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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
A neurostimulation system that consists of implantable and non-implantable components that work together to deliver mild electrical signals to targeted craniofacial nerves.
Vista Clinical Research
Newnan, Georgia, United States
RECRUITINGMedStar Health Research Institute
Olney, Maryland, United States
RECRUITINGQueen City Clinical Research, PLLC
Charlotte, North Carolina, United States
RECRUITINGPrimary Endpoint - Efficacy
Proportion of participants achieving a ≥30% reduction in Monthly Migraine Days (MMD) at 24 weeks post device activation compared to baseline.
Time frame: 24 weeks
Primary Outcome Measure - Safety
Incidence of serious procedure-, device- and/or stimulation-related adverse events among all participants at 24 weeks post-device activation.
Time frame: 24 Weeks
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