Effect of tDCS on Upper Extremity After Strokes

Recruiting

Phase N/A Results N/A

Trial Description

The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve upper limb motor recovery in the sub-acute phase of stroke patients.
This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.

Detailed Description

The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve upper limb motor recovery in the sub-acute phase of stroke patients.
This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.
Informed consent was obtained from all participants and procedures were conducted according to the Declaration of Helsinki. The protocol was approved by the Chonbuk National Uni. Hospital IRB, KOREA.
Seventy-two stroke patients in the sub-acute phase will be recruited in three centers of neurorehabilitation in republic of Korea.
Patients will be randomly divided to four groups; group1 is anodal stimulation on the lesioned primary motor cortex, group 2 is cathodal stimulation on the non-lesioned primary motor cortex, group 3 is dual stimulation such as anodal stimulation on the lesioned side and cathod stimulation on the non-lesioned side, and group 4 is shame stimulation group.
The stimulation will be conducted 2mA for 20 minute a day, 5 days per weeks, totally 2 weeks.
Fugl-Meyer upper motor score will be measured as a primary outcome.

Conditions

Interventions

  • DC-STIMULATOR PLUS Device
    Other Names: tDCS
    Intervention Desc: 2mA for 20minutes a day, 5 days per weeks, totally 2 weeks
    ARM 1: Kind: Experimental
    Label: treatment group 1
    Description: anodal stimulation on the lesioned primary motor cortex DC-STIMULATOR PLUS
    ARM 2: Kind: Experimental
    Label: treatment group 2
    Description: cathodal stimulation on the non-lesioned primary motor cortex DC-STIMULATOR PLUS
    ARM 3: Kind: Experimental
    Label: treatment group 3
    Description: dual stimulation such as anodal stimulation on the lesioned side and cathodal stimulation on the non-lesioned side DC-STIMULATOR PLUS
    ARM 4: Kind: Experimental
    Label: sham group
    Description: sham group

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Upper Motor Score change before treatment, 48 hours after treatment, 4 weeks after treatment
Secondary Manual Muscle Test (MMT) change before treatment, 48 hours after treatment, 4 weeks after treatment
Secondary Range of Motion (ROM) change before treatment, 48 hours after treatment, 4 weeks after treatment
Secondary Korean version Modified Bathel Index (KMBI) change before treatment, 48 hours after treatment, 4 weeks after treatment

Sponsors