A Non-Invasive Neuromodulation Device for Treatment of Migraine Headache
- Conditions
- Migraine Headache, Episodic
- Interventions
- Device: neuromodulation for episodic migraine headache
- Registration Number
- NCT01899040
- Lead Sponsor
- Scion NeuroStim
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description active device neuromodulation for episodic migraine headache A standardized active neuromodulation waveform will be used for all active Device patients at all Study sites. The Device will be used twice daily. placebo device neuromodulation for episodic migraine headache A standardized placebo neuromodulation waveform will be used for all placebo Device patients at all Study sites. The Device will be used twice daily.
- Primary Outcome Measures
Name Time Method Number of monthly migraine headache days after 84 days of Device use During the third Month of Device use, the average total number of Monthly Migraine Headache Days will be lower than comparable averages derived from the Pre-use Baseline Period
- Secondary Outcome Measures
Name Time Method Number of monthly migraine headache days (reduction by by 50% or more) after 84 days of Device use A reduction of 50% or more in monthly Migraine Headache Days during the third Month of Device use as compared with the Pre-use Baseline Period.
Mood and cognition measures - Change in mood scores after 84 days of Device use A patient's Pre-use Baseline Period mood scores will be compared with those at the end of the Device use period. Mood scores will be assessed for: a decline, no change, or an improvement.
Verify the absence of material dizziness after 84 days of Device use The principal safety endpoint for the Study is to verify the absence of material dizziness, with the associated risk of falls, as a consequence of using the Device.
Mood and cognition measures - Change in cognitive speed scores after 84 days of Device use A patient's Pre-use Baseline Period cognitive speed scores will be compared with those at the end of the Device use period. Cognitive speed scores will be assessed for: a decline, no change, or an improvement.
Mood and cognition measures - Change in memory scores after 84 days of Device use A patient's Pre-use Baseline Period memory scores will be compared with those at the end of the Device use period. Memory scores will be assessed for: a decline, no change, or an improvement.
Use of acute medications - change in number of treated headaches after 84 days of device use During the third month of device use, the number of abortive medications taken will be less than the number taken in the baseline month
Total monthly pain score after 84 days of Device use During the third Month of Device use, the average Total Monthly Headache Pain Scores will be lower than comparable averages derived from the Pre-use Baseline Period.
Trial Locations
- Locations (6)
Naval Medical Center
🇺🇸San Diego, California, United States
Carolina Headache Institute
🇺🇸Chapel Hill, North Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States
Headache Wellness Center
🇺🇸Greensboro, North Carolina, United States
Kent University
🇬🇧Kent, Canterbury, United Kingdom
Michigan Headache and Neurological Institute
🇺🇸Ann Arbor, Michigan, United States