Clinical Trials Directory

Trials / Completed

CompletedNCT02827864

Efficacy and Time Dependent Effects of tDCS Combined With MT for Rehabilitation After Subacute and Chronic Stroke

Efficacy and Time Dependent Effects of Transcranial Direct Current Stimulation (tDCS) Combined With Mirror Therapy for Rehabilitation After Subacute and Chronic Stroke

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
1 (actual)
Sponsor
Chang Gung Memorial Hospital · Academic / Other
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

Summary

This project is designed to investigate the intervention effects and time dependent effects of combining tDCS and MT in patients with subacute and chronic stroke.

Detailed description

This project is also designed to investigate the optimal application timing of tDCS in combination with MT in patients with subacute and chronic stroke. Patients with subacute and chronic stroke will be recruited and randomized into one of the 3 groups: sequentially apply tDCS and MT group (SEQ), apply tDCS concurrently with MT group (CON), and MT with sham tDCS group (SHAM). All participants will receive 40 minutes of MT followed by 30 minutes of functional task training. For the participants in the SEQ group, 20 minutes of tDCS will be applied prior to MT, while tDCS will be applied concurrently with MT for the first 20 minutes in the CON group. As for the SHAM group, tDCS electrodes will be placed on the scalp without actual current output. The interventions will be carried out 90 minutes per day, 5 days per week, for 4 weeks. Behavioral outcomes will be assessed by blinded evaluators before, after, and 3 months post intervention. To study the possible interaction of treatment group and time of outcome evaluations, group (SEQ vs. CON vs. SHAM groups) × time (pretest vs. posttest vs. follow-up) repeated measures ANOVA will be performed. Additionally, the partial eta square (η2) will be calculated to determine the effect size of interest.

Conditions

Interventions

TypeNameDescription
BEHAVIORALsequentially apply tDCS and MTThe participants in the SEQ group will first receive a-tDCS applied over M1lesioned without any active arm practice for 20 minutes. For the following 20 minutes, the participants will receive the MT, while the electrodes will be remained on the scalp without stimulation (sham tDCS). Then the electrodes will be removed from the scalp, and the participants will continue another 20 minutes of MT without tDCS. The treatment session will be ended with 30 minutes of functional task practice.
BEHAVIORALapply tDCS concurrentlySham tDCS will be first applied for 20 minutes without active arm practice. Twenty minutes of a-tDCS will then be applied concurrently with MT followed by another 20 minutes of MT without tDCS. The participants will also practice functional tasks for 30 minutes after MT.
BEHAVIORALMT with sham tDCSThe training procedure will be the same as the above 2 groups except that sham tDCS will be provided in the first 40 minutes.

Timeline

Start date
2017-10-30
Primary completion
2018-02-28
Completion
2020-02-13
First posted
2016-07-11
Last updated
2020-06-18

Locations

2 sites across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT02827864. Inclusion in this directory is not an endorsement.