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Electric pulses to the head: new device aims to stop cluster headaches

NCT ID NCT07113470

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 17, 2026 · Updated 4 times

Summary

This small study tests an implanted device that sends mild electrical pulses to nerves in the head and neck to prevent chronic cluster headaches. Ten adults who did not get better with the drug verapamil will receive the stimulator. Researchers will check how safe it is and whether it reduces headache attacks.

What this could mean

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

Active substance
implanted nerve stimulator (PRIMUS system)
What this could lead to
If it works, this could offer a new drug-free option for preventing chronic cluster headaches in people who don't get relief from standard medications.
What could go wrong
This is a very small early study with only 10 people and no placebo group, so results may not apply broadly. The device requires surgery and carries risks like infection or nerve damage.

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 10 people

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

Started

Apr 2026

Expected to finish

Dec 2028

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.

Inclusion Criteria: 1. Able and willing to provide informed consent 2. 18 years of age or older 3. Documented Primary Chronic Cluster Headache, for at least 1 year as per ICHD-3 criteria Exclusion Criteria: 1. 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 2. Secondary Cluster Headache

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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

How to take part

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

  1. The places running it

    1 site. 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

  • LUMC Leids Universitair Medisch Centrum

    RECRUITING

    Leiden, Netherlands

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