NCT01159431

External Trigeminal Nerve Stimulation for Epilepsy

Randomized Double Blind Study of External Trigeminal Nerve Stimulation for Intractable Epilepsy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Olive View-UCLA Education & Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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. 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.

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 resective surgical candidates. Trigeminal Nerve Stimulation (TNS) is a novel form of neurostimulation, and has a strong antiepileptic effect in an animal model of seizures. Preliminary data in humans indicates TNS is well tolerated and may be effective in people with intractable epilepsy. TNS is an alternative mode of neurostimulation, because the Trigeminal Nerve can be stimulated in minimally-invasive fashion. This is a randomized double blind study of Trigeminal Nerve Stimulation, which compares high stimulation to an active control. Subjects with poorly controlled partial onset seizures who meet all inclusion and exclusion criteria, enter a 6-week baseline period, and then are randomized in double-blind fashion to high or low intensity stimulation for 18 weeks. 50 subjects are to be enrolled at two sites. Study outcomes are the following: 1. Percent change in seizure frequency during the treatment period compared with the baseline (pre-treatment) period. 2. Time to the 4th seizure The primary comparisons will be between and within groups.

Conditions

• Epilepsy
• Seizure Disorders

Interventions

Type	Name	Description
DEVICE	Trigeminal Nerve Stimulation	External stimulation of the supraorbital branch of the Trigeminal Nerve using a digital TENs unit

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-07-09
• Last updated: 2013-06-03
• Results posted: 2013-06-03

Locations

2 sites across 1 country: United States