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| Name | Class |
|---|---|
| Olive View-UCLA Education & Research Institute | OTHER |
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The purpose of this study is to evaluate the tolerability and safety of the NeuroSigma eTNS system.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Trigeminal nerve stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External Trigeminal Nerve Stimulation (eTNS) | Device | External stimulation of the trigeminal nerve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of eTNS | Number and percent of subjects with adverse events related to the device at four weeks. | Four weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Olive View/UCLA Medical Center | Sylmar | California | United States |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |