Trigeminal Nerve Stimulation of the Treatment of Epilepsy

NCT07220161 | Active Not Recruiting FDA Device

• 1 other identifier: H-55827
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy (Treatment Refractory)

Outcome Measures

Primary Outcomes (1)

• Seizure frequency

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

  6 months

Secondary Outcomes (2)

• QOLIE-31

  6 months

• Beck Depression Inventory

  6 months

Study Arms (2)

Treatment with Trigeminal Nerve Stimulation

EXPERIMENTAL

Treatment with trigeminal nerve stimulation x 6 months

Device: Trigeminal nerve stimulation

Control

NO INTERVENTION

Standard care x 6 months

Interventions

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.

Treatment with Trigeminal Nerve Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Michael E. DeBakey VA Medical Center: collaborator

Study Sites (1)

Debakey VA Medical Center

Houston, Texas, 77080, United States

Location

Related Publications (1)

• Magis D, Sava S, d'Elia TS, Baschi R, Schoenen J. Safety and patients' satisfaction of transcutaneous supraorbital neurostimulation (tSNS) with the Cefaly(R) device in headache treatment: a survey of 2,313 headache sufferers in the general population. J Headache Pain. 2013 Dec 1;14(1):95. doi: 10.1186/1129-2377-14-95.

  PMID: 24289825 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Hina Dave, MD

  Baylor College of Medicine/Debakey VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: There are no parties who are masked.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Cefaly Connected

Study Record Dates

• First Submitted: October 21, 2025
• First Posted: October 23, 2025
• Study Start: May 8, 2025
• Primary Completion (Estimated): May 8, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)