Methods of treating traumatic brain injury by vagus nerve stimulation

• US 6,104,956 A
• Filed: 05/30/1997
• Issued: 08/15/2000
• Est. Priority Date: 05/31/1996
• Status: Expired due to Term

• Current Assignee: Southern Illinois University (Board of Trustees of Southern Illinois University)
• Original Assignee: Board of Trustees of Southern Illinois University
• Inventors: Smith, Douglas C., Jensen, Robert A., Terry, Reese S. Jr., Clark, Kevin B., Browning, Ronald A., Naritoku, Dean K.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US08/866,800
• Time in Patent Office: 1,173 Days
• Field of Search: 607/44, 607/45
• US Class Current: 607/45
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset

Abstract

Methods of modulating brain neural plasticity, improving memory and learning, improving recovery from traumatic brain injury, preventing epilepsy, treating memory disorders and chronic memory impairment, and treating persistent impairment of consciousness in humans and animals by vagus nerve stimulation are provided. These methods comprise selecting an appropriate human or animal subject and applying to the subject'"'"'s vagus nerve an electrical stimulation signal having parameter values effective in modulating the electrical activity of the vagus nerve in a manner so as to modulate the activity of preselected portions of the brain.

Claims

1. A method of treating a human or animal subject suffering from a symptom caused by traumatic brain injury or characteristic of traumatic brain injury, comprising:

(a) applying to the vagus nerve of a human or animal subject suffering from a symptom caused by traumatic brain injury or characteristic of traumatic brain injury a stimulating electrical signal having parameters sufficient to alleviate said symptom;

(b) monitoring said human or animal subject by clinical outcome, a clinical test, a laboratory test, or combinations thereof to determine if said symptom has been alleviated, or if farther stimulation of said vagus nerve is required,

wherein said laboratory test is selected from the group consisting of a brain scan, a PET scan, a SPECT scan, monitoring the level of a neurotransmitter in the brain, and monitoring the level of a neurotransmitter in spinal fluid; and

(c) if required, further stimulating said vagus nerve and monitoring said human or animal subject as in preceding steps (a) and (b), respectively, until said symptom has been alleviated.

2. The method of claim 1, wherein said traumatic brain injury is associated with a member selected from the group consisting of a blow to the head, a penetrating injury to the head, a fall, a skull fracture, an injury due to sudden acceleration, and an injury due to sudden deceleration.

3. The method of claim 1, wherein said symptom is selected from the group consisting of impaired level of consciousness, impaired cognition, impaired cognitive processing speed, impaired language, impaired motor activity, impaired memory, impaired motor skills, and impaired sensory skills.

4. The method of claim 1, wherein said electrical signal is produced by a stimulus generator implanted within said human or animal subject'"'"'s body.

5. The method of claim 1, wherein said stimulating electrical signal is applied to said vagus nerve any time after appearance of said symptom.

6. The method of claim 1, wherein commencement of application of said stimulating electrical signal to said vagus nerve is performed within a time period of from about 1 hour to about 3 months after appearance of said symptom.

7. The method of claim 1, wherein said electrical signal supplies a current to said vagus nerve in the range of from about 0.1 mA to about 10 mA.

8. The method of claim 1, wherein said electrical signal supplies a current to said vagus nerve in the range of from about 0.1 mA to about 4 mA.

9. The method of claim 1, wherein said electrical signal comprises a train of pulses, each pulse of which has a pulse width in the range of from about 50 μ

sec. to about 1,500 μ

sec.

10. The method of claim 1, wherein said electrical signal comprises a train of pulses, each pulse of which has a pulse width in the range of from about 400 μ

sec. to about 750 μ

sec.

11. The method of claim 1, wherein said electrical signal comprises a train of pulses having a frequency in the range of from about 1 Hz to about 75 Hz.

12. The method of claim 1, wherein said electrical signal comprises a train of pulses having a frequency in the range of from about 10 Hz to about 40 Hz.

13. The method of claim 1, wherein said electrical signal is monophasic, biphasic, or a combination thereof.

14. The method of claim 1, wherein said electrical signal comprises a train of pulses, having a train duration in the range of from about 1 second to about 4 hours.

15. The method of claim 14, wherein trains are supplied on demand.

16. The method of claim 1, wherein said electrical signal comprises a train of pulses, having a train duration in the range of from about 5 seconds to about 1 hour.

17. The method of claim 1, wherein said electrical signal comprises trains of pulses, having an interval between trains in the range of from about 1 second to about 1 week.

18. The method of claim 1, wherein said electrical signal comprises trains of pulses, having an interval between trains in the range of from about 5 seconds to about 4 hours.

19. The method of claim 1, wherein said clinical test is selected from the group consisting of activities of daily living, memory, cognition, motor skills, development of epilepsy, and FIM score.

20. The method of claim 1, wherein said treating is performed in a time period in the range of from about one day to as long as continued clinical improvement is obtained.

21. A method of treating a human or animal subject suffering from a symptom caused by traumatic brain injury or characteristic of traumatic brain injury, comprising:

(a) applying to the vagus nerve of a human or animal subject suffering from a symptom caused by traumatic brain injury or characteristic of traumatic brain injury a stimulating electrical signal having parameters sufficient to alleviate said symptom,

wherein said symptom is selected from the group consisting of impaired cognition, impaired cognitive processing speed, impaired language, impaired motor activity, impaired memory, impaired motor skills, and impaired sensory skills;

(b) monitoring said human or animal subject to determine if said symptom has been alleviated, or if further stimulation of said vagus nerve is required; and

(c) if required, further stimulating said vagus nerve and monitoring said human or animal subject as in preceding steps (a) and (b), respectively, until said symptom has been alleviated.

22. The method of claim 21, wherein said monitoring of step (b) is performed via a member selected from the group consisting of clinical outcome, a clinical test, a laboratory test, and combinations thereof.

23. The method of claim 22, wherein said clinical test is selected from the group consisting of activities of daily living, memory, cognition, motor skills, development of epilepsy, and FIM score.

24. The method of claim 22, wherein said laboratory test is selected from the group consisting of a brain scan, a PET scan, a SPECT scan, an EEG, an evoked potential, monitoring the level of a neurotransmitter in the brain, and monitoring the level of a neurotransmitter in spinal fluid.