Diagnosis, treatment and research of mental disorder

• US 20040138720A1
• Filed: 10/24/2003
• Published: 07/15/2004
• Est. Priority Date: 04/27/2001
• Status: Active Grant

• Current Assignee: Biophysical Mind Technologies Limited
• Original Assignee: Biophysical Mind Technologies Limited
• Inventors: Grinsphoon, Alexander, Naisberg, Yacov, Weizman, Avraham
• Granted Patent: US 7,239,919 B2
• Time in Patent Office: Days
• 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 (4) for operation in a diagnosis, treatment, research, and test mode related to mental disorder, 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 (12) attached to the skull (6) of a patient. Treatment is achieved by injecting a treatment signal in the pathway detected as having a condition.

A practitioner (2) operates a workstation (8) of the CES (4) that controls a signal and routing box SRB (10) generating input signals and receiving output signal from the brain, via the skull (6) and electrodes (12). The PC (14) of the workstation controls signal input, output reception, measurement, display and storage in memory (15).

Claims

1. A method for diagnosing mental disorder by injecting electric input signals into and measuring electric output signals from the brain via electrodes (12) arranged in an array comprising a symmetrical electrodes distribution attached to the skull (6) of a patient, the method being characterized by comprising the steps of:

operating a diagnostic mode comprising automatic sequential injection of diagnosis input signals in predetermined sequence into combinations of pairs of electrodes chosen from the array of electrodes,

measuring output signals from each combination of pairs of electrodes, and

displaying the measured signals for detection and diagnosis of mental disorder.

2. The method according to claim 1, further characterized by comprising the steps of:

identifying electrodes out of the array of electrodes (12) by designations comprising a row designation, a column designation, an electrode pair designation, an electrode designation and an opposite electrode designation.

3. The method according to claim 2, wherein

the array of electrodes (12) comprises at least 4 electrodes and at most 60 electrodes.

4. The method according to claim 2, wherein

the array of electrodes (12) comprises 24 electrodes.

5. The method according to claim 1, further characterized by comprising the step of:

selecting the diagnosis input signal as an alternative current signal with predetermined signal current parameters comprising current amplitude, current frequency and current duration, and

measuring output signals from each combination of pairs of electrodes (12) and from each opposite electrodes pair.

6. The method according to claim 5, further characterized by comprising the step of:

selecting the current amplitude of the diagnosis input signal from the group consisting of current amplitudes spanning the range from 0.1 mA to 5 mA.

7. The method according to claim 5, further characterized by comprising the step of:

selecting the current frequency of the diagnosis input signal from the group consisting of current frequencies spanning the range from 2.5 KHz to 250 KHz.

8. The method according to claim 5, further characterized by comprising the step of:

selecting the current duration of the diagnosis input signal from the group consisting qf current durations spanning the range from 1 msec to 500 msec.

9. The method according to claim 5, further characterized by comprising the step of:

selecting the diagnosis input signal to comprise a current amplitude of 0.5 mA, a current frequency of 25 KHz and a current duration of 10 msec.

10. The method according to the claims 5 or 9, further characterized by comprising the step of:

selecting an injection delay for insertion between the end and the beginning of two successive diagnosis injection signals as an injection delay selected from the group of delays consisting of a range spanning from 4 msec to 400 msec.

11. The method according to claim 12, wherein

the diagnosis injection delay duration is selected as 40 msec.

12. The method according to claim 5, further characterized by comprising the step of:

measuring an output signal over the pair of electrodes selected for signal injection within a specific injection delay after starting but before ending of the signal injection.

13. The method according to claim 12, further characterized by comprising the step of:

selecting the injection delay as 5 msec.

14. The method according to claim 5, further characterized by comprising the step of:

measuring an output signal over the pair of electrodes opposite to the pair of electrodes (12) injected with the diagnosis signal injection within a specific opposite delay after starting but before ending of the signal injection.

15. The method according to claim 14, further characterized by comprising the step of:

selecting the opposite delay as 7 msec.

16. The method according to claim 1, wherein automatically sequentially injecting a diagnosis input signal in pairs of electrodes (12) is further characterized by comprising the steps of:

selecting a first pair of electrodes for injecting therein the diagnosis input signal, and

selecting a next electrode-pair for injecting therein the injection signal, and successively injecting the injection signal in all possible the combinations of electrode-pairs possible out of the array of electrodes.

17. The method according to the claims 5 or 16, further characterized by comprising the steps of:

measuring diagnosis output signals in dimensions selected from the group of dimensions consisting of voltage, frequency, impedance, resistance and conductance.

18. The method according to any of the claims 1, 5, 16, or 17, further characterized by comprising the steps of:

processing the diagnosis output signals for display, and

displaying the diagnosis output signals in association with electrode pair designation for detection and diagnosis of mental disorder.

