# US 7,610,095 B2 · Diagnosis, treatment, and research of brain disorders

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- Number: US 7,610,095 B2
- Document ID: US7610095B2
- Status: Granted
- Kind: B2
- Application number: 11/431,729
- Filed: 2006-05-10
- Published: 2006-11-16
- Granted: 2009-10-27
- Earliest claimed: 2001-04-27
- Assignees: Biophysical Mind Technologies, Ltd.
- Inventors: Yakov Naisberg
- Web page: https://patentgrep.com/patent/US7610095B2

## CPC

- A61B 5/053: Measuring electrical impedance or conductance of a portion of the body
- A61B 5/4094: {Diagnosing or monitoring seizure diseases, e.g. epilepsy}
- A61B 5/6814: {Head}
- A61N 1/36025: {for treating a mental or cerebral condition}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)

## Abstract

A method and a Cranial Electrical Stimulator CES for operation in a diagnosis, treatment, research, and test mode related to brain disorders, namely to mental disorders, and to neurological disorders, such as migraine and epilepsy, are disclosed. Diagnosis is based on a detected condition of passage of an electric signal via a pathway in the brain defined as passing from a first to a second electrode of a pair of electrodes from an array attached to the skull of a patient. Treatment is achieved by injecting a treatment signal in the pathway detected as having a condition. A practitioner operates a workstation of the CES that controls a signal and routing box SRB generating input signals and receiving output signal from the brain, via the skull and electrodes. The PC of the workstation controls signal input, output reception, measurement, display and storage in memory.

## Claims

### Claim 1

A Cranial Electric Stimulator (CES), having a computer (PC) running a computer program for operating a diagnosis mode, a treatment mode, a research mode and a test mode and comprising an array of designated electrodes adapted to be attached in distribution onto a skull of a patient, the CES comprising:
a workstation operated by a practitioner and coupled to a signal and routing box (SRB), to which the array of electrodes is coupled, the workstation being programmed to command the SRB to
in the diagnosis mode:
generation of predetermined alternating current diagnosis input signals injection via a first pair of electrodes,
sampling and measurement of induced voltage signals collected across the first pair of electrodes, and
injection and measurement being repeated sequentially for all combinations of pairs of electrodes out of the array of electrodes, wherein each one of the pairs of electrodes defines a path in the brain of the patient, for detection of a signal passage condition along a defined path, and in the treatment mode:
generation of predetermined alternating current treatment input signals injected for relief of a condition detected in the diagnosis mode.

### Claim 2 (depends on 1)

The CES according to claim 1, wherein:
the treatment mode is operated for adaptive selection of the injected treatment signals according to the detection achieved in the diagnosis mode.

### Claim 3 (depends on 1)

The CES according to claim 1, wherein:
in the diagnosis mode:
diagnosis induced voltage output signals are retrieved from the array of electrodes, measured and displayed in relation to corresponding designated electrode pairs, for detection of signal passage paths displaying a condition and standard data.

### Claim 4 (depends on 3)

The CES according to claim 3, wherein:
the induced voltage diagnosis output signals are measured in dimensions selected from the group of dimensions consisting of voltage, current, frequency, impedance, resistance and conductance.

### Claim 5 (depends on 3)

The CES according to claim 3, wherein:
the diagnosis induced voltage output signals are processed for display and displayed in association with electrode pair designation, for detection and diagnosis of brain disorder.

### Claim 6 (depends on 1)

The CES according to claim 1, wherein alternating current diagnosis input signals include:
a current amplitude of 0.5 mA, a current frequency of 25 KHz and a current duration of 10 msec.

### Claim 7 (depends on 1)

The CES according to claim 1, wherein:
an injection delay is selected for insertion between the end and the beginning of two successive diagnosis input signals injection.

### Claim 8 (depends on 7)

The CES according to claim 7, wherein:
the injection delay is selected as 40 msec.

### Claim 9 (depends on 1)

The CES according to claim 1, wherein:
diagnosis induced voltage output signals are measured over the pair of electrodes selected for diagnosis signal injection after a specific delay.

### Claim 10 (depends on 9)

The CES according to claim 9, wherein:
the specific delay is selected as 5 msec.

