External Trigeminal Nerve Stimulation for Drug Resistent Epilepsy

Not Applicable

• Conditions: Seizure Disorder
• Interventions: Device: External Trigeminal Nerve Stimulation (eTNS)

• Registration Number: NCT01978470
• Lead Sponsor: NeuroSigma, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-07
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-11
• Last Update Posted: 2016-04-13
• Primary Completion: 2016-06
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	External Trigeminal Nerve Stimulation (eTNS)	Trigeminal nerve stimulation

Primary Outcome Measures

Name	Time	Method
Safety of eTNS	Four weeks	Number and percent of subjects with adverse events related to the device at four weeks.

Secondary Outcome Measures

Name	Time	Method
Beck Depression Inventory	Four weeks	Percentage change in Beck Depression Inventory score at four weeks compared to initial visit.
Quality of Life	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	Four weeks	Absolute and percent change in systolic blood pressure and heart rate at four weeks compared to initial visit.
Skin Irritation	Four weeks	Number and percentage of subjects with skin irritation \> 1 on a standardized scale.

Trial Locations

Locations (1)

Olive View/UCLA Medical Center; 🇺🇸 Sylmar, California, United States