Trigeminal Nerve Stimulation of the Treatment of Epilepsy

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.

NCT Number	NCT07220161
Lead Sponsor	Baylor College of Medicine Collaborators: Michael E. DeBakey VA Medical Center
Conditions	Epilepsy (Treatment Refractory)
Enrollment	24 participants
Start Date	2025-05-08
Primary Completion	2026-05-08 (estimated)
Study Completion	2026-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-10-23