### Claim 11 (depends on 1)

The CES (4) according to claim 1, wherein:
the treatment mode includes injection of a treatment input signal in at least one pair of electrodes chosen in accordance with the detection of a signal passage condition achieved in the diagnosis mode.

### Claim 12 (depends on 1)

The CES according to claim 1, wherein:
treatment input signals are selected as an alternating current signal with predetermined signal current parameters comprising:
a current amplitude selected from the group consisting of current amplitudes spanning the range from 0.5 mA to 2.5 mA,
a current frequency selected as either one of both 50 KHz to 100 KHz, and
a current duration selected from the group consisting of current durations spanning the range from 100 msec to 500 msec.

### Claim 13 (depends on 12)

The CES according to claim 12, wherein:
treatment input signals are selected to include a current amplitude of 1.5 mA, a current frequency of 50 or 100 KHz, and a current duration of 250 msec.

### Claim 14 (depends on 12)

The CES according to claim 12, wherein
an injection delay is selected for insertion between the end and the beginning of two successive treatment injection signals.

### Claim 15 (depends on 12)

The CES according to claim 12, wherein:
the treatment input signal is selected as an alternating current signal with predetermined signal current parameters comprising current amplitude, current frequency and current duration, the treatment input signals being automatically injected sequentially into pairs of electrodes chosen in predetermined sequence from an array of electrodes.

### Claim 16 (depends on 1)

The CES according to claim 1, wherein:
the array of electrodes has n electrodes, and n(n−1):2 combinations of pairs of electrodes.

### Claim 17 (depends on 1)

The CES according for claim 1, wherein:
the SRB generates sinusoidal signals, a discretely selectable current frequency ranging from 10 Hz to 500 Hz and from 10 to 100 KHz, with current-steps spanning from 50 to 500 μA and from 1 to 3 mA for a signal duration lasting from 2 to 500 msec.

### Claim 18 (depends on 1)

The CES according to claim 1, wherein:
the diagnosis mode is run in less than 15 seconds.

### Claim 19 (depends on 1)

The CES according to claim 1, wherein:
treatment time lasts for less than 1.5 minutes.

### Claim 20

A Cranial Electric Stimulator (CES), for facilitating return to brain homeostasis and having a computer (PC) running a computer program for operating a diagnosis mode, a treatment mode, a research mode and a test mode, and comprising an array of designated electrodes adapted to be attached in distribution onto a skull of a patient, the CES comprising:
a workstation operated by a practitioner and coupled to a signal and routing box (SRB), to which the array of electrodes is coupled, the workstation being programmed to command the SRB to:
in the diagnosis mode:
generation of predetermined alternating current diagnosis input signals for injection via a first pair of electrodes,
sampling and measurement of induced voltage signals collected across the first pair of electrodes, and
injection and measurement being repeated sequentially for all the combinations of pairs of electrodes out of the array of electrodes, wherein each one of pair electrodes defines a path in the brain, for detection of a signal passage condition along a defined path;
in the treatment mode:
generation of predetermined alternating current input treatment signals injected for relief of a condition detected in the diagnosis mode; and
in the research mode:
generation of selected alternating current research diagnosis input signals permitting injection into and retrieval of output signals from the brain, and selecting injection of alternating current research treatment input signals.

### Claim 21 (depends on 20)

The CES according to claim 20, wherein:
the treatment mode is operated for adaptive selection of the injected treatment signals according to the detection achieved in the diagnosis mode.

### Claim 22 (depends on 20)

The CES according to claim 20, wherein:
in the diagnosis mode:
diagnosis induced voltage output signals being retrieved from the array of electrodes, measured and displayed in relation to corresponding designated pairs, for detection of signal passage paths displaying a condition.

### Claim 23 (depends on 22)

The CES according to claim 22, wherein:
diagnosis induced voltage output signals are measured over the pair of electrodes selected for diagnosis signal injection after a specific injection delay.

### Claim 24 (depends on 23)

The CES according to claim 23, wherein:
the specific delay is selected as 5 msec.

