A Non-Invasive Neuromodulation Device for Treatment of Migraine Headache
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Migraine Headache, Episodic
- Sponsor
- Scion NeuroStim
- Enrollment
- 100
- Locations
- 6
- Primary Endpoint
- Change in Number of Monthly Migraine Headache Days
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
This is a randomized, blinded study designed to assess the efficacy of a portable, non-invasive neuromodulation system for the treatment of episodic migraine headaches.
Detailed Description
This is a multi-center, triple-blinded, placebo-controlled, randomized pivotal trial evaluating the adjunctive prophylactic treatment of episodic migraine headache using a caloric vestibular stimulation (CVS) device developed by Scion NeuroStim, LLC (SNS). This study has been reviewed by the FDA and is categorized as posing NSR (nonsignificant risk).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Number of Monthly Migraine Headache Days
Time Frame: after 84 days of Device use
Change in the average total number of Monthly Migraine Headache Days (number of days in the month that a participant experienced a migraine) after 3 months of treatment comparable to the pre-device use Baseline Period of 1 month, as reported in a headache diary. Negative number indicated improvement (a reduction in the average number of migraine headache days experienced per month).
Secondary Outcomes
- Number of Monthly Migraine Headache Days (Reduction by by 50% or More)(after 84 days of Device use)
- Total Monthly Headache Pain Score(after 84 days of Device use)
- (Safety Measure) Mood and Cognition - Change in Beck Depression Index Score(after 84 days of Device use)
- (Safety Measure) Dizziness: Verify the Absence of Change in Material Dizziness (Berg Balance)(after 84 days of Device use)
- (Safety Measure) Mood and Cognition - Change in Digit Symbol Coding Cognitive Speed(after 84 days of Device use)
- (Safety Measure) Mood and Cognition Measure - Change in Short Term Memory Test Scores(after 84 days of Device use)
- Average of Monthly Treated Headaches (Acute Anti-migraine Prescription Drug Intake)(after 84 days of device use)