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.......
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
20
External stimulation of the trigeminal nerve.
Olive View/UCLA Medical Center
Sylmar, California, United States
Safety of eTNS
Number and percent of subjects with adverse events related to the device at four weeks.
Time frame: Four weeks
Beck Depression Inventory
Percentage change in Beck Depression Inventory score at four weeks compared to initial visit.
Time frame: Four weeks
Quality of Life
Absolute change in QOLIE-31 (Quality of Life in Epilepsy) Inventory scale and sub-scales at four weeks.
Time frame: 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.
Time frame: Four weeks
Skin Irritation
Number and percentage of subjects with skin irritation \> 1 on a standardized scale.
Time frame: Four weeks
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