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New device zaps migraines away in Drug-Resistant patients

NCT ID NCT06450444

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study tests a device called the PRIMUS System that uses mild electrical pulses to stimulate nerves in the head and neck. It is for people with chronic or frequent migraine who have not gotten relief from at least three preventive medicines. The goal is to see if the device safely reduces the number of migraine days per month. About 110 adults will take part.

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

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Jan 2029

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.

Inclusion Criteria: * Diagnosis of migraine as defined by the ICHD-3 Classification (with or without aura) with a history of chronic or high-frequency episodic migraine for at least 1 year prior to screening * Failure of 3 or more preventive pharmacological therapies * Stable on preventive migraine treatments * Psychologically stable Exclusion Criteria: * Concomitant invasive or non-invasive neuromodulation * Previous exposure to an implantable neuromodulation device for headache * 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. * Use of local corticosteroid injections in the occipital or supra-orbital region in the past 3 months prior to enrollment. * Not 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 High frequency episodic migraine

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Delta

    RECRUITING

    Roeselare, West Vlaanderen, Belgium

  • AZ Groeninge

    RECRUITING

    Kortrijk, West Vlaanderen, Belgium

  • AZ Oostende

    RECRUITING

    Ostend, West Vlaanderen, Belgium

  • AZ Sint Jan Brugge

    RECRUITING

    Bruges, West Vlaanderen, 8000, Belgium

  • Erasmus MC Rotterdam

    RECRUITING

    Rotterdam, Netherlands

  • Genesis Research Services

    TERMINATED

    Broadmeadow, New South Wales, NSW, 2292, Australia

  • Jessa Hasselt

    RECRUITING

    Hasselt, Limburg, 3500, Belgium

  • Private Practice Dr. Sava

    ACTIVE_NOT_RECRUITING

    Saint-Nicolas, Liège, Belgium

  • Resolve Pain

    TERMINATED

    Buderim, Queensland, 4556, Australia

  • St. Antonius Nieuwegein

    RECRUITING

    Nieuwegein, Netherlands

  • ZAS Antwerpen, Campus Sint-Augustinus

    RECRUITING

    Wilrijk, Antwerpen, Belgium

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