Neurostimulation Device for Treatment of Migraine Headache

Not Applicable

Completed

• Conditions: Migraine Headache
• Interventions: Device: TNM device

• Registration Number: NCT01630044
• Lead Sponsor: Scion NeuroStim

Brief 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.

Detailed Description

This study is a single-center, unblinded, non-randomized clinical trial for adjunctive prophylactic treatment of episodic migraine headache using neuromodulation device developed by Scion NeuroStim, LLC (SNS). The investigational use of the device for episodic migraine headache has been reviewed by the FDA and is classified as NSR (non-significant risk).

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-28
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TNM device, active treatment	TNM device	This is an active-only assessment of the experimental neuromodulation device

Primary Outcome Measures

Name	Time	Method
Number of migraine headache days	Length of the study, about 71 days	Daily Headache Diary will be used by subject. A headache day is defined as a twenty-four hour period which the subject has a headache.
Severity of each and of all headaches	Length of study, 71 days	Daily Headache Diary will be used by subject. Subject will assign the level of pain based on an eleven-point pain measurement scale from zero (no pain) to ten (most intense pain).

Secondary Outcome Measures

Name	Time	Method
Total Monthly Headache Pain Score	Length of study, about 71 days	The monthly measure would be the cumulative maximal headache pain scores for all headache days (days on which the subject's head pain level is one or higher on the pain measurement scale) during the month.

Trial Locations

Locations (1)

Duke Medicine / Neurology; 🇺🇸 Durham, North Carolina, United States