An interventional study of Trigeminal nerve stimulation in Epilepsy (Treatment Refractory), sponsored by Baylor College of Medicine. Active, not recruiting at 1 site in United States. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-10-23.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
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.
1,804 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's planned enrollment of 24 is below the median of 50 across 1,205 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment with trigeminal nerve stimulation x 6 months
Device: Trigeminal nerve stimulation
Standard care x 6 months
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.
Seizure frequency
The primary outcome will be the reduction in seizure frequency with the treatment device compared to baseline measurements.
Time frame: 6 months
QOLIE-31
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.
Time frame: 6 months
Beck Depression Inventory
Mood will be followed with the Beck Depression Inventory.
Time frame: 6 months
Plan to share: No
This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Baylor College of Medicine