Clinical trial NCT01159431: External Trigeminal Nerve Stimulation for Epilepsy
Official title: Randomized Double Blind Study of External Trigeminal Nerve Stimulation for Intractable Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Seizure Disorders
Keywords: partial seizures
poorly controlled epilepsy
intractable epilepsy
treatment resistant epilepsy
Trigeminal Nerve
Trigeminal Nerve Stimulation
Lead sponsor: Olive View-UCLA Education & Research Institute
Sponsor class: OTHER
Collaborators: name: Epilepsy Foundation
name: Boston Scientific Corporation
First posted: 2010-07-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 50% Responder Rate
timeFrame: Treatment period, 18 weeks (end of double blind period) compared with first 6 weeks
measure: Time to the 4th Seizure
timeFrame: treatment period (18-weeks)
measure: Change in Seizure Frequency
timeFrame: 18 weeks
Secondary outcomes:
measure: Response Ratio: Mean Percent Change in Seizures
timeFrame: 18 weeks
measure: Mood
timeFrame: 18-weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Department of Neurology
state: California
city: Sylmar
country: United States
facility: Olive View/UCLA Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Christopher M DeGiorgio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Christi Heck, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.