Sylmar, California 91342

  • Seizure Disorder

Purpose:

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


Study summary:

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.


Criteria:

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


NCT ID:

NCT01607567


Primary Contact:

Principal Investigator
Christopher DeGiorgio, MD
University of California, Los Angeles

Diana Murray
Phone: 818-364-3104


Backup Contact:

N/A


Location Contact:

Sylmar, California 91342
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 16, 2021

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