Chronic Migraine Headache, Headache, Cluster, Headache (Migraine), Resistant Migraine
Conditions
Keywords
Neuromodulation, Chronic Migraine, Resistant Migraine, Headache, HIgh Frequency Episodic Migraines
Brief summary
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.
Interventions
DEVICENeurostimulator
A neurostimulation system that consists of implantable and non-implantable components that work together to deliver mild electrical signals to targeted craniofacial nerves.
Sponsors
Salvia BioElectronics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 84 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint - Efficacy | 24 weeks | Proportion of participants achieving a ≥30% reduction in Monthly Migraine Days (MMD) at 24 weeks post device activation compared to baseline. |
| Primary Outcome Measure - Safety | 24 Weeks | Incidence of serious procedure-, device- and/or stimulation-related adverse events among all participants at 24 weeks post-device activation. |
Countries
United States
Outcome results
None listed