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Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain | Clinical Trials | Clareo Health

COMPLETEDNA

Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain

NCT04166045•Theranova, L.L.C.

Summary

Clinical study to determine the responder rate of the TheraNova Migraine Treatment System to that of a sham control treatment.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18-100 years, inclusive
•Diagnosis of episodic migraine with and without aura per International Headache Society diagnostic criteria
•4-14 migraine days per month
•Ability to provide informed consent
•Demonstrates no contraindication to the use of electrical nerve stimulation
•Capable and willing to follow all study-related procedures

Exclusion Criteria

•Currently pregnant or breastfeeding, pregnant within the past 6 months or intends to become pregnant during the enrollment period
•Diagnosis of chronic migraine or other forms of primary or secondary headache disorders, including medication overuse headache per International Headache Society diagnostic criteria
•Any medical condition that would, in the opinion of the investigator, make the subject ineligible
•Has received botulinum toxin injections within the past 3 months
•Is currently implanted with an electrical and/or neurostimulator devic, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, sacral stimulator, bone growth stimulator, or cochlear implant
•Use of investigational drug/device therapy within the past 4 weeks
•Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination (including bleeding disorders, anticoagulant medications and peripheral neuropathy)
•No changes in preventive medications (or other medications determined to potentially interfere with the study) in the previous 30 days and no intent to change it during the study

Locations (1)

Mayo Clinic

Scottsdale, Arizona, United States

Key Dates

Start Date

June 12, 2020

Primary Completion Date

April 29, 2021

Completion Date

April 29, 2021

Last Updated

July 26, 2021

Enrollment

ACTUAL participants

Conditions

Episodic Migraine

Interventions

Sham Treatment Location

DEVICE

Verum Treatment Location

DEVICE

Prophylactic Treatment With Atorvastatin for Episodic Migraine.

NCT06248671

Episodic Migraine

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ACTIVE_NOT_RECRUITINGPHASE3

A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine

NCT03432286

Episodic Migraine

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COMPLETEDPHASE4

Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention

NCT05207865

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 26, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain

Inclusion Criteria

Exclusion Criteria

Prophylactic Treatment With Atorvastatin for Episodic Migraine.

A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine

Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention

Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Receiving CGRP Therapy (ReMMiD-C)

HD-EEG Connectivity Changes in Migraine Patients Undergoing Treatment With Anti-CGRP mAbs

Transnasal Cooling for Migraine