Multiple-symptom medical treatment with roving-based neurostimulation.

• US 20070142874A1
• Filed: 01/23/2007
• Published: 06/21/2007
• Est. Priority Date: 01/21/2005
• Status: Active Grant

• Current Assignee: Michael John
• Original Assignee: Michael John
• Inventors: John, Michael
• Granted Patent: US 8,825,166 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence

Abstract

Stimulation treatments for various medical disorders comprise serially varying the stimulation parameters, especially in order to treat multiple symptoms of a disorder. Roving of parameter values can be done in relation to the proportional incidence of the symptoms. Varying the parameters can occur according to algorithms designed in relation to endogenous rhythms of a patient. Especially when using low-frequency stimulation signals the parameter values can be set in order to match or avoid these internal activity patterns and rhythms. These treatment strategies thereby improve the therapeutic efficacy of stimulation or and decrease risk of interference with normal brain, sensory, motor, and cognitive processes. Novel methods are described for choosing, creating and subsequently stimulating with partial signals having unique temporal and spectral profiles which summate to produce desired vector fields, and which may be roved to produce roving vector fields. Stimulation can occur using different devices such as implantable devices or transcranial magnetic stimulators.

Claims

1. A device for treating a disorder of the central nervous system comprising:

a conduit set containing at least one stimulation conduit;

a stimulation subsystem for providing stimulation to probes according to a treatment protocol having at least one treatment parameter value;

a control subsystem for controlling the stimulation subsystem, the control subsystem having at least 2 candidate treatment protocols;

said control subsystem operating under a treatment program designed for alternating between 2 or more candidate treatment protocols; and

,

wherein each candidate protocol is directed to primarily decrease a particular type of symptom related to the disorder.

2. The device of claim 1 wherein alternating between 2 or more candidate treatment protocols comprises roving between 2 or more parameter values associated with 2 or more stimulation protocols.

3. The device of claim 2 wherein 2 or more stimulation protocol are repeatedly selected approximately sequentially to both provide at least one stimulation signal to stimulate at least a first stimulation conduit.

4. The device of claim 2 wherein a first said stimulation protocol provides at least one stimulation signal to provide stimulation to at least a first stimulation conduit and a second stimulation protocol provides stimulation to at least a second stimulation conduit.

5. The device of claim 1 wherein the disorder of the central nervous system is epilepsy and said particular type of symptom is related to at least one of the type, location, spectral signature, size, and duration of abnormal activity.

6. The device of claim 1, wherein the disorder is a movement disorder and said particular type of symptom is related to the type, location, size, and duration of a movement disorder symptom.

7. The device of claim 1, wherein the disorder is pain and said particular type symptom is a related to the type, location, size, and duration of pain symptom.

8. The device of claim 2 wherein said alternating between 2 or more stimulation protocols comprises adjusting at least one parameter value of the stimulation protocol between 2 or more values.

9. The device of claim 2, wherein roving between 2 or more stimulation protocols occurs according to an algorithm that is programmed so that the duration of time stimulating with each of 2 or more stimulation signals is correlated with the proportion of the incidence of two or more symptoms.

10. The device of claim 2, wherein roving between 2 or more stimulation protocols consists of selecting protocols each configured to stimulate with sine wave of a unique frequency.

11. The device of claim 2, wherein roving between 2 or more stimulation protocols consists of selecting stimulation protocols each configured to stimulate with a unique stimulation signal having a spectral profile between approximately 0.5 Hz and 20 Hz, said profile being uniquely defined so that the signals defined by said 2 or more stimulation protocols approximately do not overlap in their spectral content.

12. The device of claim 2, wherein roving between 2 or more candidate stimulation protocols comprises stimulating with at least two stimulation signals each having amplitudes selected to primarily stimulate at least one particular conduit of the conduit set.

13. A method of claim 2 wherein each of said 2 or more candidate stimulation protocols primarily deters a specific pattern of activity, associated with the disorder.

