External Trigeminal Nerve Stimulation for Epilepsy

Completed · Phase 2

Conditions studied: Epilepsy, Seizure Disorders

In brief

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. The purpose of this study is to determine if TNS is safe and effective using a rigorous randomized active-control clinical trial design in 50 people with epilepsy.

Key facts

Study ID

NCT01159431

Run by

Olive View-UCLA Education & Research Institute

People needed

50

Starts

2008-01-01

Expected to finish

2011-06-01

Last updated by the study team

2013-06-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• USC Department of Neurology — Los Angeles, California, United States
• Olive View/UCLA Medical Center — Sylmar, California, United States

Full record on ClinicalTrials.gov

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