MySalvia System for Resistant Migraine: a minimally invasive implant to prevent migraines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pivotal, interventional study evaluates the safety and effectiveness of the MySalvia System, a minimally invasive implantable neuromodulation device, for preventive treatment of adults with resistant migraine. Participants are adults with documented migraine with or without aura or chronic migraine who experience substantial impairment and have not achieved adequate relief with prior therapies. The trial uses a neurostimulator to deliver targeted neuromodulation and will assess changes in monthly migraine days and related outcomes. Eligible participants must meet specific diagnostic criteria, disease burden, and stable preventive medication use before enrollment. The study is conducted at multiple clinical sites in Georgia, Maryland, and North Carolina under the lead sponsor Salvia BioElectronics.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Bilateral middle meningeal artery embolization for refractory chronic migraine

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.