Trigeminal Nerve Stimulation of the Treatment of Epilepsy

Baylor College of Medicine

Status: Active, not recruiting

Conditions: Epilepsy (Treatment Refractory)

Treatments: Device: Trigeminal nerve stimulation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07220161

H-55827

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Treatment with Trigeminal Nerve Stimulation

Experimental group

Description:

Treatment with trigeminal nerve stimulation x 6 months

Treatment:

Device: Trigeminal nerve stimulation

Control

No Intervention group

Description:

Standard care x 6 months