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Effects of Transcranial Drect Current Stimulation on Hemiplegic Upper Extremity Function After Stroks

Status Approved

First Submitted Date

2016/08/31
Registered Date

2017/11/17
Last Updated Date

2018/05/28

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002543
Unique Protocol ID	CUH2016-03-015
Public/Brief Title	Effect of tDCS on Upper Extremity After Stroks
Scientific Title	Effects of Transcranial Drect Current Stimulation on Hemiplegic Upper Extremity Function After Stroks
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	Yes
Name of Registry / Registration Number	ClinicalTrials.gov-NCT02987361
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	CUH 2016-03-015-008
Approval Date	2016-09-08
Institutional Review Board Name	CHONBUK NATIONAL UNIVERSITY HOSPITAL IRB
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	KO MYOUNG HWAN
Title	MD, PhD
Telephone	+82-63-250-1795
Affiliation	Jeonbuk National University Hospital
Address	20, GeonJi-ro, Deokjin-gu, Jeonju, Jeonbuk
Contact Person for Public Queries
Name	YU MIN JUNG
Title	Manager
Telephone	+82-63-259-3458
Affiliation	Jeonbuk National University Hospital
Address	20, GeonJi-ro, Deokjin-gu, Jeonju, Jeonbuk
Contact Person for Updating Information
Name	YU MIN JUNG
Title	Manager
Telephone	+82-63-259-3458
Affiliation	Jeonbuk National University Hospital
Address	20, GeonJi-ro, Deokjin-gu, Jeonju, Jeonbuk

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 3
Overall Recruitment Status	Recruiting
Date of First Enrollment	2016-10-24 Actual
Target Number of Participant	72
Primary Completion Date	2017-08-31 , Anticipated
Study Completion Date	2017-08-31 , Anticipated
Name of Study	Jeonbuk National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2016-10-24 ,
Recruitment Status by Participating Study Site 2
Name of Study	Samsung Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2016-10-24 ,
Recruitment Status by Participating Study Site 3
Name of Study	Pusan National University Yangsan Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2016-10-24 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Jeonbuk National University Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Jeonbuk National University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	We hypothesize that transcranial direct current stimulation (tDCS) can improve upper limb motor recovery in the subacute 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 subacute 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 20minute a day, 5days per weeks, totally 2weeks. Fugl-Meyer upper motor score will be measured as a primary outcome.

Study Summary Information

Lay Summary

We hypothesize that transcranial direct current stimulation (tDCS) can improve upper
limb motor recovery in the subacute 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 subacute 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 20minute a day, 5days per weeks, totally
2weeks.
Fugl-Meyer upper motor score will be measured as a primary outcome.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Supportive Care
Phase	Not applicable
Intervention Model	Factorial
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Medical Device
Intervention Description	The stimulation will be conducted 2mA for 20minute a day, 5days per weeks, totally 2weeks.
Number of Arms	4
Arm 1	Arm Label anodal stimulation on the lesioned primary motor cortex
	Target Number of Participant 18
	Arm Type Experimental
	Arm Description anodal stimulation on the lesioned primary motor cortex The stimulation will be conducted 2mA for 20minute a day, 5days per weeks, totally 2weeks.
Arm 2	Arm Label cathodal stimulation on the non-lesioned primary motor cortex
	Target Number of Participant 18
	Arm Type Experimental
	Arm Description cathodal stimulation on the non-lesioned primary motor cortex The stimulation will be conducted 2mA for 20minute a day, 5days per weeks, totally 2weeks.
Arm 3	Arm Label dual stimulation such as anodal stimulation on the lesioned side and cathodal stimulation on the non-lesioned side
	Target Number of Participant 18
	Arm Type Experimental
	Arm Description dual stimulation such as anodal stimulation on the lesioned side and cathodal stimulation on the non-lesioned side The stimulation will be conducted 2mA for 20minute a day, 5days per weeks, totally 2weeks.
Arm 4	Arm Label sham stimulation
	Target Number of Participant 18
	Arm Type Sham comparator
	Arm Description shame stimulation 20minute a day, 5days per weeks, totally 2weeks.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (I00-I99)Diseases of the circulatory system (I64)Stroke, not specified as haemorrhage or infarction
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~85Year
	Description 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
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Fugl-Meyer upper motor score
Timepoint	Pre-evaluation, Post-evaluaton 1, Post evaluation 2
Secondary Outcome(s) 1
Outcome	MMT(Manual muscle test)
Timepoint	Pre-evaluation, Post-evaluaton 1, Post evaluation 2
Secondary Outcome(s) 2
Outcome	KMBI(Korea modified bathel index)
Timepoint	Pre-evaluation, Post-evaluaton 1, Post evaluation 2
Secondary Outcome(s) 3
Outcome	ROM (Range of motion)
Timepoint	Pre-evaluation, Post-evaluaton 1, Post evaluation 2

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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