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RecruitingNCT07719608RECLAIM-IIUpdated Aug 28, 2026

A Pivotal Clinical Study to Evaluate the MySalvia System for the Treatment of Resistant Migraine

An interventional study of Neurostimulator in Resistant Migraine, Chronic Migraine Headache and Headache (Migraine), sponsored by Salvia BioElectronics. Recruiting at 3 sites in United States. Open to participants aged 22 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Salvia BioElectronics · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
22 Years to 84 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Resistant Migraine
  • Chronic Migraine Headache
  • Headache (Migraine)
  • Headache, Cluster

Keywords

  • Neuromodulation
  • Chronic Migraine
  • Resistant Migraine
  • Headache
  • HIgh Frequency Episodic Migraines
03

In context

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

This study's planned enrollment of 150 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Salvia BioElectronics is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 .
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    Active Group

    Device: Neurostimulator

  • Active comparator
    Active Control Group

    Device: Neurostimulator

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.

06

What researchers measure

Primary outcomes

  1. Primary Endpoint - Efficacy

    Proportion of participants achieving a ≥30% reduction in Monthly Migraine Days (MMD) at 24 weeks post device activation compared to baseline.

    Time frame: 24 weeks

  2. Primary Outcome Measure - Safety

    Incidence of serious procedure-, device- and/or stimulation-related adverse events among all participants at 24 weeks post-device activation.

    Time frame: 24 Weeks

07

Study locations

3 of 3 sites recruiting
  • Vista Clinical Research
    Newnan, Georgia 30265, United States
    Recruiting
  • MedStar Health Research Institute
    Olney, Maryland 20832, United States
    Recruiting
    • Meselu Amare, Clinical Research Coordinator II · ContactMeselu.B.Amare@medstar.net · 301-570-8508
    • Dr. Jessica Ailani, MD · Principal investigator
  • Queen City Clinical Research, PLLC
    Charlotte, North Carolina 28211, United States
    Recruiting
    • Shannon Hill, Director of Clinical Research · Contactrecruitment@qccresearch.com · 704-405-6150
    • Leo Kapural, MD · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Oct 2028, 22 months later.

Of 49 industry-sponsored interventional studies with no phase under Migraine Disorders, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 22. This study's planned 22 months is above that.

Counting every sponsor, half of 358 studies reached it within 15 months; a quarter within 7 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2026
First posted
Jul 22, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Oct 1, 2028
CompletionEst.
May 1, 2031
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07719608
Lead sponsor
Salvia BioElectronics
Responsible party
Sponsor
First posted
Jul 22, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Oct 1, 2028 (estimated)
Completion
May 1, 2031 (estimated)
Last update
Aug 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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