Resistant MigraineRECLAIM-IINCT07719608
A Pivotal Clinical Study to Evaluate the MySalvia System for the Treatment of Resistant Migraine
A study testing Neurostimulator in people with Resistant Migraine and Chronic Migraine Headache, run by Salvia BioElectronics at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 84 years
- Conditions the study is for
- Resistant Migraine, Chronic Migraine Headache, Headache (Migraine)
- What is being tested?
- Neurostimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Dec 2026to 1 May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Queen City Clinical Research, PLLC
Charlotte, North Carolina, 28211
Shannon Hill, Director of Clinical Research, 704-405-6150, recruitment@qccresearch.com
Leo Kapural, MD
- Recruiting
Vista Clinical Research
Newnan, Georgia, 30265
Debra Helton, CCRC, MLT, 770-755-6914, dhelton@vistaclinresearch.com
Sandeep Vaid, MD
- Recruiting
MedStar Health Research Institute
Olney, Maryland, 20832
Meselu Amare, Clinical Research Coordinator II, 301-570-8508, Meselu.B.Amare@medstar.net
Dr. Jessica Ailani, MD
About this study
Official title: Randomized, Double-Blind, Controlled Pivotal Trial of the MySalvia System for the Treatment of Resistant Migraine
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.
- Being tested
- Neurostimulator
- Keywords
- Neuromodulation, Chronic Migraine, Resistant Migraine, Headache, HIgh Frequency Episodic Migraines
- Medical subject headings
- Migraine Disorders, Cluster Headache, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurostimulatorDevice
A neurostimulation system that consists of implantable and non-implantable components that work together to deliver mild electrical signals to targeted craniofacial nerves.
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Active comparator | Not described Receives: Device: Neurostimulator |
| Active Control Group | Active comparator | Not described Receives: Device: Neurostimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint - Efficacy
Proportion of participants achieving a ≥30% reduction in Monthly Migraine Days (MMD) at 24 weeks post device activation compared to baseline.
Measured: 24 weeks
Primary Outcome Measure - Safety
Incidence of serious procedure-, device- and/or stimulation-related adverse events among all participants at 24 weeks post-device activation.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salvia BioElectronics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719608
- Sponsor's protocol ID
- SCI-05-RM
- Acronym
- RECLAIM-II
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Controlled Pivotal Trial of the MySalvia System for the Treatment of Resistant Migraine
- ClinicalTrials.gov ID
- NCT07719608
- Acronym / sponsor ID
- RECLAIM-II / SCI-05-RM
- Keywords
- Neuromodulation, Chronic Migraine, Resistant Migraine, Headache, HIgh Frequency Episodic Migraines
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Salvia BioElectronicsIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group | Active comparator | Device: Neurostimulator |
| Active Control Group | Active comparator | Device: Neurostimulator |
Who may qualify
- Ages
- 22 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurostimulatorA neurostimulation system that consists of implantable and non-implantable components that work together to deliver mild electrical signals to targeted craniofacial nerves. | Device | Active Control Group, Active Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurostimulator in people with Resistant Migraine and Chronic Migraine Headache, run by Salvia BioElectronics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint - Efficacy (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.