Status:
ACTIVE_NOT_RECRUITING
Trigeminal Nerve Stimulation of the Treatment of Epilepsy
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Michael E. DeBakey VA Medical Center
Conditions:
Epilepsy (Treatment Refractory)
Eligibility:
MALE
18-65 years
Phase:
NA
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07220161
Start Date
May 8 2025
End Date
June 30 2026
Last Update
October 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Debakey VA Medical Center
Houston, Texas, United States, 77080