19. The method according to any of the preceding claims, wherein

multiplication of the current amplitude of the diagnosis input signals injected over an array of 24 electrodes (12) into the skull (6) of a patient by the duration of the current injection, results in a product smaller than 0.015.

20. The method according to claim 1 further characterized by comprising the steps of:

operating a treatment mode comprising injecting a treatment input signal in at least one pair of electrodes (12) chosen in accordance with the detection and diagnosis achieved in the diagnosis mode.

21. The method according to claim 20 further characterized by comprising the steps of:

selecting the treatment input signal as an alternative current signal with predetermined signal current parameters comprising current amplitude, current frequency and current duration.

22. The method according to claim 21, further characterized by comprising the step of:

selecting the current amplitude of the treatment input signal from the group consisting of current amplitudes spanning the range from 0.5 mA to 2.5 mA.

23. The method according to claim 21, further characterized by comprising the step of:

selecting the current frequency of the treatment input signal treatment as either one of both 50 KHz to 100 KHz.

24. the method according to claim 21, further characterized by comprising the step of:

selecting the current duration of the treatment input signal from the group consisting of current durations spanning the range from 100 msec to 500 msec.

25. The method according to claim 21, further characterized by comprising the step of:

selecting the treatment input signal to comprise a current amplitude of 1.5 mA, a current frequency of either one of both 50 and 100 KHz and a current duration of 250 msec.

26. The method according to claim 21 or 25, further characterized by comprising the step of:

selecting an injection delay for insertion between the end and the beginning of two successive treatment injection signals injected into two pairs of electrodes (12) out of the least one pair of electrodes as an injection delay selected from the group of delays consisting of a range spanning from 4 msec to 400 msec.

27. The method according to claim 26, wherein

the treatment injection delay duration is selected as 40 msec.

28. The method according to claim 21 further characterized by comprising the steps of:

selecting the treatment input signal as an alternative current signal with predetermined signal current parameters comprising current amplitude, current frequency and current duration for automatic sequential injection of the treatment input signals in pairs of electrodes (12) chosen in predetermined sequence from the array of electrodes.

29. The method according to claim 28, further characterized by comprising the step of:

selecting the treatment input signal to comprise a current amplitude of 1.5 mA, a current frequency of either one of both 50 and 100 KHz, a current duration of 250 msec, and a the treatment injection delay duration of 40 msec.

30. The method according to claim 1 or 20 further characterized by comprising the steps of:

operating a research mode comprising injecting either one of both a research diagnosis input signal and a research treatment input signal in at least one pair of electrodes (12).

31. The method according to claim 30, further characterized by comprising the step of:

selecting the research diagnosis input signal as an alternative current signal with predetermined signal current parameters comprising current amplitude, current frequency and current duration, and

measuring research output signals over the electrodes pair (12) injected with the research diagnosis input signal and over the opposite electrodes pair.

32. The method according to claim 31 further characterized by comprising the steps of:

selecting the research diagnosis input signal current amplitude from the group consisting of 50 microA, 100 microA, 0.5 mA, 1 mA, 2.5 mA and 3 mA.

33. The method according to claim 31, further characterized by comprising the step of:

selecting the research diagnosis input signal current frequency from the group consisting of 10 Hz, 50 Hz, 100 Hz, 500 Hz, 10 KHz, 25 KHz, 50 KHz, and 100 KHz.

34. The method according to claim 31, further characterized by comprising the step of:

selecting the research diagnosis input signal current duration from the group consisting of 2 msec, 10 msec, 100 msec, 250 msec and 500 msec.

35. The method according to claim 31, further characterized by comprising the step of:

selecting an injection delay for insertion between the end and the beginning of two successive diagnosis injection signals from the group of delays consisting of a range spanning from 4 msec to 400 msec.

36. The method according to claim 31, further characterized by comprising the step of:

measuring a research output signal over the pair of electrodes selected for research signal injection within a specific injection delay after starting but before ending of the research signal injection.

37. The method according to claim 31, further characterized by comprising the step of:

measuring a research output signal over the pair of electrodes opposite to the pair of electrodes injected with the research signal injection within a specific opposite delay after starting but before ending of the signal injection.

38. The method according to claim 31, further characterized by comprising the steps of:

selecting a first pair of electrodes (12) for injecting therein a research diagnosis signal, and

selecting a next electrode-pair for injecting therein the research injection signal, and successively injecting the research injection signal in all the combinations of electrode-pairs possible out of the array of electrodes.

39. The method according to claim 31, further characterized by comprising the steps of:

measuring research diagnosis output signals in dimensions selected from the group of dimensions consisting of voltage, frequency, impedance, and resistance and conductance.

