Non-invasive neuromodulation (NINM) for rehabilitation of brain function

• US 8,909,345 B1
• Filed: 07/24/2014
• Issued: 12/09/2014
• Est. Priority Date: 01/04/2008
• Status: Active Grant

• Current Assignee: Kurt A. Kaczmarek, Mitchell E. Tyler, Yuri P. Danilov
• Original Assignee: Kurt A. Kaczmarek, Mitchell E. Tyler, Yuri P. Danilov
• Inventors: Danilov, Yuri P., Kaczmarek, Kurt A., Tyler, Mitchell E.
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): Alter, Alyssa M
• Application Number:
  US14/340,144
• Time in Patent Office: 138 Days
• Field of Search: 607/45, 607/134, 601/21
• US Class Current: 607/45
• CPC Class Codes: A61H 21/00 Massage devices for cavities of the body , e.g. nose, ears and anus for the genitals A61H19/00; Vibration or percussion related aspects A61H23/00
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/0548 Oral electrodes
• CPC Class Codes: A61N 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36078 Inducing or controlling sleep or relaxation non-implantable stimulator A61M21/00
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36092 Mental training
• CPC Class Codes: A61N 1/36096 Mood disorders, e.g. depression, anxiety or panic disorder
• CPC Class Codes: A61N 1/361 Phantom sensations, e.g. tinnitus
• CPC Class Codes: A61N 1/36103 Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke
• CPC Class Codes: G09B 19/00 Teaching not covered by other main groups of this subclass teaching or practice apparatus for gun-aiming or gun-laying F41G3/26

Abstract

In a patient suffering from neural impairment, stimulation is provided to sensory surfaces of the face and/or neck, or more generally to areas of the body that stimulate the trigeminal nerve, while performing an activity intended to stimulate a brain function to be rehabilitated. The simulation may then be continued after the performance of the activity has ceased. It has been found that the patient'"'"'s performance of the activity is then improved after stimulation has ceased. Moreover, it tends to improve to a greater extent, and/or for a longer time, when the post-activity stimulation is applied, as compared to when postactivity stimulation is not applied.

Claims

1. A method for non-invasively assisting neurorehabilitation in a patient comprising:

engaging the patient in a physical movement wherein the patient'"'"'s ability to perform the physical movement is hindered by impairment of the patient'"'"'s nervous system; and

providing intraoral cutaneous stimulation of at least one of the patient'"'"'s trigeminal nerve or the patient'"'"'s facial nerve via one or more stimulators situated within the patient'"'"'s mouth.

2. The method of claim 1 further comprising providing intraoral cutaneous stimulation via one or more stimulators situated within the patient'"'"'s mouth synchronously with the patient'"'"'s engagement in the physical movement.

3. The method of claim 1 further comprising engaging the patient in one or more of the following:

a posture maintaining exercise, a limb movement exercise, or a speech exercise.

4. The method of claim 1 wherein the impairment of the patient'"'"'s nervous system is one or more of traumatic brain injury, stroke, bradykinesia, tremor, apraxia, dysarthria, multiple sclerosis, Parkinson'"'"'s disease, or Alzheimer'"'"'s disease.

5. The method of claim 1 further comprising providing the intraoral stimulation to the patient'"'"'s tongue.

6. The method of claim 5 further comprising providing the intraoral cutaneous stimulation independent of the patient'"'"'s surrounding environment and the patient'"'"'s engagement in the physical movement.

7. The method of claim 1 wherein the engaging step further comprises (i) having the patient perform the physical movement at high intensity and (ii) subsequently having the patient perform the physical movement at moderate intensity, while simultaneously providing the intraoral cutaneous stimulation to the patient'"'"'s tongue.

8. The method of claim 7 wherein the engaging step further comprises having the patient perform the physical movement at low intensity before performing the physical movement at high intensity.

9. The method of claim 5 further comprising providing the intraoral cutaneous stimulation during one or more of a period shortly or immediately after the patient has engaged in the physical movement or a period shortly or immediately prior to having the patient engage in the physical movement, without taking measurements of electrical activity of the patient'"'"'s brain during the one or more periods.

