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Could a forehead device stop seizures in veterans?

NCT ID NCT07220161

Disease control Sponsor: Baylor College of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 2 times

Summary

This study tests whether a non-invasive forehead device called Cefaly, already approved for migraines, can reduce seizures in veterans with drug-resistant epilepsy. Twenty-four veterans will be split into two groups: one gets standard care plus the device, the other gets standard care alone, then they switch. Researchers will track seizure frequency and quality of life over 12 months.

What this could mean

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

Active substance
Cefaly device (non-invasive trigeminal nerve stimulation)
What this could lead to
If it works, this could offer a non-invasive, drug-free option to reduce seizures in people with epilepsy that doesn't respond to medication.
What could go wrong
This is a small, early-stage trial with only 24 veterans. The device is FDA-approved for migraines, not epilepsy, so its effectiveness for seizures is unproven. Results may not apply to all epilepsy types.

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 24 people

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

Started

May 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 65 years

Sex

Male participants only

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: * Adults age 18 to 65 years of age at time of consent * Subject must have a confirmed diagnosis of epilepsy of at least 1 year, specified as focal onset epilepsy. * Focal epilepsy with motor signs * A minimum seizure frequency of one seizure over a 4-week period * Subject must have failed to achieve seizure control with at least two appropriate antiseizure medications (ASM) based on the 2009 ILAE definition of drug resistant epilepsy * Current treatment with at least 1 ASM with stable doses for at least three months Exclusion Criteria: * Any condition that would impact a subject's ability to follow study procedures or subject's safety * History of significant adverse reactions to electrical stimulation (e.g. TEMS device) * Subjects with only focal aware nonmotor seizures * Women of childbearing age, pregnant or breastfeeding * Implanted cardiac pacemaker or implanted/wearable defibrillator or implanted metallic device in head

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Conditions

The condition(s) this trial relates to.

epilepsy

As listed by the trial registrant

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

Epilepsy (treatment refractory)

Contacts and locations

Locations

  • Debakey VA Medical Center

    Houston, Texas, 77080, United States

More trials for these conditions

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