Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
72 participants
INTERVENTIONAL
2016-11-30
2018-08-31
Brief Summary
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This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
DOUBLE
Study Groups
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treatment group 1
anodal stimulation on the lesioned primary motor cortex DC-STIMULATOR PLUS
DC-STIMULATOR PLUS
2mA for 20minutes a day, 5 days per weeks, totally 2 weeks
treatment group 2
cathodal stimulation on the non-lesioned primary motor cortex DC-STIMULATOR PLUS
DC-STIMULATOR PLUS
2mA for 20minutes a day, 5 days per weeks, totally 2 weeks
treatment group 3
dual stimulation such as anodal stimulation on the lesioned side and cathodal stimulation on the non-lesioned side DC-STIMULATOR PLUS
DC-STIMULATOR PLUS
2mA for 20minutes a day, 5 days per weeks, totally 2 weeks
sham group
sham group
DC-STIMULATOR PLUS
2mA for 20minutes a day, 5 days per weeks, totally 2 weeks
Interventions
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DC-STIMULATOR PLUS
2mA for 20minutes a day, 5 days per weeks, totally 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Convulsive disorders
3. History of brain diseases other than stroke
20 Years
85 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Pusan National University Yangsan Hospital
OTHER
Chonbuk National University Hospital
OTHER
Responsible Party
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Myoung Hwan Ko
Professor
Principal Investigators
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Myoung Hwan Ko, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
634-18, Geumam-dong, Deokjin-gu, Jeonju, Jeonbuk, 561-712 Republic of Korea
Locations
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Kim Yeon Hee
Seoul, Ilwon, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CBNUH_MDCTC_2015_tDCS
Identifier Type: -
Identifier Source: org_study_id
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