Overview

This trial is active, not recruiting.

Condition seizure disorder
Treatment external trigeminal nerve stimulation (etns)
Sponsor NeuroSigma, Inc.
Collaborator Olive View-UCLA Education & Research Institute
Start date June 2012
End date June 2016
Trial size 20 participants
Trial identifier NCT01978470, NCT01607567, NS-076014-01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
Trigeminal nerve stimulation
external trigeminal nerve stimulation (etns) eTNS
External stimulation of the trigeminal nerve.

Primary Outcomes

Measure
Safety of eTNS
time frame: Four weeks

Secondary Outcomes

Measure
Beck Depression Inventory
time frame: Four weeks
Quality of Life
time frame: Four weeks
Systolic Blood Pressure and Heart Rate
time frame: Four weeks
Skin Irritation
time frame: Four weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title External Trigeminal Nerve Stimulation for Epilepsy
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.......
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by NeuroSigma, Inc..