Devices and methods for treating medical disorders with evoked potentials and vagus nerve stimulation

• US 9,427,581 B2
• Filed: 03/14/2014
• Issued: 08/30/2016
• Est. Priority Date: 04/28/2013
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J., Errico, Joseph P.
• Primary Examiner(s): Patton, Amanda
• Assistant Examiner(s): EDWARDS, PHILIP CHARLES
• Application Number:
  US14/212,992
• Publication Number:
  US 20140324118A1
• Time in Patent Office: 900 Days
• Field of Search: 607/46
• US Class Current: 1/1
• CPC Class Codes: A61B 2090/3941 Photoluminescent markers
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/394 specially adapted for electroglottography or electropalatography
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4803 Speech analysis specially adapted for diagnostic purposes
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 5/7267 involving training the classification device
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients

Abstract

Devices, systems and methods for treating medical disorders, such as migraine or other primary headaches, or fibromyalgia, by noninvasive electrical stimulation of a vagus nerve, used in conjunction with the measurement of evoked potentials (EPs). The system comprises a stimulator that is applied to the surface of the patient'"'"'s neck to apply electrical impulses sufficient to stimulate a cervical vagus nerve, scalp electrodes that are used to measure EPs that are evoked by that stimulation, feedback or biofeedback circuits to vary the stimulation based upon EP characteristics, and other sensory stimulation modalities that produce EPs. The system is preferably used to optimize the placement of the stimulator, to test whether a patient is a suitable candidate for treatment using vagus nerve stimulation, and to select the stimulation parameters that optimized acute or chronic treatment, e.g., by correcting an EP habituation deficit.

Claims

1. A method for determining whether a patient is a responder to a medical therapy, the method comprising:

applying a sensory stimulus to a patient;

measuring a first baseline evoked potential from the patient, wherein the first baseline evoked potential is evoked by the sensory stimulus;

applying a treatment for the medical condition to the patient;

comparing a result of the treatment to a characteristic of the first baseline evoked potential to determine whether the patient is a responder to the treatment;

measuring a second evoked potential from the patient subsequent to the treatment; and

comparing a characteristic of the first baseline evoked potential and a characteristic of the second evoked potential to determine whether the patient is a responder to the treatment, wherein the treatment increases a habituation of the second evoked potential.

2. The method of claim 1 wherein the stimulus comprises a visual, auditory, somatosensory, painful, olfactory, gustatory, vestibular, or interoceptive stimulus.

3. The method of claim 1 wherein the treatment comprises vagus nerve stimulation.

4. The method of claim 1 wherein the treatment comprises applying one or more electrical impulses transcutaneously through an outer skin surface of a neck of the patient to a vagus nerve of the patient.

5. The method of claim 1 wherein the patient exhibits a deficit with regard to habituation of the evoked potential.

6. A method for determining whether a patient is a responder to a medical therapy, the method comprising:

applying a sensory stimulus to a patient;

measuring a first baseline evoked potential from the patient, wherein the first baseline evoked potential is evoked by the sensory stimulus;

applying a treatment for the medical condition to the patient, wherein the treatment comprises a vagus nerve stimulation via a device;

comparing a result of the treatment to a characteristic of the first baseline evoked potential to determine whether the patient is a responder to the treatment;

measuring a second evoked potential from the patient subsequent to the treatment; and

comparing a characteristic of the first baseline evoked potential and a characteristic of the second evoked potential to determine whether the patient is a responder to the treatment, wherein the treatment increases a habituation of the second evoked potential.

7. The method of claim 6, wherein the sensory stimulus comprises at least one of a visual, auditory, somatosensory, painful, olfactory, gustatory, vestibular, or interoceptive stimulus.

8. The method of claim 6, wherein the treatment comprises an application of an electrical impulse transcutaneously through an outer skin surface of a neck of the patient to a vagus nerve of the patient.

9. The method of claim 6, wherein the patient exhibits a deficit with regard to a habituation of the evoked potential.

10. A method for determining whether a patient is a responder to a medical therapy, the method comprising:

applying a sensory stimulus to a patient;

measuring a first baseline evoked potential from the patient, wherein the first baseline evoked potential is evoked by the sensory stimulus;

applying a treatment for the medical condition to the patient, wherein the treatment comprises an application of an electrical impulse transcutaneously via a device through an outer skin surface of a neck of the patient to a vagus nerve of the patient;

comparing a result of the treatment to a characteristic of the first baseline evoked potential to determine whether the patient is a responder to the treatment;

measuring a second evoked potential from the patient subsequent to the treatment; and

comparing a characteristic of the first baseline evoked potential and a characteristic of the second evoked potential to determine whether the patient is a responder to the treatment, wherein the treatment increases a habituation of the second evoked potential.

11. The method of claim 10, wherein the sensory stimulus comprises at least one of a visual, auditory, somatosensory, painful, olfactory, gustatory, vestibular, or interoceptive stimulus.

12. The method of claim 10, wherein the treatment comprises a vagus nerve stimulation.

13. The method of claim 10, wherein the patient exhibits a deficit with regard to a habituation of the evoked potential.