Effect of tDCS on Upper Extremity After Strokes

NCT ID: NCT02987361

Last Updated: 2016-12-08

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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treatment group 1

anodal stimulation on the lesioned primary motor cortex DC-STIMULATOR PLUS

Group Type EXPERIMENTAL

DC-STIMULATOR PLUS

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

DC-STIMULATOR PLUS

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

DC-STIMULATOR PLUS

Intervention Type DEVICE

2mA for 20minutes a day, 5 days per weeks, totally 2 weeks

sham group

sham group

Group Type SHAM_COMPARATOR

DC-STIMULATOR PLUS

Intervention Type DEVICE

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

Intervention Type DEVICE

Other Intervention Names

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tDCS

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role collaborator

Pusan National University Yangsan Hospital

OTHER

Sponsor Role collaborator

Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Myoung Hwan Ko

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Min Jung YU, MANAGER

Role: CONTACT

82-63-259-3458 ext. 3458

Myoung Hwan Ko, MD, PhD

Role: CONTACT

82-63-250-1795 ext. 1795

Facility Contacts

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AH HE LEE, MS

Role: primary

82-2-6007-5408

Other Identifiers

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CBNUH_MDCTC_2015_tDCS

Identifier Type: -

Identifier Source: org_study_id

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