Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-29 @ 3:10 AM
Study NCT ID:
NCT07220161
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-23
First Post:
2025-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trigeminal Nerve Stimulation of the Treatment of Epilepsy
Sponsor:
Baylor College of Medicine
Organization:
Study Overview
Official Title:
Innovative Repurposing of Trigeminal Nerve Stimulation of the Treatment of Epilepsy in Veterans
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: