NCT07719608 · Salvia BioElectronics
A Pivotal Clinical Study to Evaluate the MySalvia System for the Treatment of Resistant Migraine
(RECLAIM-II)
What this study is about
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.
View original scientific description
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
DEVICE
Neurostimulator
A neurostimulation system that consists of implantable and non-implantable components that work together to deliver mild electrical signals to targeted craniofacial nerves.
Primary outcome measures
Primary Endpoint - Efficacy
Time frame: 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
Time frame: 24 Weeks
Incidence of serious procedure-, device- and/or stimulation-related adverse events among all participants at 24 weeks post-device activation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Meets resistant migraine 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
- 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
- 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.
- 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
- Newnan, Georgia
- Olney, Maryland
- Charlotte, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 25, 2026 · Source of record for eligibility and locations