CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 22 enrolled
Drug / intervention
tDCSdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02731300
NCT02731300Phase 4Completed

Transcranial Direct Current Stimulation for Treatment of Childhood Pharmacoresistant Lennox-Gastaut Syndrome, A Pilot Study

Khon Kaen University·interventional·Posted Apr 7, 2016·Updated Jun 29, 2016

In Brief

A Phase 4 clinical trial evaluating tDCS for Lennox-Gastaut Syndrome. Completed, enrolled 22 participants.

Detailed Summary

Background: Lennox-Gastaut syndrome (LGS) is a severe childhood epileptic syndrome with high pharmacoresistance. The treatment outcomes are still unsatisfied. The investigator previous study of cathodal transcranial direct current stimulation (tDCS) in children with focal epilepsy showed significant reduction in epileptiform discharges. The investigator hypothesized that cathodal tDCS when applied over the primary motor cortex (M1) combined with pharmacologic treatment will be more effective for reducing seizure frequency in participants with LGS than pharmacologic treatment alone. Material and Method: Study participants were randomized to receive either: 1. pharmacologic treatment with 5-consecutive days of 2 milliampere (mA) cathodal tDCS over M1 for 20 min or 2. pharmacologic treatment plus sham tDCS. Measures of seizure frequency and epileptic discharges were performed before treatment and again immediately post-treatment and 1-, 2-, 3-, and 4-week follow-up.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 7, 2016
Enrollment StartAug 1, 2010
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.2 years ago

Interventions

tDCSdevice

brain stimulation by cathodal electrode at motor cortex