Stroke
Conditions
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.
Interventions
DEVICEDC-STIMULATOR PLUS
2mA for 20minutes a day, 5 days per weeks, totally 2 weeks
Sponsors
Samsung Medical Center
Pusan National University Yangsan Hospital
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Upper Motor Score change | before treatment, 48 hours after treatment, 4 weeks after treatment |
Secondary
| Measure | Time frame |
|---|---|
| Manual Muscle Test (MMT) change | before treatment, 48 hours after treatment, 4 weeks after treatment |
| 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 |
Countries
South Korea
Contacts
Primary ContactMin Jung YU, MANAGER
Backup ContactMyoung Hwan Ko, MD, PhD
Outcome results
None listed