Adaptive brain stimulation method and system

• US 6,066,163 A
• Filed: 02/02/1996
• Issued: 05/23/2000
• Est. Priority Date: 02/02/1996
• Status: Expired due to Term

• Current Assignee: Michael Sasha John
• Original Assignee: Michael Sasha John
• Inventors: John, Michael Sasha
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US08/596,450
• Time in Patent Office: 1,572 Days
• Field of Search: 607/45, 607/48, 607/62, 607/65, 607/72
• US Class Current: 607/45
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36103 Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture

Abstract

An adaptive brain stimulation system and method is described which aids in the rehabilitation of patients from traumatic brain injury, coma, or other brain dysfunction. After a direct brain stimulator is implanted in a brain region of a patient, the patient is stimulated according to a set of stimulation parameters. A present state is measured and compared to a reference state by statistical and medically relevant criteria. The subsequent program of stimulation is dependent upon the outcome of the comparison. An adaptive brain stimulation and reinforcement system and method is also described in which a second area of the brain is stimulated when stimulation of the first brain area produces a desired effect, thereby reinforcing the prior response of the brain.

Claims

1. An adaptive brain stimulation device for treating brain disorder or disfunction comprising:

a. a sensing means including a sensor or a set of sensors for sensing data used to compute a present state of a patient,

b. stimulating means for stimulating a first brain region of the central nervous system of said patient according to a first set of stimulation parameters,

c. comparator means for making a statistical comparison operation between said present state and a reference state, said comparison operation resulting in a positive outcome or a negative outcome,

e. means for adjusting said stimulation parameters according to the outcome of said comparing said present state to said reference state.

2. An adaptive brain stimulation device of claim 1 in which said present state is at least one quantitative measurement that is computed from physiological data that are sensed by at least one sensor, which is implanted within or is external to a patient, said data being sensed during a period of active stimulation or at least one fraction of said period of active stimulation, or during a post-stimulation period, or at least a fraction of said post-stimulation period.

3. An adaptive brain stimulation device of claim 1 in which said present state is computed from physiological data sensed by at least one a sensor which is implanted internally within or are located externally to a patient.

4. An adaptive brain stimulation device of claim 1 wherein said reference state is a set of values selected from a database which contains at least one of the following:

a previous state of said patient, a weighted sum of previous states, a population normative value in a normal state, or under the influence of a pharmacological agent, or a weighted state computed based upon evidence of neuronal damage or other physiological, neuro-anatomical, or neuro-pharmacological characteristics of said patient.

5. An adaptive brain stimulation device of claim 1 wherein said comparison operation is performed between said present state and said reference state, said comparison operation being accomplished in the time domain or in the frequency domain, or on a user defined or calculated threshold value or on a set of threshold values, said comparison operation using a set of statistical criteria and a set of medically meaningful weighting coefficients that may be chosen by medical personnel or which can be selected from a database.

6. An adaptive brain stimulation device of claim 1 wherein stimulating means for stimulating a first brain region comprises a direct brain stimulator set #1, said direct brain stimulator set #1 being comprised of at least one direct brain stimulator.

7. An adaptive brain stimulation device of claim 6 wherein the direct brain stimulator set #1 comprises multiple direct brain stimulators, each being independently activated, and subsequently independently controlled by separate said stimulating parameters.

8. An adaptive brain stimulation device of claim 1 wherein said stimulation parameters include but are not limited to at least pulse amplitude, pulse width, onset and offset times, frequency, a burst firing mode and a non-burst firing mode, AM and FM pulse train type, DC offset, pulse current, polarity, pulse duration, and inter-pulse interval.

9. An adaptive brain stimulation device of claim 1 in which said present state and said reference state are each computed from at least one quantitative measurement that is computed from physiological data that are sensed by said sensing means, said sensing means including at least one sensor located inside of a patient or located fully external to a patient.

10. An adaptive brain stimulation device of claim 1 in which said means for sensing a state includes a sensor which is at least one of the following:

an internally implanted electrode, a conventional scalp EEG electrode, an EMG electrode, an EKG electrode, a pet scanner, a spect scanner, an MRI scanner, an FMRI scanner.

11. An adaptive brain stimulation device of claim 1 in which means for stimulation is at least one of the following:

an electrical means, a magnetic means, or a pharmacological means.

