NCT07719608

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
54mo left

Started Dec 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2031

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

1.8 years

First QC Date

July 17, 2026

Last Update Submit

August 27, 2026

Conditions

Resistant MigraineChronic Migraine HeadacheHeadache (Migraine)Headache, Cluster

Keywords

NeuromodulationChronic MigraineResistant MigraineHeadacheHIgh Frequency Episodic Migraines

Outcome Measures

Primary Outcomes (2)

  • Primary Endpoint - Efficacy

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

    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.

    24 Weeks

Study Arms (2)

Active Group

ACTIVE COMPARATOR
Device: Neurostimulator

Active Control Group

ACTIVE COMPARATOR
Device: Neurostimulator

Interventions

NeurostimulatorDEVICE

A neurostimulation system that consists of implantable and non-implantable components that work together to deliver mild electrical signals to targeted craniofacial nerves.

Active Control GroupActive Group

Eligibility Criteria

Age22 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Vista Clinical Research

Newnan, Georgia, 30265, United States

RECRUITING

MedStar Health Research Institute

Olney, Maryland, 20832, United States

RECRUITING

Queen City Clinical Research, PLLC

Charlotte, North Carolina, 28211, United States

RECRUITING

MeSH Terms

Conditions

Migraine DisordersCluster HeadacheHeadache

Interventions

Implantable Neurostimulators

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTrigeminal Autonomic CephalalgiasPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrodes, ImplantedElectrodesElectrical Equipment and SuppliesEquipment and SuppliesProstheses and Implants

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2026

First Posted

July 22, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

May 1, 2031

Last Updated

August 28, 2026

Record last verified: 2026-08

Locations

US(3)