Apparatus and methods for titrating caloric vestibular stimulation

• US 9,861,519 B2
• Filed: 12/16/2011
• Issued: 01/09/2018
• Est. Priority Date: 12/16/2010
• Status: Active Grant

• Current Assignee: Scion Neurostim Incorporated
• Original Assignee: Scion Neurostim, LLC
• Inventors: Rogers, Lesco L., Smith, Lanty L., Black, Robert D.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): Zink, Amanda
• Application Number:
  US13/990,622
• Publication Number:
  US 20130310907A1
• Time in Patent Office: 2,216 Days
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61F 2007/0005 Ears
• CPC Class Codes: A61F 2007/0075 using a Peltier element, e.g. near the spot to be heated or cooled
• CPC Class Codes: A61F 2007/0093 programmed
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• CPC Class Codes: A61F 2007/0096 with a thermometer
• CPC Class Codes: A61F 2007/0296 Intervals of heating alternated with intervals of cooling
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61N 1/36036 of the outer, middle or inner ear
• CPC Class Codes: A61N 2/002 in combination with another treatment
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue

Abstract

A device for delivering caloric vestibular stimulation to an individual, includes: (a) an earpiece configured to be at least partially insertable into the ear canal of the individual for delivering a first thermal stimulus; (b) an input unit for receiving a user input indicating efficacy of said first thermal stimulus, and (c) a controller operatively associated with said earpiece and said input unit for: (i) controlling said earpiece to provide said first thermal stimulus, and (ii) receiving a signal corresponding to the user input and generating a control signal to control the earpiece and delivering a subsequent thermal stimulus different from said first thermal stimulus. In some embodiments, each thermal stimulus is an actively controlled time varying waveform stimulus.

Claims

1. A device for delivering caloric vestibular stimulation to an individual, comprising:

(a) an earpiece configured to be at least partially insertable into the ear canal of the individual for delivering a first thermal stimulus;

(b) an input unit for receiving a user input indicating efficacy of said first thermal stimulus, and

(c) a controller operatively associated with said earpiece and said input unit for;

(i) controlling said earpiece to provide said first thermal stimulus, and

(ii) receiving a signal corresponding to the user input and generating a control signal to control the earpiece and delivering a subsequent thermal stimulus different from said first thermal stimulus,

wherein the vestibular stimulation is sufficient to induce nystagmus such that the nystagmus is substantially present over a period of at least five minutes.

2. The device of claim 1, wherein said input unit comprises a touch screen.

3. The device of claim 1, further comprising a heat sink operatively associated with said earpiece and a power supply operatively associated with said controller.

4. The device of claim 1, wherein said earpiece is comprised of metal.

5. The device of claim 1, further comprising:

(d) a thermoelectric device connected to said earpiece, wherein said earpiece is operatively associated with said controller through said thermoelectric device.

6. The device of claim 2, further comprising:

(e) a temperature sensor thermally connected to said earpiece and operatively associated with said controller;

and wherein said controller delivers said thermal stimulus as actively controlled time varying waveforms responsive to said temperature sensor.

7. The device of claim 6, wherein said at least a first and second time-varying waveform comprises from 3 to 10 sequential waveforms.

8. The device of claim 6, wherein each of said time varying waveforms comprises a ramped leading edge and/or a ramped trailing edge.

9. The device of claim 6, wherein each of said time varying waveforms, which may be the same or different, has a duration of from 1 minute to 20 minutes and an amplitude of from 5 to 24 degrees Centigrade.

10. The device of claim 6, wherein said time varying waveforms are delivered in a sequence in a treatment session, said treatment session having a total duration of five to 20 minutes.

11. A method of titrating caloric vestibular stimulation, comprising:

(a) selecting a first thermal stimulus for a caloric vestibular stimulator;

(b) selecting a subsequent thermal stimulus for the caloric vestibular stimulator different from the previously selected stimulus pattern, wherein said subsequent thermal stimulus is selected based on the efficacy of the first or previous thermal stimulus,

wherein the vestibular stimulation is sufficient to induce nystagmus such that the nystagmus is substantially present over a period of at least five minutes.

12. The method of claim 11, further comprising the step of assessing or observing efficacy of said first thermal stimulus.

13. The method of claim 12, wherein said step of assessing or observing efficacy comprises detecting at least one physiological parameter.

14. The method of claim 13, wherein said physiological parameter is selected from the group consisting of nystagmography data, blood A1c data, EEG data, MRI data, pulse oximetry data, blood pressure data, GSR data, blood chemistry data, blood glucose data, heart rate data, heart rate variability data, saliva chemistry data, urine chemistry data, and cerebral blood flow data.

