Effect of tDCS on Upper Extremity After Strokes

Not Applicable

• Conditions: Stroke
• Interventions: Device: DC-STIMULATOR PLUS

• Registration Number: NCT02987361
• Lead Sponsor: Chonbuk National University Hospital

Brief Summary

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.

Study Timeline

• Study First Submitted: 2016-08-31
• Study Start: 2016-11
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study First Submitted QC: 2016-12-07
• Last Update Submitted: 2016-12-07
• Study First Posted: 2016-12-08
• Last Update Posted: 2016-12-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Age 20-85
2. Unilateral Stroke patients
3. Inclusion must be in the sub-acute phase defined as within 48hr-4 weeks after stroke
4. Patients who have evoked motor potentials on the first dorsal interossei muscles on hemiplegic hand
5. The patient has subscribed the informed consent

Exclusion Criteria

1. Insert a metal object on the head
2. Convulsive disorders
3. History of brain diseases other than stroke

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
treatment group 1	DC-STIMULATOR PLUS	anodal stimulation on the lesioned primary motor cortex DC-STIMULATOR PLUS
treatment group 2	DC-STIMULATOR PLUS	cathodal stimulation on the non-lesioned primary motor cortex DC-STIMULATOR PLUS
sham group	DC-STIMULATOR PLUS	sham group
treatment group 3	DC-STIMULATOR PLUS	dual stimulation such as anodal stimulation on the lesioned side and cathodal stimulation on the non-lesioned side DC-STIMULATOR PLUS

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Upper Motor Score change	before treatment, 48 hours after treatment, 4 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
Range of Motion (ROM) change	before treatment, 48 hours after treatment, 4 weeks after treatment
Korean version Modified Bathel Index (KMBI) change	before treatment, 48 hours after treatment, 4 weeks after treatment
Manual Muscle Test (MMT) change	before treatment, 48 hours after treatment, 4 weeks after treatment

Trial Locations

Locations (1)

Kim Yeon Hee; 🇰🇷 Seoul City, Ilwon, Korea, Republic of