12. An adaptive brain stimulation device of claim 1 in which said means for stimulation comprises either direct stimulation or induced stimulation.

13. An adaptive brain stimulation device of claim 1 which additionally contains safety means for monitoring the autonomic nervous system and for halting said stimulation means if any of a set of vital signs exceeds a value which is deemed to be medically unsafe.

14. An adaptive brain stimulation device of claim 1 in which said means for stimulation includes devices for stimulation of the visual, auditory, or tactile sensory modalities.

15. A method of using the neurological stimulation device of claim 1 which additionally includes detecting a present state that is characterized by certain rhythmic or non-rhythmic change in a subjects temperature, eye movement, EMG, neurochemical (CSF metabolites), or neural activity and only enabling possible stimulation when said rhythmic or non-rhythmic change is detected.

16. An adaptive brain stimulation device comprising:

a. means for sensing a present state of at least a first brain region, or a fist set of brain regions and a second brain region or a second set of brain regions,

b. means for stimulating a first brain region or a first set of brain regions by a direct brain stimulator set #1 according to a first set of stimulation parameters,

c. means for stimulating a second brain region or a second set of brain regions by a direct brain stimulator set #2 according to a second set of stimulation parameters,

d. means for comparing said present state to a reference state, said comparing leading to a positive outcome or a negative outcome,

e. means for adjusting said stimulation parameters according to the outcome of said comparing said present and said reference state.

17. An adaptive brain stimulation device of claim 17 in which said means for stimulation comprises an electrical, magnetic, or pharmacological stimulation means.

18. An adaptive brain stimulation device of claim 17 in which said present state is during a period of active stimulation, during a post-stimulation period or a fraction of said period which occurs prior to or subsequent to said period of active stimulation.

19. An adaptive brain stimulation device of claim 17 in which said present state is computed from at least one quantitative measurement that is computed from data sensed by at least one sensor which is implanted internally within or are located externally to a patient, and are compared to a self norm or a population norm.

20. An adaptive brain stimulation device of claim 17 wherein said reference state is a set of values selected from a database, and is a previous state of said patient, a weighted sum of previous states, a population normative value in a normal state, or under the influence of a pharmacological agent.

21. An adaptive brain stimulation device of claim 17 wherein the means for comparing said present state to said reference state is a statistical comparison operation which may be univariate or multivariate.

22. An adaptive brain stimulation device of claim 17 wherein DBS set #1 is comprised of at least one DBS.

23. An adaptive brain stimulation device of claim 17 wherein DBS set #1 is comprised of multiple DBS'"'"'s which may each be independently activated, and subsequently independently controlled by different said stimulation parameters.

24. An adaptive brain stimulation device of claim 17 wherein said stimulation parameters include but are not limited to pulse amplitude, pulse width, onset and offset times, frequency, a burst firing mode or a non-burst firing mode, AM or FM pulse train type, DC offset, pulse current, inter-pulse interval, relative polarity, and relative latency.

25. A method of using adaptive brain stimulation in the treatment of brain disorder or disfunction which comprises:

a. sensing the present state of several brain regions,

stimulating a first brain region or a first set of brain regions according to a set of stimulation parameters,

c. performing a statistical comparison between the present state and a reference table,

d. changing said stimulation parameters if the comparison fails to meet a criteria, and

e. repeating steps a, b, c, and d.

26. A method of claim 25 which additionally includes the step of stimulating a second brain region or a second set of brain regions if the comparison succeeds in a meeting a criteria.

27. A method of claim 25 which additionally includes the step of providing positive reinforcement by stimulating at least a second brain region if the comparison succeeds in meeting a criteria.

28. A method of treating Parkinson'"'"'s Disease and other movement disorders which comprises:

a. sensing the present state of one or more brain regions and/or peripheral regions,

b. stimulating a first brain region or a first set of brain regions according to a set of stimulation parameters,

c. performing a statistically significant comparison between the present state and a reference state,

d. changing said stimulation parameters if the comparison fails to meet a criteria, and

e. repeating steps a, b, c, and d.

29. A method of claim 28 which additionally includes the step of stimulating a second brain region or a second set of brain regions if the comparison succeeds in meeting a criteria.

30. A method of claim 28 in which the medically significant comparison includes assigning relatively large weighting coefficients to the sensing of said peripheral regions said sensing being accomplished by conventionally located EMG electrodes.