40. The method according to any of the claims 31, 5, 16 or 17, further characterized by comprising the steps of:

processing the research diagnosis output signals for display,

displaying the research diagnosis output signals in association with electrode pair designation for detection and diagnosis of mental disorder.

41. A Cranial Electric Stimulator (4), or CES (4), comprising a diagnosis mode, a treatment mode;

a research mode and a test mode and comprising an array of designated electrodes (12) attached in distribution onto the skull (6), the CES (4) being characterized by

a workstation (8) operated by a practitioner (2) and coupled to a signal and routing box, SRB (10), to which the array of electrodes is coupled, further comprising

in the diagnosis mode;

predetermined alternative current diagnosis input signals generated by the SRB under control of the workstation, for successive injection via 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;

predetermined alternative current input treatment signals injected for relief of a condition in signal passage paths detected with a condition,

in the research mode;

selected alternative current research diagnosis input signals permitting injection into and retrieval of output signals from the brain, and selecting injection of alternative current research treatment input signals, and

in the test mode;

the workstation running safety and accuracy checks on the CES (4).

42. The CES (4) according to claim 41, further characterized by

the diagnosis mode and the treatment mode operating in successive cycles of first diagnosis and next treatment, and

the treatment mode being operated for adaptive selection of the injected treatment signals according to the detection achieved in the diagnosis mode.

43. The CES (4) according to claim 41, wherein the diagnosis mode is further characterized by:

diagnosis output signals being retrieved from the array of electrodes (12), measured and displayed in relation to corresponding designated electrode pairs, for detection of signal passage paths displaying a condition, by comparison to either one and combination of same and previous diagnosis mode session results.

44. The CES (4) according to claim 41, wherein an alternative current diagnosis input signals is further characterized by comprising:

a current amplitude of 0.5 mA, a current frequency of 25 KHz and a current duration of 10 msec.

45. The CES (4) according to claim 41, further characterized in that:

the array of electrodes (12) is selected in all possible combinations of electrode pairs and injected sequentially with diagnosis input signals,

each electrode pair has a designated pair of opposite electrodes, and

diagnostic output signals are measured from each combination of pairs of electrodes (12) injected with diagnostic input signals and from each opposite electrodes pair.

46. The CES (4) according to claim 41, further characterized by:

an injection delay of 40 msec being selected for insertion between the end and the beginning of two successive diagnosis input signals injection.

47. The CES (4) according to claim 43, further characterized in that:

a diagnosis output signal is measured over the pair of electrodes selected for diagnosis signal injection within a specific injection delay after starting but before ending of the signal injection.

48. The CES (4) according to claim 47, further characterized in that:

the diagnosis injection delay is selected as 5 msec.

49. The CES (4) according to claim 45, further characterized in that:

the output signal is measured over the pair of electrodes opposite to the pair of electrodes (12) injected with the diagnosis input signal within a specific opposite delay after starting but before ending of the diagnosis signal injection.

50. The CES (4) according to claim 48, further characterized by:

selecting the opposite delay being selected as 7 msec.

51. The CES (4) according to claim 43, further characterized by:

the diagnosis output signals being measured in dimensions selected from the group of dimensions consisting of voltage, frequency, impedance, resistance and conductance.

52. The CES (4) according to claim 43, further characterized by:

the diagnosis output signals being processed for display and displayed in association with electrode pair designation, for detection and diagnosis of mental disorder.

53. The CES (4) according to claim 41, further characterized by:

a treatment mode comprising injecting a treatment input signal in at least one pair of electrodes (12) chosen in accordance with the detection of a signal passage condition achieved in the diagnosis mode.

54. The CES (4) according to claim 53, further characterized in that:

the treatment input signal is selected as an alternative current signal with predetermined signal current parameters comprising;

current amplitude selected from the group consisting of current amplitudes spanning the range from 0.5 niA 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.

55. The CES (4) according to claim 54, further characterized in that:

the treatment input signal is selected to comprise a current amplitude of 1.5 mA, a current frequency of either one of both 50 and 100 KHz, and a current duration of 250 msec.

56. The CES (4) according to claim 54, further characterized in that:

an injection delay is selected for insertion between the end and the beginning of two successive treatment injection signals injected into two pairs of electrodes (12) out of the least one pair of electrodes as an injection delay selected from the group of delays consisting of a range spanning from 4 msec to 400 msec.

57. The CES (4) according to claim 56, further characterized in that:

the treatment injection delay duration is selected as 40 msec.

58. The CES (4) according to claim 54, further characterized in that:

the treatment input signal is selected as an alternative 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 (12) chosen in predetermined sequence from an array of 24 electrodes.