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Tiny trial hopes to zap migraines away with implanted nerve device

NCT ID NCT05858801

Symptom relief Sponsor: Salvia BioElectronics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This early study tests a new device called PRIMUS that stimulates nerves in the head and face to treat chronic migraine. Only 7 people with hard-to-treat migraines are taking part. The main goal is to see if the device is safe, not yet if it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PRIMUS system (a craniofacial peripheral nerve stimulation device)
What this could lead to
If it works, this could point toward a new drug-free option for people with chronic migraine who haven't found relief from other treatments.
What could go wrong
This is a very early, tiny study (7 people) focused only on safety, not effectiveness. The device may not reduce migraines, and risks like infection or nerve damage are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

7 people

The number who actually took part.

Started

May 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 84 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Main Inclusion Criteria: * Able and willing to provide informed consent * Age ≥ 18 years and ≤ 84 years at time of consent * Documented Chronic Migraine, defined as at least eight migraine days/month, for at least 1 year. * Developed migraine before the age of 50 * Documented failure of 3 or more other preventive therapies (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated) from which at least 1 of the following 2: CGRP mAbs or Onabotulinumtoxin A * Have at least 1 headache free day per month * Stable on preventive migraine drugs and alternative treatment for at least three months prior to enrollment. * Agree to refrain from starting new preventive migraine drugs or other preventive alternative migraine treatments, from 4 weeks before entering the baseline period throughout the duration of the study. * MRI available (not older than 4 years prior to study enrollment) or willing to undergo an MRI to exclude structural lesions potentially causing headache * Able and willing to complete a daily headache eDiary Main Exclusion Criteria: * Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from migraine attacks, based on the quality of pain and associated symptoms. * Concomitant neuromodulation * Previous failure to an implantable neuromodulation device for neurovascular headache * Have an existing Active Implantable Medical Device nearby the implant location (e.g. DBS, cochlear implant, …) * Metal implants in the skull (e.g. skull plates, seeds) nearby the implant. * Have a pacemaker of implantable cardioverter defibrillator (ICD) * Current Opioid Use, defined as one or more opioids on more than 4 days/month for 3 consecutive months. * Use of botulinum toxin injections in the past 3 months. * Women of childbearing age who are pregnant, nursing or not using contraception

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic migraine

Contacts and locations

Locations

  • AZ Delta

    Roeselare, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.