NCT04770337

Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy

STARSTIM: SAFETY AND THERAPEUTIC MEASURES OF TRANSCRANIAL CATHODAL DIRECT CURRENT STIMULATION (TDCS) IN PATIENTS WITH REFRACTORY FOCAL EPILEPSY

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Neuroelectrics Corporation · Industry
• Sex: All
• Age: 9 Years
• Healthy volunteers: Not accepted

Summary

This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial cathodal direct current stimulation (tDCS). Subjects will be treated with STARTSTIM or sham device for 10 sessions over a 2-week period. The subjects will be followed for an additional 10 weeks post treatment. Quality of Life questionnaires and adverse events will be collected and evaluated.

Detailed description

Study design is an evaluation of the STARSTIM device (tDCS) in subjects over 9 years of age, diagnosed with epilepsy with focal seizures with or without focal to bilateral tonic clonic seizures. Seizure diaries will be collected for 12 weeks to establish a rate of seizure for each subject prior to treatment. Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment. Neither the study investigator nor subject shall be notified of the treatment assignment. Treatment will be done daily at the investigator's site for 10 days. A Seizure Diary will be maintained through the course of the treatment and the follow up period. Subjects will have 3 follow up visits to evaluate their seizure rate, adverse events, medications and quality of life. A Data Safety Monitoring Board will be utilized to evaluate safety events through study milestones. Seizure frequency rates pre, during and post treatment will be evaluated for both the active and sham treatment arms.

Conditions

• Refractory Epilepsy
• Focal Seizure
• Seizures, Focal
• Seizures
• Epilepsy in Children
• Epilepsy
• Epilepsy, Tonic-Clonic

Interventions

Type	Name	Description
DEVICE	STARSTIM device	Cathodal Transcranial Direct Current Stimulation (tDCS). Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered to the brain area of interest via electrodes on the scalp.
DEVICE	Sham Device	Intervention which uses enough currents to generate a sensory feedback similar to that of active stimulation via electrodes on the scalp

Timeline

• Start date: 2021-10-25
• Primary completion: 2026-01-12
• Completion: 2026-01-12
• First posted: 2021-02-25
• Last updated: 2026-04-08

Locations

32 sites across 4 countries: United States, Belgium, France, Spain

Regulatory

• FDA-regulated device study