Adaptive brain stimulation method and system

• US 6,463,328 B1
• Filed: 01/10/2000
• Issued: 10/08/2002
• 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): LAYNO, CARL HERNANDZ
• Application Number:
  US09/480,052
• Time in Patent Office: 1,002 Days
• Field of Search: 607/45, 607/53, 607/55, 607/58
• 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 1/36135 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

Adaptive brain stimulation systems and methods aids in the rehabilitation of patients from traumatic brain injury, coma, movement disorder, 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 system for treating a brain disorder or dysfunction of a patient comprising:

a. one or more sensors of biological activity coupled with a patient to sense a present state of a patient;

b. stimulating circuits coupled with the patient to stimulate a first brain region of the central nervous system of the patient according to a first set of stimulation parameters;

c. comparator circuits coupled with the one or more sensors to receive present state data therefrom regarding the present state of the patient and to carry out a statistical comparison operation between the present state data and reference state data, said comparison operation resulting in a positive outcome or a negative outcome; and

e. adjusting circuits coupled to the comparator circuits to receive data therefrom regarding said positive or negative outcome and coupled to the stimulating circuits to adjust the stimulation parameters according to the outcome of said comparison of the present state data and the reference state data.

2. An adaptive brain stimulation system as in claim 1 in which the one or more sensors are implanted within or are external to the patient and sense a present state data related to a measurement or set of measurements 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 system as in claim 1 in which the present state data relate to measures sensed by the sensor or set sensors implanted internally within or located externally to a patient.

4. An adaptive brain stimulation system as in claim 1 wherein the reference state data are selected from a database which contains at least one the following:

a previous state of the patient, a weighted sum of previous states, a population normative value in a normal state, a stimulation “

on”

state, a stimulation “

off”

state, or under the influence of a pharmacological agent, or a weighted state computed based upon evidence of neuronal damage or other physiological, neuroanotomical, or neuropharmacological characteristics of said patient.

5. An adaptive brain stimulation system as in claim 1 wherein said comparison operation is performed between the present state data and the reference state data in the time domain or in the frequency domain, or on a transform of or fraction of said time or 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 weighing coefficients chosen by medical personnel or selected from said database.

6. An adaptive brain stimulation system as in claim 1 wherein the stimulating circuits comprise a DBS set #1, said DBS set #1 being comprised of at least one DBS.

7. An adaptive brain stimulation system as in claim 6 wherein DBS set #1 comprises multiple DBS'"'"'s, each independently activated and subsequently independently controlled by separate ones of the stimulation parameters.

8. An adaptive brain stimulation system as in claim 1 wherein the stimulation parameters include pulse amplitude, pulse width, onset and offset times, frequency, a burst firing mode and a non-burst firing mode, AM and FM state, DC offset, output current, output voltage, relative polarity, and relative latency.

9. An adaptive brain stimulation system as in claim 1 in which the present state data are obtained when the one or more sensors are partially or fully implanted inside of the patient or located fully external to the patient.

10. An adaptive brain stimulation system as in claim 1 in which the one or more sensors include at least one of the following:

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

11. An adaptive brain stimulation system as in claim 1 in which the stimulating circuits comprise circuits providing at least one of the following types of stimulation:

electrical, magnetic, and pharmacological.

12. An adaptive brain stimulation system as in claim 1 in which the stimulating circuits provide direct stimulation or stimulation by induction.

13. An adaptive brain stimulation system as in claim 1 further including a monitoring circuits coupled with the stimulating circuits and with the patient to monitor the autonomic nervous system thereof and halt or reduce the operation of the stimulating circuits if vital signs of the patient become medically unsafe.

14. An adaptive brain stimulation system as in claim 1 in which the stimulating circuits provide at least one of the following types of stimulation:

visual, auditory, and tactile sensory stimulation.

15. A method of using the neurological stimulation system of claim 1, further including detecting a present state characterized by selected rhythmic or non-rhythmic changes in one or more of the patient'"'"'s temperature, eye movement, neurochemical (CSF metabolites), or neural activity, and only enabling stimulation when said rhythmic or non-rhythmic changes are detected.

16. An adaptive brain stimulation system as in claim 1 comprising a controller external to the patient and comprising power source, data memory, telemetry arrangement, display, and interface devices, said controller including said comarator and adjusting circuits and enabling patients to modify neurostimulation to re-initialize stimulation parameters to initial settings by medical personnel and to select from sets of parameters set by medical personnel and to store current parameters when they produce a subjective desired result and to choose from past stimulation parameters that achieved desired results, and to select a program of stimulation in which the parameters cycle between a number of past stimulation parameters that achieved desired subjective results or past desired comparison results, and to halt stimulation or sensing or both during rigorous activity or prior to sleep, and to halt stimulation for a desired time interval.

