External Trigeminal Nerve Stimulation for Drug Resistent Epilepsy (eTNS for DRE)
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|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
|Condition or disease||Intervention/treatment||Phase|
|Seizure Disorder||Device: External Trigeminal Nerve Stimulation (eTNS)||Not Applicable|
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 (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|
Trigeminal nerve stimulation
Device: External Trigeminal Nerve Stimulation (eTNS)
External stimulation of the trigeminal nerve.
Other Name: eTNS
- Safety of eTNS [ Time Frame: Four weeks ]Number and percent of subjects with adverse events related to the device at four weeks.
- Beck Depression Inventory [ Time Frame: Four weeks ]Percentage change in Beck Depression Inventory score at four weeks compared to initial visit.
- 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.
- 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.
- Skin Irritation [ Time Frame: Four weeks ]Number and percentage of subjects with skin irritation > 1 on a standardized scale.
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
|United States, California|
|Olive View/UCLA Medical Center|
|Sylmar, California, United States|