NCT07220161

Trigeminal Nerve Stimulation of the Treatment of Epilepsy

Innovative Repurposing of Trigeminal Nerve Stimulation of the Treatment of Epilepsy in Veterans

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy (Treatment Refractory)

Interventions

Type	Name	Description
DEVICE	Trigeminal nerve stimulation	The study device, "Cefaly® Connected", is a non-invasive neuromodulation tool designed for the prevention and treatment of migraine headaches. It works by delivering transcutaneous electrical stimulation to the bilateral supraorbital nerves, which are branches of the trigeminal nerve. The device is placed on the forehead, and it emits electrical impulses that modulate the activity of the trigeminal nerve.

Timeline

• Start date: 2025-05-08
• Primary completion: 2026-05-08
• Completion: 2026-06-30
• First posted: 2025-10-23
• Last updated: 2025-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study