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

Not yet recruiting

Phase N/A Results N/A

Trial Description

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

  • Sequentially apply tDCS and MT Behavioral
    Other Names: SEQ
    Intervention Desc: The 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.
    ARM 1: Kind: Experimental
    Label: sequentially apply tDCS and MT
  • Apply tDCS concurrently Behavioral
    Other Names: CON
    Intervention Desc: Sham 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.
    ARM 1: Kind: Experimental
    Label: apply tDCS concurrently
  • MT with sham tDCS Behavioral
    Other Names: SHAM
    Intervention Desc: The training procedure will be the same as the above 2 groups except that sham tDCS will be provided in the first 40 minutes.
    ARM 1: Kind: Experimental
    Label: MT with sham tDCS

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change scores of Fugl-Meyer Assessment (FMA) baseline, 1 month, 4 months No
Primary Change scores of Revised Nottingham Sensory Assessment (rNSA) baseline, 1 month No
Primary Change scores of Medical Research Council scale (MRC) baseline, 1 month No
Primary Change scores of MyotonPro baseline, 1 month No
Primary Change scores of Wolf Motor Function Test (WMFT) baseline, 1 month No
Primary Change scores of Motor Activity Log (MAL) baseline, 1 month, 4 months No
Primary Change scores of Actigraphy baseline, 1 month No
Primary Change scores of ABILHAND Questionnaire baseline, 1 month, 4 months No
Primary Change scores of Modified Ashworth Scale (MAS) baseline, 1 month No
Primary Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL) baseline, 1 month, 4 months No
Primary Stroke Impact Scale Version 3.0 (SIS 3.0) baseline, 1 month, 4 months No
Primary Change scores of Functional Independence Measure (FIM) baseline, 1 month No
Secondary Change scores of Adelaide Activities Profile (AAP) baseline, 1 month No
Secondary Change scores of 10-Meter Walk Test (10MWT) baseline, 1 month No
Secondary Change scores of Stroop test baseline, 1 month No
Secondary Change scores of pressure pain threshold baseline, 1 month No
Secondary Change scores of Dual-Task Block and Box Test baseline, 1 month, 4 months No
Secondary Change scores of EuroQol (EQ)-5D questionnaire baseline, 1 month No
Secondary Change scores of Pinch and grasp dynamometer baseline, 1 month No
Secondary Change scores of The Chedoke Arm and Hand Activity Inventory (CAHAI) baseline, 1 month No
Secondary Change scores of The Facial Pain Scale-Revised (FPS-R ) baseline, 1 month No
Secondary Change scores of Modified Rankin Scale (mRS) baseline, 1 month No
Secondary Change scores of The short form of the Betts Questionnaire Upon Mental Imagery (Betts QMI) baseline, 1 month No
Secondary Change scores of The Facial Fatigue Scale-Revised (FFS-R) baseline, 1 month No

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