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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years to 84 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe and effective the MySalvia System is at preventing migraines in adults whose migraines resist treatment. The system is a device placed in the body through a small procedure that changes nerve activity.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a documented migraine diagnosis that meets study standards. This may include migraine with or without aura (warning symptoms such as vision changes), or chronic migraine.
  • Have at least 2 of these: severe effects on daily life, constant or nearly constant headache between migraine attacks, or at least 8 migraine days a month.
  • Have tried or been unable to use medicines from at least 3, but not all, migraine drug groups. These must include onabotulinumtoxin A (Botox) and CGRP medicines. They must have failed to cut migraine days by half, caused side effects you could not tolerate, or been unsafe for you to use.
  • Have headaches that are not better explained by another headache diagnosis.
  • Have had migraines start before age 50.
  • Have kept the same doses of all migraine prevention medicines and the same alternative treatments for at least 3 months before the study's eligibility phase.

Who can't join

  • Have another long-term headache disorder, unless you can reliably tell those headaches apart from your migraines.
  • Currently use any treatment that changes nerve activity, whether inside or outside the body.
  • Previously had a poor response to an implanted device used to change nerve activity for headaches or pain.
  • Have an active implanted medical device, such as a pacemaker, heart defibrillator, nerve stimulator, or cochlear hearing implant, including one near the planned implant site.
  • Have had Botox injections for migraine in the past 3 months.
  • Have metal or magnet implants in your skull or head, such as skull plates.
  • Are pregnant, breastfeeding, or not using birth control.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (3)

GA

MD

NC