Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07220161

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Epilepsy (treatment Refractory) Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Debakey VA Medical Center

Houston, Texas, 77080, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trigeminal Nerve Stimulation

Device

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.

Primary outcomes

  1. Seizure frequency

    Time frame: 6 months

    The primary outcome will be the reduction in seizure frequency with the treatment device compared to baseline measurements.

Secondary outcomes

  1. QOLIE-31

    Time frame: 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.

  2. Beck Depression Inventory

    Time frame: 6 months

    Mood will be followed with the Beck Depression Inventory.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Michael E. DeBakey VA Medical Center

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2025
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.