A Pivotal Clinical Study to Evaluate the MySalvia System for the Treatment of Resistant Migraine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-84
SponsorSalvia BioElectronics
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Neurostimulator
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov