Neurostimulation Device for Treatment of Migraine Headache

Scion NeuroStim

Status

Completed

Conditions

Migraine Headache

Treatments

Device: TNM device

Study type

Interventional

Funder types

Industry

Identifiers

NCT01630044

Pro00037089

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.