Stimulation Headset for the Prevention of Migraine Headache
Research type
Research Study
Full title
A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache
IRAS ID
220432
Contact name
Dawn Reilly-O'Dell
Contact email
Sponsor organisation
Scion NeuroStim, LLC
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 2 days
Research summary
This study is a multi-center, triple-blinded, placebo-controlled and randomized clinical investigation into the duration of gain provided by use of a non-invasive, home-use neuromodulation device in the adjunctive, prophylactic treatment of migraine headaches. This study adds to the initial evidence of the device’s safety and effectiveness over a three-month period that was established by the original randomized, controlled pivotal study (i.e. IRAS 130644).
Eligible subjects will be adults that have been diagnosed with episodic (i.e. acute) migraines with or without aura at least six months prior to study entry and have had partial but limited success with other therapies.
Sites will be headache centers within the United States and England. Funding will be provided by the device manufacturer.
For each subject, duration of the study will be approximately nine months and will include 6 months of once or twice daily treatments followed by 3 months of observational follow up. Each treatment will last roughly 19 minutes.REC name
London - Stanmore Research Ethics Committee
REC reference
17/LO/0472
Date of REC Opinion
19 May 2017
REC opinion
Further Information Favourable Opinion