External Trigeminal Nerve Stimulation for Epilepsy

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159431
• Other study ID #: TNS-TDP-01
• Status: Completed
• Phase: Phase 2
• First received: July 7, 2010
• Last updated: May 6, 2013
• Start date: January 2008
• Est. completion date: June 2011

Study information

• Verified date: May 2013
• Source: Olive View-UCLA Education & Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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

Intervention

Device:
• Trigeminal Nerve Stimulation
External stimulation of the supraorbital branch of the Trigeminal Nerve using a digital TENs unit

Locations

Country	Name	City	State
United States	USC Department of Neurology	Los Angeles	California
United States	Olive View/UCLA Medical Center	Sylmar	California

Sponsors (3)

Lead Sponsor	Collaborator
Olive View-UCLA Education & Research Institute	Boston Scientific Corporation, Epilepsy Foundation

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	50% Responder Rate	Change in responder rate, at end of study (18 weeks); Absolute percent of subjects with 50% reduction in seizures, 18 weeks compared with 6 weeks Note, the number is not a mean or median, but a fixed percentage.	Treatment period, 18 weeks (end of double blind period) compared with first 6 weeks	No
Primary	Time to the 4th Seizure	Number of Days to the 4th seizure	treatment period (18-weeks)	No
Primary	Change in Seizure Frequency	Percent change in seizure frequency from baseline	18 weeks	No
Secondary	Response Ratio: Mean Percent Change in Seizures	Response Ratio: Mean Percent Change in seizures over the treatment period, where [T-B] / [T+B] x 100%, where T = seizure frequency during the treatment period, and B = seizure frequency during the baseline period.	18 weeks	No
Secondary	Mood	Mean change in score on the Beck Depression Inventory. The Beck Inventory is a patient reported mood scale. The minimum score is 0, and the maximum score is 63. Scores of less than 10 are considered in the normal range. Scores above 10 are consistent with depression. Higher scores indicate higher degrees of depression, with scores of > 25 consistent with severe depression.	18-weeks	No