Trigeminal Nerve Stimulation of the Treatment of Epilepsy

Not Applicable

Active, not recruiting

• Conditions: Epilepsy (Treatment Refractory)

• Registration Number: NCT07220161
• Lead Sponsor: Baylor College of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-08
• Status Verified: 2025-10
• Study First Submitted: 2025-10-21
• Study First Submitted QC: 2025-10-21
• Last Update Submitted: 2025-10-21
• Study First Posted: 2025-10-23
• Last Update Posted: 2025-10-23
• Primary Completion: 2026-05-08
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Seizure frequency	6 months	The primary outcome will be the reduction in seizure frequency with the treatment device compared to baseline measurements.

Secondary Outcome Measures

Name	Time	Method
Beck Depression Inventory	6 months	Mood will be followed with the Beck Depression Inventory.
QOLIE-31	6 months	Improvement in quality of life as a secondary outcome with a focus on daily functionality, mental health, and overall subject well-being. This will be collected through the QOLIE-31.

Trial Locations

Locations (1)

Debakey VA Medical Center; 🇺🇸 Houston, Texas, United States