Resistant Migraine study: Neurostimulator
Official title A Pivotal Clinical Study to Evaluate the MySalvia System for the Treatment of Resistant Migraine
ClinicalTrials.gov ID: NCT07719608
What this study is testing
- What it's testing
- The study aims to see if the MySalvia System is safe and works for preventing migraines in people who still get headaches despite other therapies.
- Who it's for
- Adults who have resistant or chronic migraines that have not improved with other treatments.
- What's involved
- Participants will receive a small implant that sends electrical signals to the nervous system, and will have follow‑up visits and medical tests to monitor safety and effectiveness.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 84
You may be able to join if
- 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
- 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)...
You likely can't join if
- Presence of another chronic primary or secondary headache disorder, unless the participant can reliably differentiate these headaches attacks from...
- 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.
- Presence of metal or magnet implants in the skull or cranial region (e.g. skull plates, seeds)
See the full eligibility 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
- 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.
- Not better accounted for by another ICHD-3 diagnosis 4. History of migraine onset before 50 years of age 5.
- 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...
- 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.
- Presence of metal or magnet implants in the skull or cranial region (e.g. skull plates, seeds)
- Pregnant, nursing or not using contraception.
The study team makes the final eligibility decision.
Where it is enrolling
- Newnan, Georgia, United States
- Olney, Maryland, United States
- Charlotte, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 84 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Newnan, Georgia, United States; Olney, Maryland, United States; Charlotte, North Carolina, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.