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

NCT04770337 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Neuroelectrics Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-25
Primary Completion
2026-01-12
Completion
2026-01-12
FDA Device
Yes

Countries

  • United States
  • Belgium
  • France
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04770337 on ClinicalTrials.gov