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A Pivotal Clinical Study to Evaluate the MySalvia System for the Treatment of Resistant Migraine
Sponsor: 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.
Official title: Randomized, Double-Blind, Controlled Pivotal Trial of the MySalvia System for the Treatment of Resistant Migraine
Key Details
Gender
All
Age Range
22 Years - 84 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-12-01
Completion Date
2031-05-01
Last Updated
2026-08-28
Healthy Volunteers
No
Interventions
Neurostimulator
A neurostimulation system that consists of implantable and non-implantable components that work together to deliver mild electrical signals to targeted craniofacial nerves.
Locations (3)
Vista Clinical Research
Newnan, Georgia, United States
MedStar Health Research Institute
Olney, Maryland, United States
Queen City Clinical Research, PLLC
Charlotte, North Carolina, United States