Trigeminal Nerve Stimulation for Drug Resistant Epilepsy

This study evaluates the safety, and tolerability of the NeuroSigma eTNS(TM) system for the
treatment of drug resistant partial seizures.

Up to 20 subjects ages 18 - 65 with partial epilepsy will be enrolled in a acute 4-week
feasibility study at Olive View/UCLA Medical Center. Subjects will be screened for
eligibility, and if eligible will undergo informed consent.

Enrolled subjects will be asked to maintain an accurate seizure calendar, and will been seen
at the initial visit, then at two and four weeks. Subjects will undergo initial stimulation
with the NeuroSigma eTNS Trigeminal Nerve Stimulation System, and the following assessments
will be performed: Stimulus response measurements, vital signs, cognitive and mood testing,
brief physical exam, and intraocular pressure. The initial study lasts four weeks, and if
subjects and the study physician agree, subjects may continue in long-term followup and
return for evaluation every 3-months.

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 tonic-clonic generalized seizures in the last three
consecutive months;

- MRI or EEG consistent with localization-related or partial epilepsy;

- Exposure to at least two antiepileptic drugs at adequate doses;

- Concurrent use of at least one antiepileptic drug at adequate doses;

- No change in antiepileptic dose for at least 30 days before study enrollment

Exclusion Criteria:

- Vagus nerve stimulation;

- History of non-epileptic seizures;

- Inability to maintain accurate seizure calendars (self or caregiver);

- Frequent use of benzodiazepines for clusters defined as greater than four times a
month;

- History of facial pain or trigeminal neuralgia;

- Pregnancy