14. A method of claim 2 wherein each of said 2 or more candidate stimulation protocols primarily enhances a specific type of activity, associated with treatment of the disorder.

15. The device of claim 1, which additionally includes:

a sensor set including at least one sensor

a sensing subsystem for sensing data from the sensor to obtain sensed data,

a control subsystem operating under the treatment program that is further configured for controlling the sensing subsystem and for providing processing of said sensed data in order to obtain at least one sensed data result, and adjusting one or more parameters of one or more candidate treatment protocols according to this result.

16. The method of claim 15, wherein alternating between 2 or more candidate treatment protocols, occurs according to an algorithm so that the proportion of time stimulating with each of 2 or more stimulation signals of the treatment protocols is correlated with the proportion of incidence of two or more symptoms, as calculated from the results of processing of said sensed data.

17. The device of claim 16, wherein the parameter values of the 2 or more candidate treatment protocols are chosen according to at least two seizure types which are detected within or predicted from said results of processing of said sensed data.

18. The device of claim 16, wherein the parameter values of the 2 or more candidate treatment protocols are chosen as values shown to produce test scores above a threshold criteria.

19. A device of claim 16, wherein the test score is a tremor score which is computed from a symptom including at least one of the count, duration, size, and type of a tremor.

20. A device of claim 16, wherein the test score is at least one seizure score which is computed from at least one of the count, duration, size, and type of seizures or seizure related activities.

21. The device of claim 16, wherein the alternating between 2 or more candidate treatment protocols occurs according to a ‘

rate of alternating’

parameter that is modified according sensed data features.

22. The device of claim 16, wherein the adjusting one or more parameters of the treatment protocols is a delay parameter which is adjusted so that the stimulation signal is provided approximately out-of-phase with endogenous activity and adds primarily or destructively with endogenous activity.

23. A method of treating a brain disorder comprising:

selecting a stimulation program designed to provide stimulating with at least one stimulation signal, said stimulation program having a stimulation parameter which defines a characteristic of the stimulation signal;

said stimulation program further designed for roving said stimulation parameter over a selected range comprising a minimum value and a maximum value; and

,

operating an implanted device to implement said stimulation program to provide modulation of tissue of a patient in an intended manner.

24. The method of claim 23 wherein the stimulation parameter defines the center frequency of the stimulation signal.

25. The method of claim 24, wherein the centre frequency is the center bandwidth of a band-limited stimulation signal.

26. The method of claim 23, wherein roving occurs so that the time spent stimulating at different stimulation parameter values is proportionate to the incidence of each of two or more type of symptoms.

27. The method of claim 23, wherein said roving comprises discretely alternating between at least two stimulation parameter values each of which have been previously found to produce therapeutic benefit.

28. The method of claim 23, wherein said roving is related to a frequency of the stimulation signal, and wherein said roving occurs according to a roving function, said roving function being defined to avoid values that would cause the frequency of the stimulation signal to approximately match a range frequencies related to the endogenous activity of a patient.

29. The method of claim 23, wherein roving occurs so that the time spent stimulating at different parameter values within the range is a function of the proportion of the incidence of the two or more type of symptoms, wherein the symptoms are types of seizures.

30. The method of claim 23 wherein the disorder is related to at least one of pain, depression, and a movement disorder.

31. The method of claim 23, wherein the roving occurs according to roving parameters, said roving parameters including a rate of roving parameter value that determines the modulation rate of a carrier signal, where the modulation rate defined as a function which is at least one of:

linear, exponential, and, a user-defined function.

32. The method of claim 23, wherein said roving includes one of:

a. Maintaining the modulation rate while the spectral content of the carrier signal is roved;

b. Maintaining the modulation rate while the band-width of the spectral content of the carrier signal is roved; and

,

c. Maintaining the spectral content of the carrier signal while the modulation rate is roved.

