External Trigeminal Nerve Stimulation for Epilepsy

NCT ID: NCT01159431

Last Updated: 2013-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-06-30

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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active

Group Type: EXPERIMENTAL

Trigeminal Nerve Stimulation

Intervention Type: DEVICE

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

Control

Group Type: OTHER

Trigeminal Nerve Stimulation

Intervention Type: DEVICE

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

Interventions

Trigeminal Nerve Stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Epilepsy Foundation

OTHER

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Olive View-UCLA Education & Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Christopher DeGiorgio

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher M DeGiorgio, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Christi Heck, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

USC Department of Neurology

Los Angeles, California, United States

Olive View/UCLA Medical Center

Sylmar, California, United States

Countries

United States

References

DeGiorgio CM, Murray D, Markovic D, Whitehurst T. Trigeminal nerve stimulation for epilepsy: long-term feasibility and efficacy. Neurology. 2009 Mar 10;72(10):936-8. doi: 10.1212/01.wnl.0000344181.97126.b4. No abstract available.

Reference Type: BACKGROUND

PMID: 19273830 (View on PubMed)

DeGiorgio CM, Soss J, Cook IA, Markovic D, Gornbein J, Murray D, Oviedo S, Gordon S, Corralle-Leyva G, Kealey CP, Heck CN. Randomized controlled trial of trigeminal nerve stimulation for drug-resistant epilepsy. Neurology. 2013 Feb 26;80(9):786-91. doi: 10.1212/WNL.0b013e318285c11a. Epub 2013 Jan 30.

Reference Type: RESULT

PMID: 23365066 (View on PubMed)

Other Identifiers

TNS-TDP-01

Identifier Type: -

Identifier Source: org_study_id