Diagnosis, treatment, and research of brain disorders

• US 7,610,095 B2
• Filed: 05/10/2006
• Issued: 10/27/2009
• Est. Priority Date: 04/27/2001
• Status: Expired due to Fees

• Current Assignee: Biophysical Mind Technologies Limited
• Original Assignee: Biophysical Mind Technologies Limited
• Inventors: Naisberg, Yakov
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US11/431,729
• Publication Number:
  US 20060259094A1
• Time in Patent Office: 1,266 Days
• Field of Search: 607 1- 2, 607/45, 607/115, 607/139, 600544-545
• US Class Current: 607/45
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition

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

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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. The CES according to claim 7, wherein:

the injection delay is selected as 40 msec.

9. 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.

10. The CES according to claim 9, wherein:

the specific delay is selected as 5 msec.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. The CES according to claim 1, wherein:

the array of electrodes has n electrodes, and n(n−

1);

2 combinations of pairs of electrodes.

17. 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 μ

A and from 1 to 3 mA for a signal duration lasting from 2 to 500 msec.

18. The CES according to claim 1, wherein:

the diagnosis mode is run in less than 15 seconds.

19. The CES according to claim 1, wherein:

treatment time lasts for less than 1.5 minutes.

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.

21. 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.

22. 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.

23. 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.

24. The CES according to claim 23, wherein:

the specific delay is selected as 5 msec.

25. 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.

26. 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.

27. 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.

28. 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.

29. The CES according to claim 28, wherein:

the injection delay is selected as 40 msec.

30. 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.

31. 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.

32. 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.

33. 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.

34. 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.

35. The CES according to claim 20, wherein:

the array of electrodes has n electrodes, and n(n−

1);

2 combinations of pairs of electrodes.

36. 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 μ

A for a signal duration lasting from 2 to 500 msec.

37. The CES according to claim 20, wherein:

the diagnosis mode is run in less than 15 seconds.

38. The CES according to claim 20, wherein:

treatment time lasts for less than 1.5 minutes.

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.