Safety and Therapeutic Measures of Transcranial Cathodal Direct Current Stimulation (TDCS) in Patients with Refractory Focal Epilepsy (Starstim, NE001)

Purpose

This study is a randomized, sham-controlled, double-blinded, multi-center study, followed by optional open-label extension (OLE).

The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions of transcranial cathodal direct current stimulation (tDCS).

Who can participate

Adults 18 years and older with focal onset seizures, refractory to medical management, defined on the basis of presence of focal spikes and (if available) focal seizure onsets originating from the lateral cortical surface of any lobe, or from mesial temporal lobe are eligible for enrollment in the study.

Visits

Patients can expect a total of 15 visits over a period of 7 months.