17. An adaptive brain stimulation system as in claim 16 in which at least a portion of said controller is contained in a hand-held device communicating wirelessly with system components implanted in the patient.

18. An adaptive brain stimulation system comprising:

a. biological sensors coupled with a patient to sense a present state of at least a first brain region or a first set of brain regions and a second brain region or a second set of brain regions of a patient;

b. first stimulating circuits coupled with a first brain region or a first set of brain regions of the patient by a DBS set #1 to carry out stimulation according to a first set of stimulation parameters;

c. second stimulating circuits coupled with a second brain region or a second set of brain regions of the patient by a DBS set #2 to carry out stimulation according to a second set of stimulation parameters;

d. a comparator coupled with the sensors to receive data related to said present state and compare the present set data with reference state data, said comparing leading to a positive outcome or a negative outcome;

e. adjusting circuits coupled with the first and second stimulating circuits to control the first and second set of stimulation parameters according to the outcome of said comparing of the present and reference states.

19. An adaptive brain stimulation system as in claim 18 in which the sensors sense the present state during a period of active stimulation, during a post-stimulation period, or during a period that can occur in part before and in part after the period of active stimulation.

20. An adaptive brain stimulation systems as in claim 18 in which the sensors are implanted internally within the patient.

21. An adaptive brain stimulation system as in claim 18 wherein said reference state is selected to be a previous state of the patient, a weighted sum of previous states, a population normative value in a normal state, a stimulation “

on”

state, a stimulation “

off”

state, or under the influence of a pharmacological agent, or a weighted state computed based upon evidence of neuronal damage or other physiological, neuroanatomical, or neuropharmacological characteristics of the patient.

22. An adaptive brain stimulation system as in claim 18 wherein the comparator compares the present state data on a time domain or on a frequency domain, or on a transform of the frequency domain, based upon the reference state data in the same domain, or to a threshold value or to a set of threshold values, said comparison using a set of statistical criteria.

23. An adaptive brain stimulation system as in claim 18 wherein DBS set #1 comprises at least one DBS.

24. An adaptive brain stimulation system as in claim 18 wherein DBS set #1 comprises multiple DBS'"'"'s each independently activated and subsequently independently controlled by different ones of the stimulation parameters.

25. An adaptive brain stimulation system as in claim 18 wherein said stimulation parameters include pulse amplitude, pulse width, onset and offset times, frequency, a burst firing mode or a non-burst firing mode, AM or FM state, DC offset, output current, output voltage, relative polarity, and relative latency.

26. A method of using adaptive brain stimulation in the treatment of brain disorder or dysfunction of a patient comprising:

a. sensing a present state of at least one brain region;

b. 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 state,

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

e. repeating steps a, b, c, and d a number of times.

27. A method of claim 26 further including stimulating a second brain region or a second set of brain regions if the comparison meets selected criteria.

28. A method of using adaptive brain stimulation in the treatment of Parkinson'"'"'s Disease and other movement disorders which comprises:

a. sensing the present state of at least one brain region and/or peripheral region;

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

c. performing a statistical and medically significant comparison between the present state and a reference state;

d. changing said stimulation parameters if the comparison fails to meet selected criteria; and

e. repeating steps a, b, c, and d a number of times.

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

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

31. A method as in claim 28 in which the stimulating comprises at least one of electrical, magnetic, and pharmacological stimulation.

32. A method of claim 28 including the step of providing positive reinforcement by stimulating at least a second brain region if the comparison succeeds in meeting the criteria.

33. A method according to claim 28, wherein conditional parameters cause said stimulating to be applied continuously, intermittently as needed, or periodically.

34. A method according to claim 28, wherein the brain disorder or disfunction is at least one of impaired cognitive function, chronic pain, neuropathic pain, seizure, deficits of attention or intention or working memory or awareness, alzheimer'"'"'s disease, dimentia, psychosis, schizophrenia, drug induced psychosis or other drug induced abnormal state, an anxiety disorder, depression or other mood disorder, or is due to a brain injury produced by stroke, blunt head trauma, missile penetration, neurotoxicological agents, virus, anoxia, ischemia, nutritional deficiencies, developmental diseases, degenerative diseases, infectious diseases or complications thereof, or an abnormal brain status due to or causing drug addiction or alcoholism.

35. An adaptive brain stimulation process of treating a patient comprising:

a. stimulating a first brain region or a first set of brain regions of the patient according to a set of stimulation parameters;

b. sensing a present state of the patient;

c. comparing data related to the sensed present state of the patient to data related to a reference state to derive comparison results;

d. determining whether to make a change in the stimulation parameters and, if so, what change, depending on the comparison results;

e. making any changes in the stimulation parameters determined in the preceding step d; and

f. repeating steps a, b, c, d, and e a number of times.

36. A process as in claim 35 including stimulating a second brain region or a second set of brain regions of the patient depending on the comparison results.

