# US 11,027,127 B2 · Devices and methods for treating medical disorders with evoked potentials and vagus nerve stimulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,027,127 B2 - Document ID: US11027127B2 - Status: Granted - Kind: B2 - Application number: 16/511,953 - Filed: 2019-07-15 - Published: 2019-11-07 - Granted: 2021-06-08 - Earliest claimed: 2013-04-28 - Assignees: ElectroCore, Inc. - Applicants: ElectroCore, Inc. - Inventors: Bruce J. Simon; Joseph P. Errico - Web page: https://patentgrep.com/patent/US11027127B2 ## CPC - A61N 1/36021: {for treatment of pain} - A61B 5/394: specially adapted for electroglottography or electropalatography - A61B 5/4035: {Evaluating the autonomic nervous system} - A61B 5/4041: {Evaluating nerves condition} - A61B 5/4803: {Speech analysis specially adapted for diagnostic purposes} - A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)} - A61B 5/7264: {Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems} - A61B 5/7267: {involving training the classification device} - A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]} - A61N 1/36031: {using physiological parameters for adjustment} - A61N 1/36034: {specified by the stimulation parameters} - A61B 5/02405: {Determining heart rate variability} - A61B 2090/3941: {Photoluminescent markers} - A61N 1/40: Applying electric fields by inductive or capacitive coupling (microwave apparatus A61N5/00); {Applying radio-frequency signals} - G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems - G16H 50/70: for mining of medical data, e.g. analysing previous cases of other patients - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA ## 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 ### Claim 1 A method comprising: applying a first sensory stimulus to a patient having a medical condition; measuring a first baseline evoked potential from the patient, wherein the first baseline evoked potential is evoked by the first sensory stimulus; applying a treatment for a medical condition to the patient; applying a second sensory stimulus to the patient after the treatment; measuring an acute response of the patient to the medical condition as a function of a characteristic of the treatment, wherein the acute response comprises a second evoked potential evoked by the second sensory stimulus; and comparing the acute response to the first baseline evoked potential to determine whether the patient is a responder to the treatment. ### Claim 2 (depends on 1) The method of claim 1, wherein the sensory stimulus comprises at least one of a visual, auditory, somatosensory, painful, olfactory, gustatory, vestibular, or interoceptive stimulus. ### Claim 3 (depends on 1) The method of claim 1, wherein the treatment comprises a vagus nerve stimulation. ### Claim 4 (depends on 1) The method of claim 1, wherein the treatment comprises applying an electrical impulse transcutaneously through an outer skin surface of a neck of the patient to a vagus nerve of the patient. ### Claim 5 (depends on 4) The method of claim 4, further comprising: varying a plurality of different parameters of the treatment based on comparing the acute response to the first baseline evoked potential to determine whether the patient is a responder to the different parameters. ### Claim 6 (depends on 5) The method of claim 5, wherein the different parameters comprise at least one of an amplitude or a frequency of the electrical impulse. ### Claim 7 (depends on 5) The method of claim 5, wherein the different parameters comprise applying the electrical impulse to a different location on the neck of the patient. ### Claim 8 (depends on 5) The method of claim 5, wherein the different parameters comprise applying the electrical impulse via a different orientation on the neck of the patient. ### Claim 9 (depends on 1) The method of claim 1, wherein the medical condition comprises a primary headache. ### Claim 10 (depends on 1) The method of claim 1, wherein the acute response comprises a reduction in pain of the patient. ### Claim 11 (depends on 1) The method of claim 1, wherein the patient exhibits a reduction in magnitude of the second evoked potential compared to the first evoked potential. ### Claim 12 (depends on 1) The method of claim 1, wherein the patient exhibits an increase in magnitude of the second evoked potential compared to the first evoked potential. ### Claim 13 A method comprising: applying a sensory stimulus to a patient having a medical condition; 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 treatment paradigm comprising an application of the electrical impulse in multiple doses per day for a period of time greater than 1 day and less than 3 months; measuring a second baseline evoked potential from the patient as a function of a characteristic of the treatment; and comparing the second baseline evoked potential to the first baseline evoked potential to determine whether the patient is a responder to the treatment. ### Claim 14 (depends on 13) The method of claim 13, wherein the sensory stimulus comprises at least one of a visual, auditory, somatosensory, painful, olfactory, gustatory, vestibular, or interoceptive stimulus. ### Claim 15 (depends on 13) The method of claim 13, wherein the medical condition comprises a primary headache. ### Claim 16 (depends on 13) The method of claim 13, wherein the second baseline evoked potential is measured after the treatment paradigm has been completed. ### Claim 17 (depends on 16) The method of claim 16, wherein the second baseline evoked potential comprises a reduction in pain of the patient. ### Claim 18 (depends on 16) The method of claim 16, wherein the second baseline evoked potential comprises a reduction in a number of headache days of the patient. ### Claim 19 (depends on 13) The method of claim 13, wherein the patient exhibits a deficit with regard to a habituation of the evoked potential. ### Claim 20 (depends on 13) The method of claim 13, wherein the treatment increases a habituation of the second evoked potential. ### Claim 21 (depends on 13) The method of claim 13, 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.