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Completed

NCT Number: NCT01159431

External Trigeminal Nerve Stimulation for Epilepsy

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizure Disorders Seizures Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

USC Department of Neurology, Los Angeles, California, United States

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About this study

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:

  • Percent change in seizure frequency during the treatment period compared with the baseline (pre-treatment) period.
  • Time to the 4th seizure

The primary comparisons will be between and within groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trigeminal Nerve Stimulation

Device

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

Primary outcomes

  1. 50% Responder Rate

    Time frame: Treatment period, 18 weeks (end of double blind period) compared with first 6 weeks

    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.

  2. Time to the 4th Seizure

    Time frame: treatment period (18-weeks)

    Number of Days to the 4th seizure

  3. Change in Seizure Frequency

    Time frame: 18 weeks

    Percent change in seizure frequency from baseline

Secondary outcomes

  1. Response Ratio: Mean Percent Change in Seizures

    Time frame: 18 weeks

    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.

  2. Mood

    Time frame: 18-weeks

    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.

Sponsors and collaborators

Lead sponsor

Olive View-UCLA Education & Research Institute

Other

Collaborators

  • Boston Scientific Corporation
  • Epilepsy Foundation

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 9, 2010
Registry last updated
Jun 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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