Apparatus and methods for producing brain activation via the vestibular system with time-varying waveforms

• US 9,849,026 B2
• Filed: 12/16/2011
• Issued: 12/26/2017
• 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:
  US13/990,274
• Publication Number:
  US 20130317576A1
• Time in Patent Office: 2,202 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 said caloric vestibular stimulation; (b) a power supply operatively associated with said earpiece; and (c) a controller operatively associated with said power supply and said earpiece for configuring said caloric vestibular stimulation as at least a first and second time-varying waveform. Preferably, the waveforms are actively controlled waveforms.

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 said caloric vestibular stimulation;

(b) a power supply operatively associated with said earpiece; and

(c) a controller operatively associated with said power supply and said earpiece for configuring said caloric vestibular stimulation as at least a first and second time-varying waveform configured to induce nystagmus such that the nystagmus is substantially present over a period of at least four minutes.

2. 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.

3. 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 time-varying waveforms as actively controlled time varying waveforms responsive to said temperature sensor.

4. The device of claim 1, further comprising:

(f) a heat sink operatively associated with said earpiece.

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

6. The device of claim 1, wherein said at least a first and second time-varying waveform comprises from 3 to 10 sequential waveforms.

7. The device of claim 1, wherein each of said time varying waveforms comprises a ramped leading edge and/or a ramped trailing edge.

8. The device of claim 1, 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.

9. The device of claim 1, 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.

10. The device of claim 1, further comprising:

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

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

wherein said controller delivers said time-varying waveforms as actively controlled time varying waveforms responsive to said temperature sensor; and

(f) a heat sink operatively associated with said earpiece, and wherein;

said earpiece is comprised of metal; and

said at least a first and second time-varying waveform consists of from 3 to 10 sequential waveforms having a ramped leading edge, a ramped trailing edge, and an amplitude of from 5 to 24 degrees Centigrade, which sequential waveforms are delivered in a treatment session having a duration of five to 20 minutes and are configured to induce nystagmus such that the nystagmus is substantially present over a period of at least four minutes.

11. The device of claim 1, wherein said time varying waveforms are administered so that saturation of vestibular nerve activation in said individual is reduced.

12. The device of claim 11, wherein said time varying waveforms are administered so that activation of a fastigial nucleus in said individual is enhanced.

13. A method of administering caloric vestibular stimulation to a subject in need thereof, comprising:

administering caloric vestibular stimulation (CVS) to said subject in a treatment-effective amount,

said caloric vestibular stimulation comprising at least a first and a second actively controlled time varying waveform stimulus configured to induce nystagmus such that the nystagmus is substantially present over a period of at least four minutes.

14. The method of claim 13, wherein:

(a) said subject is afflicted with a condition associated with a mitochondrial disorder or myopathy;

(b) said subject is afflicted with a condition selected from the group consisting of Parkinson'"'"'s disease, migraine headache, depression, anxiety, type II diabetes, dementia, spatial neglect, seizures, and post-traumatic stress disorder;

or

(d) said CVS is administered in an amount effective to enhance cognition or cognitive reserve in said subject.

15. The method of claim 13, wherein said at least a first and second time-varying waveform comprises from 3 to 10 sequential waveforms.

16. The method of claim 13, wherein each of said time varying waveforms comprises a ramped leading edge and/or a ramped trailing edge.

17. The method of claim 13, 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.

18. The method of claim 13, 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.

19. The method of claim 13, wherein said time varying waveforms are administered so that saturation of vestibular nerve activation in said individual is reduced.

20. The method of claim 13, wherein said at least a first and second time-varying waveform consists of from 3 to 10 sequential waveforms having a ramped leading edge, a ramped trailing edge, and an amplitude of from 5 to 24 degrees Centigrade, which sequential waveforms are delivered in a treatment session having a duration of five to 20 minutes.