External Trigeminal Nerve Stimulation for Drug Resistent Epilepsy (eTNS for DRE)

April 11, 2016 updated by: NeuroSigma, Inc.

External Trigeminal Nerve Stimulation for Epilepsy

The purpose of this study is to evaluate the tolerability and safety of the NeuroSigma eTNS system.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study evaluates the safety and tolerability of the NeuroSigma eTNS system for the treatment of drug resistent partial seizures.

Up to 20 subjects, ages 18 - 75, with partial epilepsy will be enrolled in an acute 4-week tolerability study at Olive View/UCLA Medical Center .......

Enrolled subjects will be asked to maintain an accurate seizure calendar, and will be seen at the initial visit, then at two and four weeks.......

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sylmar, California, United States
        • Olive View/Ucla Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-65
  • Partial onset seizures (complex partial or secondary generalized tonic-clonic)
  • At least one seizure every three months
  • No serious or progressive medical or psychiatric illness
  • At least one complex partial or generalized tonic-clonic seizure in the last three months
  • MRI or EEG consistent with localization-related or partial epilepsy
  • Exposure to at least two anti-epileptic drugs at adequate doses
  • Concurrent use of at least one anti-epileptic drug at adequate doses
  • No change in anti-epileptic drug dose for at least 30 days prior to study enrollment

Exclusion Criteria:

  • Vagus nerve stimulation (VNS)
  • History of non-epileptic seizures
  • Inability to maintain accurate seizure calendars (self or caregiver)
  • Frequent use of benzodiazepines for seizure clusters defined as greater that four times per month
  • History of facial pain or trigeminal neuralgia
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Active
Trigeminal nerve stimulation
Device: External Trigeminal Nerve Stimulation (eTNS)
External stimulation of the trigeminal nerve.
Other Names:
  • eTNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of eTNS
Time Frame: Four weeks
Number and percent of subjects with adverse events related to the device at four weeks.
Four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory
Time Frame: Four weeks
Percentage change in Beck Depression Inventory score at four weeks compared to initial visit.
Four weeks
Quality of Life
Time Frame: Four weeks
Absolute change in QOLIE-31 (Quality of Life in Epilepsy) Inventory scale and sub-scales at four weeks.
Four weeks
Systolic Blood Pressure and Heart Rate
Time Frame: Four weeks
Absolute and percent change in systolic blood pressure and heart rate at four weeks compared to initial visit.
Four weeks
Skin Irritation
Time Frame: Four weeks
Number and percentage of subjects with skin irritation > 1 on a standardized scale.
Four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuroSigma, Inc.

Collaborators

Olive View-UCLA Education & Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ANTICIPATED)

June 1, 2016

Study Completion (ANTICIPATED)

August 1, 2016

Study Registration Dates

First Submitted

November 1, 2013

First Submitted That Met QC Criteria

November 1, 2013

First Posted (ESTIMATE)

November 7, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 13, 2016

Last Update Submitted That Met QC Criteria

April 11, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NS-076014-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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