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External Trigeminal Nerve Stimulation for Epilepsy

This study has been completed.
Sponsor:
Collaborators:
Epilepsy Foundation
Boston Scientific Corporation
Information provided by (Responsible Party):
Christopher DeGiorgio, Olive View-UCLA Education & Research Institute
ClinicalTrials.gov Identifier:
NCT01159431
First received: July 7, 2010
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Epilepsy
Seizure Disorders
Device: Trigeminal Nerve Stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double Blind Study of External Trigeminal Nerve Stimulation for Intractable Epilepsy

Resource links provided by NLM:


Further study details as provided by Olive View-UCLA Education & Research Institute:

Primary Outcome Measures:
  • 50% Responder Rate [ Time Frame: Treatment period, 18 weeks (end of double blind period) compared with first 6 weeks ] [ Designated as safety issue: No ]

    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.


  • Time to the 4th Seizure [ Time Frame: treatment period (18-weeks) ] [ Designated as safety issue: No ]
    Number of Days to the 4th seizure

  • Change in Seizure Frequency [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    Percent change in seizure frequency from baseline


Secondary Outcome Measures:
  • Response Ratio: Mean Percent Change in Seizures [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    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.

  • Mood [ Time Frame: 18-weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: January 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Device: Trigeminal Nerve Stimulation
External stimulation of the supraorbital branch of the Trigeminal Nerve using a digital TENs unit
Control Device: Trigeminal Nerve Stimulation
External stimulation of the supraorbital branch of the Trigeminal Nerve using a digital TENs unit

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159431

Locations
United States, California
USC Department of Neurology
Los Angeles, California, United States, 90033
Olive View/UCLA Medical Center
Sylmar, California, United States, 91342
Sponsors and Collaborators
Olive View-UCLA Education & Research Institute
Epilepsy Foundation
Boston Scientific Corporation
Investigators
Principal Investigator: Christopher M DeGiorgio, MD UCLA Department of Neurology
Principal Investigator: Christi Heck, MD University of Southern California
  More Information

Publications:
Responsible Party: Christopher DeGiorgio, PI, Olive View-UCLA Education & Research Institute
ClinicalTrials.gov Identifier: NCT01159431     History of Changes
Other Study ID Numbers: TNS-TDP-01
Study First Received: July 7, 2010
Results First Received: February 1, 2013
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Olive View-UCLA Education & Research Institute:
partial seizures
poorly controlled epilepsy
intractable epilepsy
treatment resistant epilepsy
Trigeminal Nerve
Trigeminal Nerve Stimulation

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014