A Pivotal Clinical Study to Evaluate the MySalvia System for the Treatment of Resistant Migraine

Part of paid clinical trials in Newnan, Georgia.

Sponsor
Salvia BioElectronics
Study ID
NCT07719608
Status
Recruiting
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Conditions

  • Chronic Migraine Headache
  • Headache (Migraine)
  • Headache, Cluster
  • Resistant Migraine

Eligibility Criteria

Sex
ALL
Age
22 Years - 84 Years
Healthy Volunteers
Not accepted

Interventions

  • Neurostimulator — DEVICE
    A neurostimulation system that consists of implantable and non-implantable components that work together to deliver mild electrical signals to targeted craniofacial nerves.

Study Details

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.

Key Dates

First listed
Jul 22, 2026
Start date
Dec 1, 2026
Status verified
Aug 2026
Primary completion
Oct 1, 2028
Completion
May 1, 2031

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active Group
  • Active Comparator: Active Control Group

Primary Outcome Measure

Primary Endpoint - Efficacy [ Time Frame: 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vista Clinical ResearchNewnanGeorgia30265
Debra Helton, CCRC, MLT
[email protected]
770-755-6914
Sandeep Vaid, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Vista Clinical Research· Newnan, GA

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