Effect of tDCS on Upper Extremity After Strokes | NCT02987361

Studies
Effect of tDCS on Upper Extremity After Strokes

NCT02987361

Sponsor

Chonbuk National University Hospital

Status

Unknown status

Last Update Posted

Dec 8, 2016Estimated

Enrollment

72Estimated

Phase

Not Applicable

Conditions

Stroke

Interventions

DC-STIMULATOR PLUS

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Dec 2016Actual

Completion Date

Aug 2018Estimated

First Submitted Date

Aug 31, 2016

First Submission Date that Met QC Criteria

Dec 7, 2016

First Posted Date

Dec 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2016

Last Update Posted Date

Dec 8, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Myoung Hwan Ko, Professor, Chonbuk National University HospitalPrincipal Investigator

Lead Sponsor

Chonbuk National University HospitalOTHER

Collaborators

Name	Class
Samsung Medical Center	OTHER
Pusan National University Yangsan Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment group 1	Experimental	anodal stimulation on the lesioned primary motor cortex DC-STIMULATOR PLUS	Device: DC-STIMULATOR PLUS
treatment group 2	Experimental	cathodal stimulation on the non-lesioned primary motor cortex DC-STIMULATOR PLUS	Device: DC-STIMULATOR PLUS
treatment group 3	Experimental	dual stimulation such as anodal stimulation on the lesioned side and cathodal stimulation on the non-lesioned side DC-STIMULATOR PLUS	Device: DC-STIMULATOR PLUS
sham group	Sham Comparator	sham group	Device: DC-STIMULATOR PLUS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DC-STIMULATOR PLUS	Device	2mA for 20minutes a day, 5 days per weeks, totally 2 weeks	sham group treatment group 1 treatment group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fugl-Meyer Upper Motor Score change		before treatment, 48 hours after treatment, 4 weeks after treatment

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Min Jung YU, MANAGER	Contact	82-63-259-3458	3458	mjyu@mdctc.or.kr
Myoung Hwan Ko, MD, PhD	Contact	82-63-250-1795	1795	mhko@jbnu.ac.kr

Overall Officials

Name	Affiliation	Role
Myoung Hwan Ko, MD, PhD	634-18, Geumam-dong, Deokjin-gu, Jeonju, Jeonbuk, 561-712 Republic of Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kim Yeon Hee	Recruiting	Seoul	Ilwon	06355	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D065908	Transcranial Direct Current Stimulation

Ancestor Terms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D003295	Convulsive Therapy
D013000	Psychiatric Somatic Therapies

Browse Leaves

Not provided

Browse Branches

Not provided