for generating an amplitude-modulated pulse-width modulation (AMPWM) signal, the AMPWM signal including a high frequency signal component and a low frequency signal component, wherein the high frequency signal component is amplitude-modulated and pulse-width modulated, wherein the high frequency signal component has a sufficiently high frequency to enable the AMPWM signal to penetrate high impedance portions of tissue located between external EEG sensors placed on a scalp and the neurological tissue of the region of the brain being stimulated, wherein the low frequency signal component is of sufficiently low frequency to provide the electrical stimulation and treatment, and wherein the low frequency signal component dynamically varies in frequency over time; and
means for transmitting the AMPWM signal from a neurostimulation device to the neurological tissue of the region of the brain being stimulated via the external EEG sensors placed on the scalp.

### Claim 2 (depends on 1)

The system of claim 1, wherein the neurostimulation device and EEG sensors are externally located relative to the tissue and the neurological tissue of the region of the brain.

### Claim 3 (depends on 1)

The system of claim 1, wherein the disorder to be treated is a neurological disorder.

### Claim 4 (depends on 1)

The system of claim 1, further comprising means for simultaneously providing electrical stimulation and measuring of an overlapping voltage.

### Claim 5 (depends on 4)

The system of claim 4, wherein the overlapping voltage is an electroencephalogram (EEG) signal.

### Claim 6

A system for providing external electrical stimulation and treatment for a disorder by electrically stimulating and treating neurological tissue of a region of a brain, the system comprising:
a signal generator for generating an amplitude-modulated pulse-width modulation (AMPWM) signal, the generated AMPWM signal including a high frequency signal component and a low frequency signal component, wherein the high frequency signal component is amplitude-modulated and pulse-width modulated, wherein the high frequency signal component has a sufficiently high frequency to enable the generated AMPWM signal to penetrate high impedance portions of tissue located between external EEG sensors placed on a scalp and the neurological tissue of the region of the brain being stimulated, wherein the low frequency signal component is of sufficiently low frequency to provide the electrical stimulation and treatment; and
a transmission device coupled to the signal generator, wherein the transmission device transmits an electrical stimulation and treatment signal from the generated AMPWM signal, and wherein the transmitted electrical stimulation and treatment signal is communicated from the neurostimulation device to the neurological tissue of the region of the brain being stimulated via the external EEG sensors placed on the scalp to electrically stimulate and treat the disorder.

### Claim 7 (depends on 6)

The system of claim 6, wherein the neurostimulation device and EEG sensors are externally located relative to the tissue and the neurological tissue of the region of the brain to be treated.

### Claim 8 (depends on 6)

The system of claim 6, wherein the low frequency signal component dynamically varies in frequency over time.

### Claim 9 (depends on 6)

The system of claim 6, wherein the disorder to be treated is a neurological disorder.

### Claim 10 (depends on 6)

The system of claim 6, wherein the electrical stimulation and treatment signal includes an external stimulation signal that drives an external stimulation device.

### Claim 11 (depends on 10)

The system of claim 10, wherein the external stimulation device is an audio stimulation device.

### Claim 12 (depends on 10)

The system of claim 10, wherein the external stimulation device is an optic stimulation device.

### Claim 13 (depends on 10)

The system of claim 10, further comprising:
a processor coupled to the signal generator, the processor being capable of controlling the signal generator.

### Claim 14 (depends on 13)

The system of claim 13, further comprising:
a sensor coupled to the processor, the sensor being capable of receiving information from at least one reference site of the tissue located between the neurostimulation device and the neurological tissue of the region of the brain being stimulated, wherein information from the sensor is a parameter in determining the AMPWM signal.

### Claim 15 (depends on 14)

The system of claim 14, wherein the sensor coupled to the processor is a lead for the neurostimulation device that transmits the electrical stimulation.

### Claim 16 (depends on 15)

The system of claim 15, wherein the sensor coupled to the processor and the lead for the transmission is the electroencephalogram (EEG) sensor.

### Claim 17 (depends on 15)

The system of claim 15, wherein the system is capable of simultaneous electrical stimulation and receipt of information from the at least one reference site of the tissue located between the neurostimulation device and the neurological tissue of the region of the brain.

### Claim 18 (depends on 14)

The system of claim 14, wherein the sensor is capable of receiving electroencephalogram (EEG) information.

### Claim 19 (depends on 1)

The system of claim 1, wherein the high frequency signal component is in the range of 43 hertz to 1,000,000 hertz and the low frequency signal component is in the range of 1 hertz -43 hertz.

### Claim 20 (depends on 19)

The system of claim 19, wherein the high frequency signal component is in the range of 1,000 hertz -100,000 hertz.

### Claim 21 (depends on 19)

The system of claim 19, wherein the high frequency signal component is in the range of 10,000 hertz -20,000 hertz.

### Claim 22 (depends on 6)

The system of claim 6, wherein the high frequency signal component is amplitude-modulated and pulse-width modulated so as to control a time-averaged current of the AMPWM signal when passing through a conducting medium, wherein the conducting medium comprises the tissue located between the external EEG sensors placed on the scalp and the neurological tissue of the region of the brain being stimulated.