### Claim 25 (depends on 22)

The CES according to claim 22, wherein:
the diagnosis induced voltage output signals are measured in dimensions selected from the group of dimensions consisting of voltage, current, frequency, impedance, resistance and conductance.

### Claim 26 (depends on 22)

The CES according to claim 22, wherein:
the diagnosis induced voltage output signals are processed for display and displayed in association with electrode pair designation, for detection and diagnosis of brain disorder.

### Claim 27 (depends on 20)

The CES according to claim 20, wherein alternating current diagnosis input signals include:
a current amplitude of 0.5 mA, a current frequency of 25 KHz and a current duration of 10 msec.

### Claim 28 (depends on 20)

The CES according to claim 20, wherein:
an injection delay is selected for insertion between the end and the beginning of two successive diagnosis input signal injections.

### Claim 29 (depends on 28)

The CES according to claim 28, wherein:
the injection delay is selected as 40 msec.

### Claim 30 (depends on 20)

The CES according to claim 20, wherein:
a treatment mode includes injection of a treatment input signal in at least one pair of electrodes chosen in accordance with the detection of a signal passage condition achieved in the diagnosis mode.

### Claim 31 (depends on 30)

The CES according to claim 30, wherein:
treatment input signals are selected as an alternating current signal with predetermined signal current parameters comprising:
current amplitude selected from the group consisting of current amplitudes spanning the range from 0.5 mA to 2.5 mA,
current frequency selected as either one of both 50 KHz to 100 KHz, and
current duration selected from the group consisting of current durations spanning the range from 100 msec to 500 msec.

### Claim 32 (depends on 31)

The CES according to claim 31, wherein:
treatment input signals are selected to include a current amplitude of 1.5 mA, a current frequency of 50 and 100 KHz, and a current duration of 250 msec.

### Claim 33 (depends on 31)

The CES according to claim 31, wherein:
an injection delay is selected for insertion between the end and the beginning of two successive treatment injection signals.

### Claim 34 (depends on 33)

The CES according to claim 33, wherein:
the treatment input signal is selected as an alternating current signal with predetermined signal current parameters comprising current amplitude, current frequency and current duration, the treatment input signals being automatically injected sequentially into pairs of electrodes chosen in predetermined sequence from an array of 24 electrodes.

### Claim 35 (depends on 20)

The CES according to claim 20, wherein:
the array of electrodes has n electrodes, and n(n−1):2 combinations of pairs of electrodes.

### Claim 36 (depends on 20)

The CES according to claim 20, wherein:
the SRB generates sinusoidal signals, a discretely selectable current frequency ranging from 10 Hz to 500 Hz and from 10 to 100 KHz, with current-steps spanning from 50 to 500 microA and from 1 to 3 μA for a signal duration lasting from 2 to 500 msec.

### Claim 37 (depends on 20)

The CES according to claim 20, wherein:
the diagnosis mode is run in less than 15 seconds.

### Claim 38 (depends on 20)

The CES according to claim 20, wherein:
treatment time lasts for less than 1.5 minutes.

### Claim 39

A Cranial Electric Stimulator (CES), facilitating return to brain homeostasis after a migraine and having a computer (PC) running a computer program for operating a diagnosis mode, a treatment mode, a research mode and a test mode and comprising an array of designated electrodes adapted to be attached in a distribution onto a skull of a patient, the CES comprising:
a workstation operated by a practitioner and coupled to a signal and routing box (SRB), to which the array of electrodes is coupled, the workstation being programmed to command the SRB to:
in the diagnosis mode:
generation of predetermined alternating current diagnosis input signals for injection via a first pair of electrodes,
sampling and measurement of induced voltage signals collected across the first pair of electrodes, and
injection and measurement being repeated sequentially for all the combinations of pairs of electrodes out of the array of electrodes, wherein each one of the pairs of electrodes defines a path in the brain, for detection of a signal passage condition along a defined path;
in the treatment mode:
generation of predetermined alternating current input treatment signals injected for relief of a condition detected in the diagnosis mode; and
in the research mode:
selected alternating current research diagnosis input signals permitting injection into and retrieval of output signals from the brain, and selecting injection of alternating current research treatment input signals.