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

NCT ID
NCT07719608
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Salvia BioElectronics
Conditions
Chronic Migraine Headache, Headache (Migraine), Headache, Cluster, Resistant Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Randomized, Double-Blind, Controlled Pivotal Trial of the MySalvia System for the Treatment of Resistant Migraine

Enrollment: 150 participants (Estimated).

What is being studied

  • Intervention: Electrical Equipment and Supplies
  • Intervention: Electrodes
  • Intervention: Electrodes, Implanted
  • Intervention: Equipment and Supplies
  • Intervention: Implantable Neurostimulators
  • Device: Neurostimulator
  • Intervention: Prostheses and Implants

Who may be eligible

Ages
22 Years to 84 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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 contraindication to three or more (but not all) classes of at least one evidence-based medication. The classes must include Onabotulinumtoxin A and CGRP mabs/antagonists. 4. Not better accounted for by another ICHD-3 diagnosis 4. History of migraine onset before 50 years of age 5. Stable dose of all preventive migraine medication(s) and alternative therapies for at least three months before the start of the eligibility phase Exclusion Criteria: * Presence of another chronic primary or secondary headache disorder, unless the participant can reliably differentiate these headaches attacks from migraine attacks, based on the pain characteristics and associated symptoms * Concurrent use of any invasive or non-invasive neuromodulation. * Previous inadequate response to an implantable neuromodulation device for headache or pain management. * Have an existing active implantable medical device nearby the implant location (e.g. DBS, cochlear implant). * Use of onabotulinum toxin A injections for the treatment of migraine in the past 3 months. Presence of an active implantable medical device (e.g. pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implant). * Presence of metal or magnet implants in the skull or cranial region (e.g. skull plates, seeds) * Pregnant, nursing or not using contraception.

Study locations

3 study locations are listed.

Recruiting site status is explicitly provided for 3 locations; 3 are listed as Recruiting.

Countries: United States

  • Georgia, United States: 1
  • Maryland, United States: 1
  • North Carolina, United States: 1

Sample of listed locations

  • Vista Clinical Research — Newnan, Georgia, 30265, United States — Recruiting
  • MedStar Health Research Institute — Olney, Maryland, 20832, United States — Recruiting
  • Queen City Clinical Research, PLLC — Charlotte, North Carolina, 28211, United States — Recruiting

Study details

Start date
December 1, 2026
Primary completion date
October 1, 2028
Completion date
May 1, 2031
First posted
July 22, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07719608
Registry last updated
August 28, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07719608 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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