15. The method of claim 11, wherein said step of selecting a subsequent stimulus pattern is carried out from a predetermined set of stimulus patterns.

16. The method of claim 15, further comprising the step of modifying a selected member of said predetermined set based on observed efficacy of the prior selected stimulus pattern.

17. The method of claim 11, further comprising:

iteratively repeating step based on assessed or observed efficacy.

18. The method of claim 17, further comprising:

terminating said iterative repetition when one or more termination criteria are met.

19. The method of claim 17, wherein said iterative repetition is carried out in the course of a chronic program of treating a subject with said caloric vestibular stimulator.

20. The method of claim 11, wherein each thermal stimulus is an independently selected waveform stimulus.

21. The method of claim 11, wherein at least one of said subsequent thermal stimulus or stimuli is a time-varying waveform stimulus.

22. The method of claim 21, wherein at least one, or a plurality, of said waveform stimulus or stimuli comprises a first time-varying waveform followed by at least a second time-varying waveform.

23. The method of claim 22, wherein each of said first and second time varying waveforms, which may be the same or different, has a duration of from 1 minute to 20 minutes and an amplitude of from 5 to 24 degrees Centigrade.

24. The method of claim 11, wherein said first thermal stimulus comprises a cooling stimulus.

25. The method of claim 11, wherein said first thermal stimulus and said subsequent thermal stimulus are delivered through the same caloric vestibular stimulation apparatus.

26. The method of claim 11, wherein said first and/or subsequent thermal stimulus are configured to maintain a vestibular stimulation of the subject for at least five minutes.

27. The method of claim 21, further comprising administering a subject said first thermal stimulus and said subsequent thermal stimulus.

28. A computer-readable medium comprising instructions to cause a processor to carry out a method according to claim 11.

29. A device comprising a processor programmed to carry out a method according to claim 11.

30. A method of treating a subject in need thereof, comprising:

(a) administering said subject a first thermal stimulus with a caloric vestibular stimulator;

(b) assessing or observing efficacy of the selected stimulus pattern; and

then

(c) administering said subject a subsequent thermal stimulus with the caloric vestibular stimulator, said subsequent thermal stimulus different from the previously selected stimulus pattern,

wherein the first and subsequent thermal stimulus is configured to induce vestibular stimulation that is sufficient to induce nystagmus such that the nystagmus is substantially present over a period of at least five minutes.

31. The method of claim 30, wherein said step of assessing or observing efficacy comprises detecting at least one physiological parameter.

32. The method of claim 31, wherein said at least one physiological parameter is selected from the group consisting of nystagmography data, blood A1c data, EEG data, MRI data, pulse oximetry data, blood pressure data, GSR data, blood chemistry data, saliva chemistry data, blood glucose data, heart rate variability data, urine chemistry data, and cerebral blood flow data.

33. The method of claim 30, wherein said step of selecting a subsequent stimulus pattern is carried out from a predetermined set of stimulus patterns.

34. The method of claim 33, further comprising the step of modifying a selected member of said predetermined set based on observed efficacy of the prior selected stimulus pattern.

35. The method of claim 30, further comprising:

(d) iteratively repeating steps (b) to (c) based on assessed or observed efficacy.

36. The method of claim 35, further comprising:

(e) terminating said iterative repetition when one or more termination criteria are met.

37. The method of claim 35, wherein said iterative repetition is carried out in the course of a chronic program of treating a subject with said caloric vestibular stimulator.

38. The method of claim 30, wherein each thermal stimulus is an independently selected waveform stimulus.

39. The method of claim 30, wherein at least one of said subsequent thermal stimulus or stimuli is a time-varying waveform stimulus.

40. The method of claim 39, wherein at least one, or a plurality, of said waveform stimulus or stimuli comprises a first time-varying waveform followed by at least a second time-varying waveform.

41. The method of claim 40, wherein each of said first and second time varying waveforms, which may be the same or different, has a duration of from 1 minute to 20 minutes and an amplitude of from 5 to 24 degrees Centigrade.

42. The method of claim 30, wherein said first thermal stimulus comprises a cooling stimulus.

43. The method of claim 30, wherein said first thermal stimulus and said subsequent thermal stimulus are delivered through the same caloric vestibular stimulation apparatus.

44. The method of claim 30, wherein said first and/or subsequent thermal stimulus are configured to maintain a vestibular stimulation of the subject for at least five minutes.

45. A computer-readable medium comprising instructions to cause a processor to carry out a method according to claim 30.

46. A device comprising a processor programmed to carry out a method according to claim 30.