CRANIAL ELECTROSTIMULATION DEVICE FOR TREATMENT OF POLYSUBSTANCE ADDICTION AND METHOD OF USE

20100100155

12/582574

October 20, 2009

The cranial electrostimulation devices described herein are suitable for use in detoxification from and amelioration of the symptoms of acute and chronic withdrawal from simultaneous multiple addictive substances by transcutaneous electric nerve stimulation. A plurality of time-division multiplexed analog waveforms is applied to the mastoid process of a person in need thereof, thereby treating symptoms of withdrawal from addictive substances. The invention also provides a protocol for encoding a plurality of different waveforms combined sequentially or simultaneously, as well as an improved cranial electrostimulation apparatus having a stable output waveform signal over the useful service life of the power supply, e.g., the battery.

Moyer, Eric P. (Huntington Beach, CA, US); Winston, Joseph R. (Chapel Hill, NC, US)

SEABOARD ASSETS CORP. (Medford, NJ, US)

1. A method of cranial electrostimulation for detoxification from and amelioration of symptoms of acute and chronic withdrawal from simultaneous multiple addictive substances comprising administering a time-division multiplexed plurality of analog waveforms to a person in need thereof, wherein each waveform of said plurality of analog waveforms is defined by an alternating electric current encoding a therapeutic protocol selected for the treatment or prevention of symptoms of withdrawal from one or more addictive substances.

2. The method according to claim 1, wherein said administering step comprises administering a first time-division multiplexed plurality of analog waveforms, and thereafter administering a second time-division multiplexed plurality of analog waveforms.

3. The method according to claim 1, wherein said administering step comprises contacting two electrodes to the mastoid process of said person, wherein said plurality of analog waveforms is administered to said person via said electrodes.

4. The method according to claim 1, wherein said time-division multiplexed plurality of analog waveforms is administered for a duration of from between about 30 minutes to about 14 days.

5. The method according to claim 1, wherein each waveform of said plurality of analog waveforms is unique.

6. The method according to claim 1, wherein each waveform of said plurality of analog waveforms has a cycle time of between about 1 min to about 30 minutes.

7. The method according to claim 1, wherein each waveform of said plurality of analog waveforms are administered in successive frames of equal time.

8. The method according to claim 7, wherein said successive frames are each subdivided into timeslots.

9. The method according to claim 1, wherein each waveform of said plurality of analog waveforms is administered in timeslots of a time length specific to each waveform.

10. The method according to claim 1, wherein said plurality of analog waveforms comprises at least a first waveform and at least a second waveform.

11. The method according to claim 10, wherein said first waveform is administered in timeslots of a first time length, and said second waveform is administered in timeslots of a second time length, said first time length and said second time length being of equal or unequal times.

12. The method according to claim 1, wherein at least one waveform of said plurality of analog waveforms encodes a protocol for the detoxification from and amelioration of the symptoms of acute and/or chronic withdrawal from a first addictive substance.

13. The method according to claim 1, wherein at least one waveform of said plurality of analog waveforms encodes a protocol for the detoxification from and amelioration of the symptoms of acute and/or chronic withdrawal from a second addictive substance.

14. The method according to claim 1, wherein said waveform is defined by one or more frequencies, pulse widths, amplitudes, or waveform shapes.

15. A cranial electrostimulation apparatus comprising a power supply configured to generate a DC power signal; a signal generator configured to generate a control signal for modulating said power signal corresponding to a waveform adapted to provide therapeutic value to a patient; a voltage regulator coupled to receive said DC power signal from said power supply and output a regulated DC voltage signal; a line driver configured to receive as inputs said control signal and said regulated DC voltage signal and generate an output waveform signal by modulating said regulated DC power signal with the control signal; and electrodes coupled to receive said output waveform signal.

16. The apparatus according to claim 15, wherein said voltage regulator maintains said regulated DC voltage within a predetermined range as said DC power signal changes over the useful service duration of said power supply.

17. The apparatus according to claim 16, wherein said power supply is a battery.

18. The apparatus according to claim 17, wherein said control signal is adapted to encode a therapeutic protocol for one of treatment and prevention of symptoms of withdrawal from one or more addictive substances.

19. The apparatus according to claim 17, further comprising a manually operable voltage control circuit coupled between said power supply and said electrodes for permitting a user to adjust the amplitude of the output waveform signal.

20. The apparatus according to claim 17, further comprising a voltage follower circuit coupled between said voltage regulator circuit and said line driver.

21. The apparatus according to claim 17, further comprising a modulator circuit coupled to receive said control signal and said regulated DC voltage signal and output to said line driver a modified control signal comprising said regulated DC voltage signal modulated by said control signal.

22. The apparatus according to claim 17, further comprising a transformer coupled between said line driver and said electrodes.

23. The apparatus according to claim 17, wherein said signal generator is coupled to receive said DC power supply signal and generate said control signal therefrom.

24. The apparatus according to claim 17, further comprising a multiplexer configured for time-division multiplexing a plurality of waveforms into said output waveform signal.

25. A method of encoding a definition of a protocol for generating an analog signal for cranial stimulation comprised of a plurality of different waveforms combined sequentially or simultaneously, the method comprising creating a dataset comprising a first segment defining each waveform of the plurality of waveforms; and a second segment comprising an event definition for each different waveform segment presented without cessation in said analog signal, the event definitions organized sequentially in the dataset according to the relative time at which the corresponding waveform segment starts within the protocol; wherein each event definition comprises a duration field disclosing the duration of said waveform segment; a start_delta field disclosing the start time of the event, start time defined as a delay period following the start time of an immediately preceding event definition in said dataset and by zero for the first event definition in said dataset; and a waveform identifier field identifying one of the plurality of waveforms for the waveform segment.

26. The method according to claim 25, wherein each event definition further comprises a modifier field disclosing special properties of said waveform segment.

27. The method according to claim 25, wherein each data field in the event definitions has a single predetermined number of bits.

28. The method according to claim 27, wherein said duration field represents the duration of said waveform segment as a number representing a number of predetermined time intervals and wherein, when a duration of a waveform segment exceeds the maximum amount of time that can be represented by corresponding predetermined number of bits dedicated to that data field, said waveform segment is represented in said dataset by a plurality of event definitions.

29. The method according to claim 26, wherein, if a waveform segment starts at the same time as the waveform segment defined in the immediately preceding event definition, the corresponding start_delta field is set to zero.

30. The method according to claim 26, further comprising an end bit sequence representing the end of said event definition segment of said dataset.

31. The method according to claim 30, wherein said end bit sequence comprises an event definition in which said duration field contains a value corresponding to a duration of zero.

32. The method according to claim 31, wherein said event definition segment succeeds the waveform definition segment of said dataset and said end bit sequence further indicates the end of said dataset.

33. The method according to claim 26, further comprising a treatment description segment.

34. A method of downloading a definition of a protocol for generating an analog signal for cranial stimulation comprised of a plurality of different waveforms combined sequentially or simultaneously to a cranial electrostimulation device, the method comprising connecting the CES device to a source of protocol definitions; and receiving from the source a dataset comprising a first segment defining each waveform of the plurality of waveforms; and a second segment comprising an event definition for each different waveform segment presented without cessation in said analog signal, the event definitions organized sequentially in the dataset according to the relative time at which the corresponding waveform segment starts within the protocol; wherein each event definition comprises a duration field disclosing the duration of said waveform segment; a start_delta field disclosing the start time of the event, start time defined as a delay period following the start time of an immediately preceding event definition in said dataset and by zero for the first event definition in the dataset; and a waveform identifier field identifying one of the plurality of waveforms for the waveform segment.

35. The method according to claim 34, wherein each data field in the event definitions has a single predetermined number of bits.

36. The method according to claim 35, wherein said duration field represents the duration of said waveform segment as a number representing a number of predetermined time intervals and wherein, when a duration of a waveform segment exceeds the maximum amount of time that can be represented by corresponding predetermined number of bits dedicated to that data field, said waveform segment is represented in said dataset by a plurality of event definitions.

37. The method according to claim 36, further comprising an end bit sequence representing the end of said event definition segment of said dataset, wherein said end bit sequence comprises an event definition in which said duration field contains a value corresponding to a duration of zero.

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edspap.20100100155