SYSTEMS AND METHODS FOR STIMULATING AND/OR MONITORING LOCI IN THE BRAIN TO TREAT INFLAMMATION AND TO ENHANCE VAGUS NERVE STIMULATION

• US 20160114165A1
• Filed: 10/23/2015
• Published: 04/28/2016
• Est. Priority Date: 10/24/2014
• Status: Active Grant

• Current Assignee: Setpoint Medical Corporation
• Original Assignee: Jacob A. Levine, Mike A Faltys
• Inventors: LEVINE, Jacob A., FALTYS, Michael A.
• Granted Patent: US 11,311,725 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/377 using evoked responses
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3758 Packaging of the components within the casing
• CPC Class Codes: A61N 1/3787 from an external energy source
• 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

Described herein are methods and systems for using EEG recordings to improve vagus nerve stimulation (VNS) therapy. In particular, described herein are methods and systems for using EEG recordings to detect P300 and/or activation of the nucleus basalis and/or the locus coeruleus to determine the efficacy of VNS. The EEG recordings can be used to provide feedback control to help optimize stimulation parameters and to screen for patients that respond well to VNS therapy.

Claims

1. A method for inducing long term potentiation of the inflammatory reflex in a patient, the method comprising:

stimulating the vagus nerve of the patient according to a set of stimulation parameters;

recording an EEG after the step of stimulating the vagus nerve;

determining from the recorded EEG whether at least one of the nucleus basalis and the locus coeruleus has been activated by the vagus nerve stimulation; and

adjusting the set of stimulation parameters based on the determination from the recorded EEG whether at least one of the nucleus basalis and the locus coeruleus has been activated.

2. The method of claim 1, wherein the step of adjusting the set of stimulation parameters comprises increasing a stimulation amplitude.

3. The method of claim 1, further comprising recording a baseline EEG.

4. The method of claim 3, wherein the step of determining from the recorded EEG whether at least one of the nucleus basalis and the locus coeruleus has been activated by the vagus nerve stimulation comprises comparing the recorded EEG with the baseline EEG.

5. A method for inducing long term potentiation of the inflammatory reflex in a patient, the method comprising:

stimulating the vagus nerve according to a set of stimulation parameters sufficient for activating at least one of the nucleus basalis and the locus coeruleus.

6. The method of claim 5, wherein the set of stimulation parameters comprises an amplitude between about 0.1 and 3 mA, a frequency between about 1 Hz and 30 Hz, a pulse width between about 100 uS and 500 uS, and a duration between about 0.5 second to 10 minutes.

7. A method for prescreening a patient, the method comprising:

noninvasively stimulating the vagus nerve;

recording an EEG; and

determining whether the patient will be responsive to an invasive vagus nerve stimulation based on an analysis of the EEG.

8. The method of claim 7, wherein the step of determining whether the patient will be responsive to an invasive vagus nerve stimulation based on an analysis of the EEG comprises determining whether P300 is present in the EEG.

9. The method of claim 7, wherein the step of determining whether the patient will be responsive to an invasive vagus nerve stimulation based on an analysis of the EEG comprises determining with the EEG whether at least one of the nucleus basalis and the locus coeruleus was activated by the noninvasive vagus nerve stimulation.

10. The method of claim 7, wherein the step of noninvasively stimulating the vagus nerve comprises noninvasively stimulating the auricular branch of the vagus nerve.

11. The method of claim 10, wherein the noninvasive stimulation of the auricular branch of the vagus nerve is electrical.

12. The method of claim 10, wherein the noninvasive stimulation of the auricular branch of the vagus nerve is mechanical.

13. The method of claim 7, wherein the step of recording the ECG takes place after the step of noninvasively stimulating the vagus nerve.

14. The method of claim 7, wherein the step of recording the ECG takes place during the step of noninvasively stimulating the vagus nerve.

15. A method for providing feedback control during vagus nerve stimulation of a patient, the method comprising:

stimulating the vagus nerve with a vagus nerve stimulator;

recording an EEG to detect at least one of P300, activation of the nucleus basilis, and activation of the locus coeruleus; and

adjusting an amplitude of the stimulation to the vagus nerve until at least one of P300, activation of the nucleus basilis, and activation of the locus coeruleus is detected in the EEG.

16. The method of claim 15, further comprising programming the vagus nerve stimulator with a set of stimulation parameters based on the step of adjusting the amplitude of the stimulation to the vagus nerve until at least one of P300, activation of the nucleus basilis, and activation of the locus coeruleus is detected in the EEG.

17. The method of claim 15, wherein the step of adjusting the amplitude comprises increasing the amplitude when the patient is not responding to the stimulation of the vagus nerve.

18. The method of claim 15, wherein the step of adjusting the amplitude comprises decreasing the amplitude when the patient is responding well to the stimulation of the vagus nerve.

19. The method of claim 15, further comprising increasing a stimulation interval after the step of adjusting the amplitude of the stimulation to the vagus nerve until at least one of P300, activation of the nucleus basilis, and activation of the locus coeruleus is detected in the EEG.

20. A system for stimulating a nerve of a patient, the system comprising:

an implantable nerve stimulator configured to stimulate the nerve of the patient according to a set of programmed stimulation parameters;

an EEG recording device configured to record an EEG of the patient; and

a controller in communication with both the EEG recording device and the implantable nerve stimulator, the controller programmed to determine whether at least one of P300, activation of the nucleus basalis, and activation of the locus coeruleus is indicated by the EEG, and adjust the set of programmed stimulation parameters based on the determination of whether at least one of P300, activation of the nucleus basalis, and activation of the locus coeruleus is indicated by the EEG.

21. The system of claim 20, wherein the controller is located in a prescription pad.

22. The system of claim 20, wherein the controller is located in an energizer configured to provide power to the implantable nerve stimulator.

23. The system of claim 20, wherein the controller is located in the EEG recording device.

24. The system of claim 20, wherein the set of programmed stimulation parameters comprises a pulse amplitude, a pulse width, and a pulse frequency.

25. A method for treating a patient suffering from inflammation, the method comprising:

stimulating at least one of the nucleus basalis and the locus coeruleus with an electrode implanted within the patient'"'"'s brain; and

reducing a level of inflammation in the patient.

26. The method of claim 25, wherein the step of stimulating at least one of the nucleus basalis and the locus coeruleus with an electrode implanted within the patient'"'"'s brain comprises delivering an electrical stimulus having a current between 10 to 100 uA, a frequency of 1 to 500 Hz, and a duration of up to 120 minutes.

27. A method for treating a patient suffering from inflammation, the method comprising:

stimulating at least one of the nucleus basalis and the locus coeruleus with a focused magnetic field; and

reducing a level of inflammation in the patient.

28. The method of claim 27, wherein the step of stimulating at least one of the nucleus basalis and locus coeruleus with the focused magnetic field comprises generating the focused magnetic field with a transcranial magnetic coil.

29. The method of claim 27, wherein the step of stimulating at least one of the nucleus basalis and locus coeruleus with the focused magnetic field comprises generating the magnetic field with a frequency below 3 Hz, a field strength below 3 Tesla, and a duration between 5 to 60 minutes.

30. The method of claim 27, wherein the step of stimulating at least one of the nucleus basalis and locus coeruleus with the focused magnetic field comprises generating the magnetic field with a frequency between 3 to 25 Hz, a field strength below 3 Tesla, and a duration between 5 to 60 minutes.