Seizure Disorder
Conditions
Keywords
epilepsy, drug resistent epilepsy, partial onset seizures, trigeminal nerve stimulation, neuromodulation
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.......
Interventions
DEVICEExternal Trigeminal Nerve Stimulation (eTNS)
External stimulation of the trigeminal nerve.
Sponsors
Olive View-UCLA Education & Research Institute
NeuroSigma, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of eTNS | Four weeks | Number and percent of subjects with adverse events related to the device at four weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed