Trigeminal Nerve Stimulation of the Treatment of Epilepsy

NCT ID: NCT07220161

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-08
• Study Completion Date: 2026-06-30

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)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment with Trigeminal Nerve Stimulation

Treatment with trigeminal nerve stimulation x 6 months

Group Type: EXPERIMENTAL

Trigeminal nerve stimulation

Intervention Type: 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.

Control

Standard care x 6 months

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Michael E. DeBakey VA Medical Center

FED

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Hina Dave

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hina Dave, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine/Debakey VA Medical Center

Locations

Debakey VA Medical Center

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24289825 (View on PubMed)

Other Identifiers

H-55827

Identifier Type: -

Identifier Source: org_study_id