External Trigeminal Nerve Stimulation for Drug Resistent Epilepsy

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

Detailed Description
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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.......

Official Title
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External Trigeminal Nerve Stimulation for Epilepsy

Conditions
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Seizure Disorder

Intervention / Treatment
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* Device: External Trigeminal Nerve Stimulation (eTNS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Trigeminal nerve stimulation | Device: External Trigeminal Nerve Stimulation (eTNS)<br>* External stimulation of the trigeminal nerve.<br>* Other names: eTNS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of eTNS | 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 | Percentage change in Beck Depression Inventory score at four weeks compared to initial visit. | Four weeks | 
| Quality of Life | 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 | Absolute and percent change in systolic blood pressure and heart rate at four weeks compared to initial visit. | Four weeks | 
| Skin Irritation | Number and percentage of subjects with skin irritation > 1 on a standardized scale. | Four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epilepsy, drug resistent epilepsy, partial onset seizures, trigeminal nerve stimulation, neuromodulation