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Electric zaps to the head may ease cluster headaches

NCT ID NCT05868044

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests the safety of a new device called PRIMUS that uses mild electrical pulses on nerves in the forehead and back of the head to treat chronic cluster headache. Five people with frequent, hard-to-treat attacks will be enrolled. The goal is to see if the device is safe and to gather first data on how well it works.

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 5 people

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

Started

May 2023

Expected to finish

Dec 2026

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 years and older

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 * Documented chronic cluster headache for at least 1 year as per ICHD-3 criteria * Attack frequency of ≥ 4 attacks per week for ≥ 4 weeks before enrolment * Documented failure of verapamil (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated) * Stable on preventive treatment for at least two weeks prior to enrolment. * Agree to refrain from starting new prophylactic cluster headache medication or other preventive 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 enrolment) or willing to undergo an MRI to exclude structural lesions potentially causing headache * Able and willing to complete a headache Diary Main Exclusion Criteria: * Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from cluster headache attacks based on the quality and associated symptoms * Concomitant neuromodulation, except tVNS * Previous failure to any 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 or implantable cardioverter defibrillator (ICD) * Suboccipital infiltrations with steroids and/or local anaesthetics or use of oral steroids in the past 3 months * Use of botulinum toxin injections in the past 12 weeks * Calcitonin gene-related peptide inhibitors started less than 12 weeks prior to enrolment * Women of childbearing age who are pregnant, nursing or not using contraception

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Conditions

The condition(s) this trial relates to.

cluster headache syndrome

As listed by the trial registrant

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

Chronic cluster headache

Contacts and locations

Locations

  • Resolve Pain

    Buderim, Queensland, 4556, Australia

More trials for these conditions

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