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External Trigeminal Nerve Stimulation for Epilepsy

NCT01159431 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-06-03

Study results available
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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.

Conditions

Interventions

DEVICE

Trigeminal Nerve Stimulation

External stimulation of the supraorbital branch of the Trigeminal Nerve using a digital TENs unit

Sponsors & Collaborators

  • Epilepsy Foundation

    collaborator OTHER

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Olive View-UCLA Education & Research Institute

    lead OTHER

Principal Investigators

  • Christopher M DeGiorgio, MD · University of California, Los Angeles

  • Christi Heck, MD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01159431 on ClinicalTrials.gov