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Trigeminal Nerve Stimulation of the Treatment of Epilepsy

NCT07220161 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-10-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Michael E. DeBakey VA Medical Center

    collaborator FED

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Hina Dave, MD · Baylor College of Medicine/Debakey VA Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-08
Primary Completion
2026-05-08
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07220161 on ClinicalTrials.gov