Testing an Implanted Nerve Stimulator to Prevent Migraine That Resists Treatment
Tests the MySalvia implanted stimulator for preventing migraine in adults whose migraine resists treatment.
Plain-language title generated from the registry record
Registry title: A Pivotal Clinical Study to Evaluate the MySalvia System for the Treatment of Resistant Migraine
Key facts
- Where
- Charlotte, Newnan, and Olney, United StatesSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 22 and 84 years old?
Source: NCT07719608, who can take part
Where in United States
- Queen City Clinical Research, PLLCCharlotte, United StatesTaking people
- Vista Clinical ResearchNewnan, United StatesTaking people
- MedStar Health Research InstituteOlney, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Salvia BioElectronics
- Trial code
- NCT07719608
- Record updated
- 28 August 2026
- Original description
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.Read full original descriptionShow less
Randomized, Double-Blind, Controlled Pivotal Trial of the MySalvia System for the Treatment of Resistant Migraine
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.
Inclusion: Meets resistant migraine criteria:; 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; 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; 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; 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: 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); Presence of metal or magnet implants in the skull or cranial region (e.g. skull plates, seeds); 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; 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); Pregnant, nursing or not using contraception.