Randomized controlled trial of trigeminal nerve stimulation for drug-resistant epilepsy.

ABSTRACT:

Objective

To explore the safety and efficacy of external trigeminal nerve stimulation (eTNS) in patients with drug-resistant epilepsy (DRE) using a double-blind randomized controlled trial design, and to test the suitability of treatment and control parameters in preparation for a phase III multicenter clinical trial.

Methods

This is a double-blind randomized active-control trial in DRE. Fifty subjects with 2 or more partial onset seizures per month (complex partial or tonic-clonic) entered a 6-week baseline period, and then were evaluated at 6, 12, and 18 weeks during the acute treatment period. Subjects were randomized to treatment (eTNS 120 Hz) or control (eTNS 2 Hz) parameters.

Results

At entry, subjects were highly drug-resistant, averaging 8.7 seizures per month

SUBMITTER: DeGiorgio CM 

PROVIDER: S-EPMC3598453 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature