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Neurostimulation Device for Treatment of Migraine Headache | Clinical Trials | Clareo Health

COMPLETEDNA

Neurostimulation Device for Treatment of Migraine Headache

Clinical Pilot Study to Evaluate a Non-Invasive, Neurostimulation Device for Treatment of Migraine Headache

NCT01630044•Scion NeuroStim

Summary

This is a single-site, prospective, non-randomized and open label study to investigate the feasibility of home-use CVS for the prevention of episodic migraine headache and specifically to better understand what type of waveform to apply.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A history of at least four, and not more than fourteen total monthly headache days of which between four and nine were migraine headache days. (Note: Patients were permitted continued access to migraine abortive medications and were being treated at the Duke University headache clinic.)
•A history of some responsiveness (incomplete) to at least one and a maximum of two prophylactic pharmaceutical therapies (utilized concurrently);
•The investigator must have confidence in the patient's ability to reliably complete and return the Daily Headache Diary.
•Subject must be at least 18 years of age.

Exclusion Criteria

•Individuals who were pregnant, who had a history of cardiovascular disease, who worked night shifts or who had vestibular migraine, menstrual migraine, post-traumatic migraine, a history of unstable mood disorder or unstable anxiety, moderate or greater hearing loss or a history of traumatic brain injury.
•A history within the last six months of tobacco use, narcotic or barbiturates use or experiencing one or more analgesic rebound headaches.

Locations (1)

Duke Medicine / Neurology

Durham, North Carolina, United States

Key Dates

Start Date

May 1, 2012

Primary Completion Date

April 1, 2013

Completion Date

April 1, 2013

Last Updated

March 30, 2025

Enrollment

ACTUAL participants

Conditions

Migraine Headache

Interventions

TNM device

DEVICE

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RECRUITINGNA

A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine

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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: March 30, 2025Data 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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Neurostimulation Device for Treatment of Migraine Headache

Inclusion Criteria

Exclusion Criteria

Light Exposure, Migraine Outcomes, and Sleep Quality

A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine

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Migraine With Aura and Patent Foramen Ovale: Identification of Biomarkers to Select Patients In Whom Intervention Would Be Beneficial (MANET)

Efficacy, Tolerability, and Safety of DFN-15

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