33. The method of claim 23 wherein said roving occurs to produce an improvement in at least on of the following:

neural entrainment;

attenuation of adaptation to the stimulation;

energy transmission to a target site; and

, the emergence of unwanted side-effects.

34. The method of claim 23, wherein said range has been found to include at least one value which deters a specific pattern of activity, associated with the disorder.

35. The method of claim 23 wherein the starting value and final value are selected to include at least two values which have been shown to be therapeutic.

36. A method of treating a disorder comprising:

Operating an implanted device using a treatment program that causes roving between 2 or more candidate stimulation protocols,

wherein a first candidate stimulation protocol provides a first therapeutic benefit and a second candidate stimulation protocol provides a second therapeutic benefit; and

,

said first and second therapeutic benefits are at least partially independent.

37. The method of claim 36 wherein each said therapeutic benefit is primarily related to deterring a particular type of symptom related to a disorder.

38. The method of claim 37, wherein the disorder is epilepsy and said particular type of symptom is a related to the type, location, size, and duration of epileptiform activity.

39. The method of claim 37, wherein the disorder is depression and said particular type of symptom is a related to at least one of the following:

anhedonia;

indifference;

apathy;

labile emotions;

sad mood;

low energy;

poor concentration;

decreased amount of sleep or appetite;

irritability;

feelings of worthlessness or hopelessness; and

, thoughts of suicide.

40. The method of claim 37, wherein the disorder is a movement disorder and said particular type of symptom is a related to at least one of the following:

rigidity;

tremor;

primary functional deficits and negative symptoms;

hypokinesia;

bradykinesia;

paucity of movement;

slowness of movement;

paralysis;

apraxia;

disorders of postural fixation;

weakness;

defects in proprioception or labyrinthine function;

secondarv release phenomena and positive symptoms;

chorea;

athetosis;

mood disturbances;

cognitive disturbances;

sensation disturbances;

autonomic disturbances; and

, dystonia.

41. The method of claim 37, wherein the disorder is a pain disorder and said particular type of symptom is a related to at least one of the following:

acute pain;

chronic pain;

a particular type of pain;

a particular region at which pain is experienced;

cutaneous pain;

neuropathic pain;

somatic pain;

visceral pain;

psychological pain;

post-operative chronic pain;

fibromyalgia;

reflex sympathetic dystrophy;

defects in proprioception; and

, dystonia.

42. The method of claim 36, wherein one or more of said stimulation protocols provides stimulation to human tissue which is at least one of the following:

the brain, spinal cord, peripheral nerves, vagus nerves.

43. The method of claim 36, wherein said first candidate stimulation protocol defines two partial signals that are presented using at least 2 conduits that are sufficiently close to each other that said partial signals induce fields in tissue that are at least partially overlapping.

44. A method of claim 36, wherein a first candidate protocol provides stimulation to promote a change chemical levels in target tissue.

45. The method of claim 44 wherein said change causes neural tissue to be more receptive to stimulation provided during a candidate protocol.

46. A device for treating a disorder of the central nervous system comprising:

a conduit set containing at least one stimulation conduit;

a stimulation subsystem for providing stimulation using the stimulation conduit according to a treatment protocol;

a control subsystem for controlling the stimulation subsystem, the control subsystem having at least 2 candidate treatment protocols;

said control subsystem operating under a treatment program designed for alternating between 2 or more candidate treatment protocols; and

,

wherein each candidate protocol that is selected is associated with a test score which is above at least a minimum score threshold.

47. The device of claim 46, wherein the alternating between 2 or more candidate treatment protocols occurs according to a rate of alternating parameter that is selected according to rates that produced test scores above at least a minimum score threshold.

48. The device of claim 46, wherein the 2 or more candidate treatment protocols are selected to have parameter values that are outside of a specified range, said range being selected so that the resulting stimulation signals produced by the treatment protocols do not match spectral characteristics of selected types of endogenous activity of the patient.