DEVICES AND METHODS FOR OPTIMIZED NEUROMODULATION AND THEIR APPLICATION

• US 20170246481A1
• Filed: 02/27/2017
• Published: 08/31/2017
• Est. Priority Date: 11/11/2009
• Status: Abandoned Application

• Current Assignee: David J. Mishelevich
• Original Assignee: David J. Mishelevich
• Inventors: Mishelevich, David J
• Application Number:
  US15/444,268
• Publication Number:
  US 20170246481A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36078 Inducing or controlling sleep or relaxation non-implantable stimulator A61M21/00
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/361 Phantom sensations, e.g. tinnitus
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 2/002 in combination with another treatment
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2/008 for pain treatment or analgesia
• CPC Class Codes: A61N 2007/0021 Neural system treatment
• CPC Class Codes: A61N 2007/0026 Stimulation of nerve tissue
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

Disclosed are methods and systems for optimized deep or superficial deep-brain stimulation using multiple therapeutic modalities impacting one or multiple points in a neural circuit to produce Long-Term Potentiation (LTP) or Long-Term Depression (LTD). Also disclosed are methods for treatment of clinical conditions and obtaining physiological impacts. Also disclosed are: methods and systems for Guided Feedback control of non-invasive deep brain or superficial neuromodulation; patterned neuromodulation, ancillary stimulation, treatment planning, focused shaped or steered ultrasound; methods and systems using intersecting ultrasound beams; non-invasive ultrasound-neuromodulation techniques to control the permeability of the blood-brain barrier; non-invasive neuromodulation of the spinal cord by ultrasound energy; methods and systems for non-invasive neuromodulation using ultrasound for evaluating the feasibility of neuromodulation treatment using non-ultrasound/ultrasound modalities; neuromodulation of the whole head, treatment of multiple conditions, and method and systems for neuromodulation using ultrasound delivered in sessions.

Claims

1. A method for neuromodulation by one or more neuromodulation modalities of one or a plurality of neural targets comprising:

a. providing one or a plurality of neuromodulation transducers;

b. aiming the energy of said ultrasound transducers at one or a plurality of applicable neural targets; and

c. neuromodulating the ultrasound transducers with a control unit using guided-feedback neuromodulation wherein a set of neuromodulation parameters/variables is applied in a given time segment, the patient, operator, or agent judges the result, and based on that feedback result an optimization algorithm is applied to determine the neuromodulation parameters/variables to be applied in the next time segment.

2. The method of claim 1 where the optimization algorithm guiding the neuromodulation is not limited to but generally selected from the group consisting of hill climbing algorithm, the greedy algorithm, and simulated annealing.

3. The method of claim 1 where the result of feedback from neuromodulation due to the algorithmic change in the current time segment providing by the mechanism selected from the group consisted from patient, operator, and physiological sensor is compared to the result of the neuromodulation in the previous time segment where the comparison is selected from the group consisting of better, worse, unchanged, and relative level on a numerical scale and input to the optimization algorithm.

4. The method of claim 1 where the judgments are made on the basis selected from the group consisting of continuous and periodic.

5. The method of claim 4 where the lengths periodic time-segments after which strategy is changed are not limited to but typically will be in the range of 0.5 to 6 minutes.

6. The method of claim 1 where the successful parameters and strategy used in one session are saved and used at the start of the next neuromodulation session.

7. The method of claim 1 where signal derived from guided feedback is recorded and played back at a subsequent time.

8. The method of claim 1 in which a derived signal from the guided feedback is generated representing one or more factors selected from the group consisting the change in neuromodulation parameters, the relative change in symptoms based on input from the group from the consisting of as judged by the patient, as judged by the operator, and one or a plurality of sensors.

9. The method of claim 8 in which the derived signal is applied for the purpose selected from the group consisting of driving ancillary neuromodulation, driving a physical action such as counteracting tremor, operating a bionic limb or other actuator, and driving a display on a computer screen.

10. The method of claim 1 where one or a plurality of neuromodulation-modality specific parameters to be varied are not limited to but are selected as applicable from the group consisting of stimulation frequency, pulse duration, pulse frequency, pulse pattern, intensity, phase, phase-intensity relationships, intensity envelopes, frequency envelopes, sweeps of dynamic transducers, mechanical-perturbation length, mechanical perturbation frequency, and wavelength of light.

11. The method of claim 10 where the order in which changes are to be applied by one with ordinary skill in the art, while not limited to this order, higher priority change to be made as applicable to a given neuromodulation modality is pulse repetition, pulse duty cycle, wavelength, and neuromodulation frequency, changing the shape of the neuromodulation by using mechanical perturbations, and changing the aiming of the energy transducers.

12. The method of claim 3 where the result is indicated by the operator/patient using a mechanism not limited to or selected from mouse, joystick, bars, spinner, voice-command input, and touchscreen.

13. The method of claim 1 where the one or a plurality of neural targets are each neuromodulated by a modality selected from the group consisting of deep brain stimulation, spinal cord stimulation, vagal nerve stimulation, sphenopalatine ganglion stimulation, occipital nerve stimulation, transcranial magnetic stimulation, ultrasound neuromodulation, radiofrequency stimulation, optogenetics, and ancillary stimulation.

14. The method of claim 1 where the clinical condition to be treated or physiological effect is selected from the group consisting of orgasm elicitation, stroke and rehabilitation, pain, tinnitus, depression and bipolar disorder, addiction, Post Traumatic Stress Disorder, motor disorders, Autism Spectrum, obesity, Alzheimer'"'"'s Disease, anxiety including panic disorder, Obsessive Compulsive Disorder, gastrointestinal motility, Tourette'"'"'s Syndrome, schizophrenia, epilepsy, Attention Deficit Hyperactivity Disorder, eating disorders, cognitive enhancement, traumatic brain injury including concussion, compulsive sexual disorders, emotional catharsis, Autonomous Sensory Meridian Response (ASMR), occipital nerve neuromodulation, Sphenopalatine Ganglion neuromodulation, and Reticular Activating System (RAS).

15. The method of claim 14 where the condition-assessment pairs are not limited to but selected from the group consisting of orgasm elicitation-arousal, stroke and stroke rehabilitation-movement of affected area, pain-pain Visual Analog Scale, tinnitus-tinnitus level, depression and bipolar disorder-affect, addiction-craving, post-traumatic stress disorder-reaction to inciting image, motor disorder-tremor magnitude, autism spectrum disorders-reaction to spontaneous situation, obesity-food craving, Alzheimer'"'"'s Disease-performance on memory test, anxiety including panic disorder-response to frenetic images and/or audio, obsessive compulsive disorder-response to video, GI motility-response to food inciting for diarrhea, Tourette'"'"'s Syndrome-response to inciting situation, schizophrenia-response to inciting visual or audio, eating disorders-reaction to food, cognitive enhancement-performance on problem-solving test or video gaming, traumatic brain injury including concussion-ability to perform repetitive physical activity, compulsive sexual disorders-reaction to explicit material, emotional catharsis-reaction to release trigger, autonomous sensory meridian response (ASMR)-reaction to ASMR-eliciting known phenomenon for the given individual, occipital nerve-pain Visual Analog Scale, sphenopalatine ganglion-pain Visual Analog Scale, and reticular activating system-ocular microtremor.

16. The method of claim 15 where an ancillary stimulation such as applying pressure to the point of causing pain is used to facilitate assessment of feedback.

17. The method of claim 8 where instead of patient symptoms or the effect being sought being judged, a surrogate for the symptom or effect is judged.

18. The method of claim 17 where the symptom is chronic pain and the surrogate is acute pain.