Systems and methods of individualized magnetic stimulation therapy

• US 10,471,271 B1
• Filed: 02/06/2019
• Issued: 11/12/2019
• Est. Priority Date: 01/21/2005
• Status: Active Grant

• Current Assignee: Michael Sasha John
• Original Assignee: Michael Sasha John
• Inventors: John, Michael Sasha
• Primary Examiner(s): Cox, Thaddeus B
• Application Number:
  US16/269,037
• Time in Patent Office: 279 Days
• 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 treatment of medical disorders use stimulation parameters that provide stimulation of a target site directly or create partial stimulation signals that combine into vector signals that stimulate a target site. Stimulation signals have characteristics such as frequency, timing, temporal content that is adjusted for the person being treated. Signals are designed with advantageous characteristics to influence target tissue in an intended manner and avoid producing unwanted side-effects. Stimulation signals are designed to match or avoid internal/endogenous activity (e.g., brain patterns and rhythms) of a patient. Methods for choosing, creating and partial signals are disclosed. Tissue modulation may be accomplished with electrical and/or magnetic stimulation, such as repetitive transcranial magnetic stimulation.

Claims

1. A system for providing neuromodulation to a patient using transcranial magnetic stimulation based at least partially on brain activity of the patient, the system comprising:

a. a stimulation subsystem having at least one magnetic stimulator that generates a magnetic stimulation signal according to at least one stimulation protocol parameter of a set of stimulation protocol parameters; and

,

b. a control subsystem electrically connected to the stimulation subsystem operating under control of a processor and configured for setting at least one stimulation protocol parameter used by said stimulation subsystem, the control subsystem configured to selectively adjust the at least one stimulation protocol parameter according to a characteristic that is selected from at least one of the group of;

a characteristic of an intrinsic frequency of brain activity selected within a single specified electroencephalogram (EEG) band of the patient;

a characteristic of a peak frequency within a single selected EEG band of the patient;

a spectral profile of a single selected EEG band; and

combinations thereof.

2. The system of claim 1, wherein the spectral profile of a single selected EEG band includes a coherence measure.

3. The system of claim 1, wherein the control subsystem is further configured to selectively adjust the at least one stimulation protocol parameter according to a characteristic of sensed evoked potential data.

4. The system of claim 1, wherein the control subsystem is further configured to selectively adjust the at least one stimulation protocol parameter according to a characteristic of blood-flow sensed by at least one infrared spectroscopy sensor.

5. The system of claim 1, wherein the at least one stimulation protocol parameter controls at least one of the timing, rate, or pattern of a repetitive transcranial magnetic stimulation signal.

6. The system of claim 1, wherein the at least one stimulation protocol parameter is set at a rate to match an intrinsic frequency of a selected EEG band.

7. The system of claim 1, wherein the at least one stimulation protocol parameter is set at a rate which is different than, and offset from, an intrinsic frequency of said single selected EEG band, to entrain the intrinsic frequency at the different rate.

8. The system of claim 1, wherein the characteristic of a peak frequency within the single selected EEG band of the patient is the peak frequency of at least one of an alpha band and a theta band.

9. The system of claim 1, wherein the single selected EEG band is a selected band from at least one of the group of:

about 1 Hz to about 100 Hz, about 0.5 Hz to about 20 Hz, and about 40 Hz to about 100 Hz.

10. The system of claim 1, wherein the single selected EEG band is a selected band from at least one of the group of:

a delta band, a theta band, an alpha band, a beta band, and a gamma band.

11. The system of claim 1, wherein the single selected EEG band has been shown in a reference population to be associated with treatment of a symptom related to at least one of the following:

depression, anxiety, a psychiatric disorder, a cognitive disorder, Parkinson'"'"'s disease, epilepsy, migraine, and a post-traumatic stress disorder.

12. The system of claim 1, further including a sensing subsystem configured to sense data from the patient to obtain sensed data and an evaluation subsystem configured to evaluate the sensed data, the sensing subsystem and evaluation subsystem configured to be controlled by the control subsystem operating under control of the processor, the control subsystem further configured for setting at least one stimulation protocol parameter contingently upon at least one measure derived from the evaluation of the sensed data, the at least one measure selected from the group of:

a characteristic of a peak frequency within the single specified EEG band of the patient, and a characteristic of blood-flow sensed by at least one infrared spectroscopy sensor.

13. The system of claim 12, wherein the sensed data is sensed prior to a stimulation treatment being provided.

14. The system of claim 12, wherein the sensed data is sensed between one or more pulses of the magnetic stimulation signal.

15. The system of claim 12, wherein the sensed data is sensed subsequent to a stimulation treatment being provided.

16. The system of claim 1, wherein the magnetic stimulation signal includes a higher frequency pulse pattern that is modulated by a lower frequency contour to create a repetitive pulsing signal.

17. The system of claim 16, wherein the higher frequency pulse pattern is between 40 and 100 Hz and the lower frequency contour is between 8 and 12 Hz.

18. A method of providing neuromodulation to a patient using transcranial magnetic stimulation applied to the head of the patient using a stimulation signal based at least partially on brain activity of the patient comprising:

a. establishing a stimulation subsystem having at least one magnetic coil stimulator for generating a magnetic stimulation signal according to at least one of a set of stimulation protocol parameters; and

,

b. establishing a control subsystem connected to the stimulation subsystem and a processor;

c. operating the control subsystem under control of the processor;

d. configuring the control subsystem for setting at least one stimulation protocol parameter for use by said stimulation subsystem;

e. configuring the control subsystem for selectively adjusting the at least one stimulation protocol parameter based upon at least one measure of sensed data obtained from the patient, said measure selected from at least one of the group of;

a characteristic of an intrinsic frequency of brain activity of the patient selected within a single selected electroencephalogram (EEG) band of the patient;

a characteristic of a peak frequency within a single selected EEG band of the patient;

a spectral profile of a single selected EEG band of the patient; and

combinations thereof; and

,

f. applying the stimulation signal to the patient for providing neuromodulation to the patient.

19. The method of claim 18, wherein the stimulation protocol parameter controls at least one of the timing, rate, or pattern of a repetitive transcranial magnetic stimulation signal.

20. The method of claim 18, wherein the at least one stimulation protocol parameter is set at a rate that is set to match an intrinsic frequency of a selected EEG band.