Trigeminal Nerve Stimulation of the Treatment of Epilepsy (NCT07220161) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Trigeminal Nerve Stimulation of the Treatment of Epilepsy
United States24 participantsStarted 2025-05-08
Plain-language summary
Background: Epilepsy is a common neurological disorder among veterans. Medications do not control seizures in 1/3rd of patients, who often require neurostimulation. However, current neurostimulation devices are invasive. Objective: The investigators propose a novel clinical trial to repurpose the FDA-approved Cefaly device, designed for migraine relief, to treat epilepsy. The Cefaly device works by non-invasive Trigeminal neurostimulation (TNS). TNS has previously shown promising preliminary results in seizure improvement. Design: The investigators will engage 24 veterans with drug-resistant epilepsy, half of whom will receive standard care, while the other half will receive standard care plus Cefaly. This will be followed by a crossover of the treatment/control groups. The primary objective is to evaluate seizure frequency improvement over 12 months.
Who can participate
Age range
18 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.