37. A process as in claim 36 in which the stimulating of a second brain region or a second set of brain regions comprises causing a positive reinforcement.

38. A process as in claim 35 in which the step of sensing a present state of the patient comprises sensing a state of one or more peripheral regions of the patient'"'"'s body.

39. A process as in claim 38 in which the step of sensing comprises sensing Parkinson'"'"'s tremor.

40. A process as in claim 38 in which the step of sensing comprises sensing one or more movement disorders.

41. A process as in claim 35 in the step of making changes in the stimulation parameters comprises one or more of a multiple DBS iterative (MDBSI) process, a single DBS iterative (SDBSI) process, and a paired DBS iterative (PDBSI) process.

42. A process as in claim 35 in which the step of making changes in the stimulation parameters comprises selecting stimulation parameters from a set of stored parameters used in previous stimulating steps and determined in previous comparing steps to produce desirable results.

43. An adaptive brain stimulation process of treating a brain disorder or dysfunction of a patient comprising:

a. sensing a first present state of the patient;

b. comparing data of the sensed present state of the patient to data from a reference state to derive comparison results;

c. repeating steps a and b, after a specified delay, if said comparison results meet a specified criteria and performing steps d, e, f, g, h and i if said comparison results fail to meet said specified criteria;

d. stimulating a first brain region or a first set of brain regions of the patient according to a set of stimulation parameters;

e. sensing a second present state of the patient;

f. comparing data related to the sensed second present state of the patient to data related to a reference state to derive comparison results;

g. determining whether to make a change in the stimulation parameters and, if so, what change, depending on the comparison results;

h. making any changes in the stimulation parameters determined in the preceding step g; and

i. repeating steps a, b, and c a specified number of times.

44. An adaptive brain stimulation process of treating a brain disorder or dysfunction of a patient comprising:

a. setting a specific value for at least one stimulation parameter and stimulating at least one brain region or set of brain regions

b. sensing a first present state of the patient;

c. comparing said sensed first present state of the patient to data from a reference state to derive a comparison result score;

d. augmenting or decrementing the value of said at least one stimulation parameter

e. repeating steps a, b, c, and d a specified number of times to obtain a set of comparison result scores

f. setting said at least one stimulation parameter to said value that resulted in the lowest comparison result score of said set of comparison result scores

g. sensing a specified number of times to obtain a number of discrete samples of a second present state

h. comparing each of said discrete samples of a second present state or the mean of said discrete samples of a said present state to a reference state in order to obtain a success score, and performing step i if said success score fails to meet a specified criteria and repeating steps g and h if said success score succeeds in meeting said specified criteria.

i. repeating steps a, b, c, d, e, f, g and h.

45. An adaptive brain stimulation process of treating a brain disorder or dysfunction of a patient as described in claim 44, wherein step a comprises setting a specific value for at least one stimulation parameter to affect at least one pair of neurostimulation leads.

46. An adaptive brain stimulation process of treating a brain disorder or dysfunction of a patient as described in claim 44, wherein step f comprises comparing all the said result scores, and in the case where two or more result scores are within a specified proximity to each other, the stimulation parameter that resulted in the lowest amount of a specified stimulation parameter is selected.

47. An adaptive brain stimulation process of treating a brain disorder or dysfunction of a patient as described in claim 44, where step h comprises comparing each of said discrete samples of a second present state or the mean of said discrete samples of a said present state to a reference state in order to obtain a success score, and if said success score fails to meet a specified criteria, entails referencing a database and replacing at least one value of a stimulation parameter with a value that was selected in the past due to producing a desired result score, and repeating steps g and h prior to accomplishing step i.

48. A method of using adaptive brain stimulation for treating a patient using the paired DBS iterative (PDBSI) process comprising:

a. stimulating a first brain region or a first set of brain regions of the patient according to a set of stimulation parameters;

b. sensing a present state of the patient;

c. comparing data related to the sensed present state of the patient to data related to a reference state to derive comparison results;

d. determining whether to make a change in at least one of said stimulation parameters for two stimulation electrodes and, if so, what change, depending on the comparison results;

e. making any changes in the stimulation parameters determined in the preceding step d; and

f. waiting a specified amount of time and then repeating steps a, b, c, d and e for a specified number of times

g. adjusting the stimulation parameters to the settings which produced the lowest said comparison results or the highest said comparison results

h. repeating steps a, b, c, and h, while said comparison results of step c succeed in meeting some specified criteria and if said comparison results fail to meet said specified criteria, repeating steps a, b, c, d, e, f, g and h.

49. An adaptive brain stimulation process of treating a patient comprising as described in claim 48, wherein step b comprises sensing a present state data of the patient and performing signal analysis on said data and if said signal analysis indicates that said patient is sleeping, and if sleeping has been defined as a conditional criteria, then waiting a specified delay and performing step b again.