External Trigeminal Nerve Stimulation for Epilepsy

Epilepsy Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Seizure Disorders

• NCT number: NCT01159431
• Study type: Interventional
• Source: Olive View-UCLA Education & Research Institute
• Status: Completed
• Phase: Phase 2
• Start date: January 2008
• Completion date: June 2011