External Trigeminal Nerve Stimulation for Drug Resistent Epilepsy

Status unconfirmed · Not applicable

Conditions studied: Seizure Disorder

In brief

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

Key facts

Study ID

NCT01978470

Run by

NeuroSigma, Inc.

People needed

20

Starts

2012-06-01

Expected to finish

2016-08-01

Last updated by the study team

2016-04-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Olive View/UCLA Medical Center — Sylmar, California, United States

Full record on ClinicalTrials.gov

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