Status:
COMPLETED
External Trigeminal Nerve Stimulation for Epilepsy
Lead Sponsor:
Olive View-UCLA Education & Research Institute
Collaborating Sponsors:
Epilepsy Foundation
Boston Scientific Corporation
Conditions:
Epilepsy
Seizure Disorders
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study investigates a new therapy for epilepsy called Trigeminal Nerve Stimulation (TNS). TNS involves external electrical stimulation of sensory nerve located above the eyes and over the forehead...
Detailed Description
Poorly controlled epilepsy is a disabling condition, affecting over one million Americans. Neurostimulation is a promising alternative for patients who have failed medical therapy, and who are not res...
Eligibility Criteria
Inclusion
- Ages 18 - 70;
- No serious or progressive medical illness;
- A history of intractable partial seizures;
- At least two complex partial or tonic clonic generalized seizures per month in the last two consecutive months;
- MRI or EEG consistent with localization-related or partial epilepsy;
- Exposure to at least two antiepileptic drugs at adequate doses;
- Concurrent use of at least one antiepileptic drug at adequate doses;
- No change in antiepileptic dose for at least 30 days before study enrollment
Exclusion
- History of non-epileptic seizures;
- Inability to maintain accurate seizure calendars (self or caregiver);
- Frequent use of benzodiazepines for clusters defined as greater than four times a month;
- History of facial pain or trigeminal neuralgia;
- Concurrent vagus nerve stimulation;
- Pregnancy
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01159431
Start Date
January 1 2008
End Date
June 1 2011
Last Update
June 3 2013
Active Locations (2)
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1
USC Department of Neurology
Los Angeles, California, United States, 90033
2
Olive View/UCLA Medical Center
Sylmar, California, United States, 91342