Randomized, Double-Blind, Controlled Pivotal Trial of the MySalvia System for the Treatment of Resistant Migraine
Salvia BioElectronics
Summary
The purpose of this pivotal clinical study is to evaluate the safety and effectiveness of the MySalvia System, a minimally invasive implantable neuromodulation therapy, for the preventive treatment of adults with resistant migraine.
Eligibility
- Age range
- 22–84 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Meets resistant migraine criteria: 1. Documented diagnosis of 1.1 migraine without aura and/or 1.2 migraine with aura and/or 1.3 chronic migraine according to ICHD-3 2. Headache requiring two of the following: * Leads to considerable impairment in personal, educational and/or occupational areas of functioning (MIDAS rating of severe or very severe) * Concomitant continuous or near continuous headache between migraine attacks * Eight or more monthly migraine days 3. Lack of 50% reduction in monthly migraine days and/or intolerable side effects and/or absolute con…
Interventions
- DeviceNeurostimulator
A neurostimulation system that consists of implantable and non-implantable components that work together to deliver mild electrical signals to targeted craniofacial nerves.
Location
- Vista Clinical ResearchNewnan, Georgia