10. The method of claim 5 further comprising providing the intraoral cutaneous stimulation to the patient'"'"'s tongue via the stimulators without having the patient engage in the physical movement.

11. The method of claim 5 further comprising providing the intraoral cutaneous stimulation to the patient'"'"'s tongue by electrical pulses delivered by the stimulators.

12. The method of claim 11 further comprising providing the electrical pulses independent of the patient'"'"'s surrounding environment and the patient'"'"'s engagement in the physical movement.

13. The method of claim 11 further comprising providing the electrical pulses at an intensity level beneath the patient'"'"'s threshold of sensory perception.

14. The method of claim 11 further comprising delivering the stimulation with an array of electrodes, the electrodes being in electrical communication with a pattern generator.

15. The method of claim 14 wherein each electrode has a surface configured for cutaneous mounting on the patient'"'"'s tongue.

16. The method of claim 14 further comprising delivering via the pattern generator electrical pulses to the electrodes in a pattern that is independent of the patient'"'"'s surrounding environment and the patient'"'"'s engagement in the physical movement.

17. The method of claim 14 further comprising delivering via the pattern generator electrical pulses to the electrodes in a random or repeating pattern that is independent of events occurring outside the device during delivery of the electrical pulses.

18. The method of claim 5 further comprising providing a mouthpiece configured to be worn by the patient and having the stimulators arrayed on at least one surface of the mouthpiece.

19. The method of claim 5 further comprising placing movable actuators intraorally within the patient'"'"'s mouth and applying motion to the interior of the patient'"'"'s mouth via the actuators.

20. The method of claim 5 further comprising providing a mouthpiece configured to be worn by the patient, the mouthpiece having electrodes configured to be cutaneously mounted on the patient.

21. A method for providing non-invasive neurorehabilitation therapy to a patient, the method comprising:

(a) engaging the patient in a physical movement at a first intensity for a first time interval;

(b) applying intraoral cutaneous stimulation to the patient'"'"'s trigeminal nerve and facial nerve via one or more stimulators situated within the patient'"'"'s mouth during the first time interval;

(c) engaging the patient in a physical movement at a second intensity for a second time interval;

(d) applying intraoral cutaneous stimulation to the patient'"'"'s trigeminal nerve and facial nerve via one or more stimulators situated within the patient'"'"'s mouth during the second time interval;

(e) engaging the patient in a physical movement at a third intensity for a third time interval;

(f) applying intraoral cutaneous stimulation to the patient'"'"'s trigeminal nerve and facial nerve via one or more stimulators situated within the patient'"'"'s mouth during the third time interval;

(g) engaging the patient in a physical movement at a fourth intensity for a fourth time interval; and

(h) applying intraoral cutaneous stimulation to the patient'"'"'s trigeminal nerve and facial nerve via one or more stimulators situated within the patient'"'"'s mouth during the fourth time interval.

22. The method of claim 21 wherein the first intensity is a low intensity, the second intensity is a high intensity, the third intensity is a moderate intensity, and the fourth intensity is a moderate intensity.

23. The method of claim 22 wherein the first time interval is a short time interval, the second time interval is a short time interval, the third time interval is a short time interval, and the fourth time interval is a long time interval.

24. The method of claim 23 further comprising repeating steps (a)-(h) at least twice per day.

25. The method of claim 21 further comprising measuring the patient'"'"'s current health and functional state.

26. The method of claim 21 further comprising conditioning the patient within the limits of the patient'"'"'s initial ability without any stimulation being applied.

27. The method of claim 21 further comprising subsequently measuring the patient'"'"'s current health and functional state to assess the efficacy of the non-invasive neurorehabilitation therapy.

28. A method for non-invasively assisting neurorehabilitation in a patient comprising:

engaging the patient in a physical movement wherein the patient'"'"'s ability to perform the physical movement is hindered by impairment of the patient'"'"'s nervous system; and

providing intraoral cutaneous stimulation of the patient'"'"'s trigeminal nerve and the patient'"'"'s facial nerve via one or more stimulators situated within the patient'"'"'s mouth.