Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Stroke Acute
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Factorial AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

Stroke or cerebrovascular accident is a leading cause of disabilities. Physical therapy is a standard treatment to help motor recovery after stroke. However, disabilities remained in some stroke patients despite intensive training. After stroke, there are changes of cortical excitability and brain a...

Stroke or cerebrovascular accident is a leading cause of disabilities. Physical therapy is a standard treatment to help motor recovery after stroke. However, disabilities remained in some stroke patients despite intensive training. After stroke, there are changes of cortical excitability and brain activity in both hemispheres. Lesioned hemisphere decreases cortical excitability and increases number of low-frequency brain activity, while non-lesioned hemisphere increases cortical excitability and increases number of high-frequency brain activity. Transcranial direct current stimulation (tDCS) is a technique which delivers weak direct current through scalp and can be used as an adjunctive treatment. Anodal tDCS can increase cortical excitability and amount of high-frequency brain activity while cathodal tDCS can decrease cortical excitability and increase amount of high-frequency brain activity. Increase amount of high-frequency brain activity in the lesioned hemisphere can indicate better recovery of stroke. Meta-analysis has reported benefits of both anodal and cathodal tDCS for motor recovery in stroke patients. However, only few studies have investigated tDCS effects in acute phase of stroke which is a crucial time for enhancing motor recovery. This study aims to investigate the effects of anodal- and cathodal tDCS combined with conventional physical therapy for 5 consecutive sessions on motor functions and brain activity in acute stroke patients at immediate and 1-month follow-up. Participants will be randomly assigned into 3 groups (sham-, anodal- and cathodal tDCS). Participants in the anodal and cathodal groups will receive 1.5 mA tDCS for 20 minutes before physical therapy programs for 5 consecutive sessions, while sham group will receive sham tDCS with physical therapy. Brain activity by electroencephalography and motor performances by Fugl-Meyer Assessment and Wolf Motor Function Test will be evaluated at baseline, post-intervention (day 5) and follow-up at 1 month. We hypothesize that anodal- and cathodal tDCS combined with physical therapy for 5 consecutive days can immediately increase number of high-frequency brain activity and improve motor functions and this effect will last for a month compared to sham group.

Tracking Information

NCT #
NCT04578080
Collaborators
Not Provided
Investigators
Study Director: Wanalee Klomjai, PhD MU