Effect of tDCS on Upper Extremity After Strokes

December 7, 2016 updated by: Myoung Hwan Ko, Chonbuk National University Hospital

Effects of Transcranial Direct Current Stimulation on Hemiplegic Upper Extremity Function After Strokes

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group 1
anodal stimulation on the lesioned primary motor cortex DC-STIMULATOR PLUS
Device: DC-STIMULATOR PLUS
2mA for 20minutes a day, 5 days per weeks, totally 2 weeks
Other Names:
  • tDCS
Experimental: treatment group 2
cathodal stimulation on the non-lesioned primary motor cortex DC-STIMULATOR PLUS
Device: DC-STIMULATOR PLUS
2mA for 20minutes a day, 5 days per weeks, totally 2 weeks
Other Names:
  • tDCS
Experimental: treatment group 3
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
2mA for 20minutes a day, 5 days per weeks, totally 2 weeks
Other Names:
  • tDCS
Sham Comparator: sham group
Device: DC-STIMULATOR PLUS
2mA for 20minutes a day, 5 days per weeks, totally 2 weeks
Other Names:
  • tDCS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Manual Muscle Test (MMT) change
Time Frame: before treatment, 48 hours after treatment, 4 weeks after treatment
before treatment, 48 hours after treatment, 4 weeks after treatment
Range of Motion (ROM) change
Time Frame: before treatment, 48 hours after treatment, 4 weeks after treatment
before treatment, 48 hours after treatment, 4 weeks after treatment
Korean version Modified Bathel Index (KMBI) change
Time Frame: before treatment, 48 hours after treatment, 4 weeks after treatment
before treatment, 48 hours after treatment, 4 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonbuk National University Hospital

Collaborators

Samsung Medical Center
Pusan National University Yangsan Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

December 7, 2016

First Posted (Estimate)

December 8, 2016

Study Record Updates

Last Update Posted (Estimate)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBNUH_MDCTC_2015_tDCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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