NCT07220161Active, not recruiting
Trigeminal Nerve Stimulation of the Treatment of Epilepsy
Innovative Repurposing of Trigeminal Nerve Stimulation of the Treatment of Epilepsy in Veterans
Source: ClinicalTrials.gov · Last updated 23 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 21 Oct 2025
- Start date
- 8 May 2025
- Primary completion date
- 8 May 2026
- Lead sponsor
- Baylor College of Medicine
- Diseases
- Epilepsy
- NCT number
- NCT07220161
What you commit to
- Study type: Interventional
- Planned participants: 24
- From 8 May 2025 to the primary completion date, 8 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Implanted cardiac pacemaker or implanted/wearable defibrillator or implanted metallic device in head
Age
- Women of childbearing age, pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Debakey VA Medical Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.