A Pivotal Clinical Study to Evaluate the MySalvia System for the Treatment of Resistant Migraine
RecruitingNot applicableNCT07719608
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Randomized, Double-Blind, Controlled Pivotal Trial of the MySalvia System for the Treatment of Resistant Migraine
- Conditions
- Resistant Migraine
- Chronic Migraine Headache
- Headache (Migraine)
- Headache, Cluster
- Interventions
- Device: Neurostimulator
- Sponsor
- Salvia BioElectronics
- Start date
- 2026-12-01
- Primary completion
- 2028-10-01
- Sex
- All
- Age range
- from 22 Years to 84 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07719608