CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 82 enrolled
Drug / intervention
Transcranial direct current stimulation +1 moredevice
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/NCT03562663
NCT03562663N/ACompleted

Transcranial Direct Current Stimulation and Robotic Training in Chronic Stroke

Burke Medical Research Institute·interventional·Posted Jun 19, 2018·Updated Jan 20, 2021

In Brief

A clinical study evaluating Transcranial direct current stimulation and Upper extremity robotics for Chronic Stroke. Completed, enrolled 82 participants.

Detailed Summary

Motor skill training and transcranial direct current stimulation (tDCS) have separately been shown to alter cortical excitability and enhance motor function in humans. Their combination is appealing for augmenting motor recovery in stroke patients, and this is an area presently under heavy investigation globally. The investigators have previously shown that the timing of tDCS application has functional significance, that tDCS applied prior to training can be beneficial for voluntary behavior, and that tDCS effects may not simply be additive to training effects, but may change the nature of the training effect. The investigators have separately reported in a randomized-controlled clinical trial, that upper limb robotic training alone over 12 weeks can improve clinical function of chronic stroke patients. Based on our results with tDCS and robotic training, the investigators hypothesize that the same repeated sessions of robotic training, but preceded by tDCS, would lead to a sustained and functional change greater than robotic training alone. The investigators will determine if clinical function can be improved and sustained with tDCS-robotic training and cortical physiology changes that underlie functional improvements.

Study Details

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 19, 2018
Enrollment StartJan 1, 2012
Primary CompletionJan 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 8.0 years ago

Interventions

Transcranial direct current stimulationdevice

A constant, low current stimulation is provided non-invasively through sponge electrodes positioned over the motor cortex of the affected arm. The stimulation is provided for 20 minutes at an intensity of 2 mA.

Upper extremity roboticsdevice

Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study.