Neurostimulation Device for Treatment of Migraine Headache

Completed · Not applicable

Conditions studied: Migraine Headache

In brief

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.

Key facts

Study ID

NCT01630044

Run by

Scion NeuroStim

People needed

3

Starts

2012-05-01

Expected to finish

2013-04-01

Last updated by the study team

2025-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Duke Medicine / Neurology — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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