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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01978470
Recruitment Status : Unknown
Verified April 2016 by NeuroSigma, Inc..
Recruitment status was:  Active, not recruiting
First Posted : November 7, 2013
Last Update Posted : April 13, 2016
Sponsor:
Collaborator:
Olive View-UCLA Education & Research Institute
Information provided by (Responsible Party):
NeuroSigma, Inc.

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

Condition or disease Intervention/treatment Phase
Seizure Disorder Device: External Trigeminal Nerve Stimulation (eTNS) Not Applicable

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.......


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: External Trigeminal Nerve Stimulation for Epilepsy
Study Start Date : June 2012
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
Experimental: Active
Trigeminal nerve stimulation
Device: External Trigeminal Nerve Stimulation (eTNS)
External stimulation of the trigeminal nerve.
Other Name: eTNS




Primary Outcome Measures :
  1. Safety of eTNS [ Time Frame: Four weeks ]
    Number and percent of subjects with adverse events related to the device at four weeks.


Secondary Outcome Measures :
  1. Beck Depression Inventory [ Time Frame: Four weeks ]
    Percentage change in Beck Depression Inventory score at four weeks compared to initial visit.

  2. 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.

  3. 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.

  4. Skin Irritation [ Time Frame: Four weeks ]
    Number and percentage of subjects with skin irritation > 1 on a standardized scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978470


Locations
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United States, California
Olive View/UCLA Medical Center
Sylmar, California, United States
Sponsors and Collaborators
NeuroSigma, Inc.
Olive View-UCLA Education & Research Institute

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Responsible Party: NeuroSigma, Inc.
ClinicalTrials.gov Identifier: NCT01978470     History of Changes
Obsolete Identifiers: NCT01607567
Other Study ID Numbers: NS-076014-01
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016

Keywords provided by NeuroSigma, Inc.:
epilepsy
drug resistent epilepsy
partial onset seizures
trigeminal nerve stimulation
neuromodulation

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