Effect of tDCS on Upper Extremity After Strokes
Effects of Transcranial Direct Current Stimulation on Hemiplegic Upper Extremity Function After Strokes
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Nov 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
December 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedDecember 8, 2016
December 1, 2016
1 month
August 31, 2016
December 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Fugl-Meyer Upper Motor Score change
before treatment, 48 hours after treatment, 4 weeks after treatment
Secondary Outcomes (3)
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
Study Arms (4)
treatment group 1
EXPERIMENTALanodal stimulation on the lesioned primary motor cortex DC-STIMULATOR PLUS
treatment group 2
EXPERIMENTALcathodal stimulation on the non-lesioned primary motor cortex DC-STIMULATOR PLUS
treatment group 3
EXPERIMENTALdual stimulation such as anodal stimulation on the lesioned side and cathodal stimulation on the non-lesioned side DC-STIMULATOR PLUS
sham group
SHAM COMPARATORsham group
Interventions
2mA for 20minutes a day, 5 days per weeks, totally 2 weeks
Eligibility Criteria
You may qualify if:
- Age 20-85
- Unilateral Stroke patients
- Patients who have evoked motor potentials on the first dorsal interossei muscles on hemiplegic hand
- The patient has subscribed the informed consent
You may not qualify if:
- Insert a metal object on the head
- Convulsive disorders
- History of brain diseases other than stroke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chonbuk National University Hospitallead
- Samsung Medical Centercollaborator
- Pusan National University Yangsan Hospitalcollaborator
Study Sites (1)
Kim Yeon Hee
Seoul, Ilwon, 06355, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Myoung Hwan Ko, MD, PhD
634-18, Geumam-dong, Deokjin-gu, Jeonju, Jeonbuk, 561-712 Republic of Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 31, 2016
First Posted
December 8, 2016
Study Start
November 1, 2016
Primary Completion
December 1, 2016
Study Completion
August 1, 2018
Last Updated
December 8, 2016
Record last verified: 2016-12