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Clinical Trials/NCT02987361
NCT02987361
Unknown
Not Applicable

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

Chonbuk National University Hospital1 site in 1 country72 target enrollmentNovember 2016
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Chonbuk National University Hospital
Enrollment
72
Locations
1
Primary Endpoint
Fugl-Meyer Upper Motor Score change
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
August 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Myoung Hwan Ko

Professor

Chonbuk National University Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Fugl-Meyer Upper Motor Score change

Time Frame: before treatment, 48 hours after treatment, 4 weeks after treatment

Secondary Outcomes

  • 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)
  • Manual Muscle Test (MMT) change(before treatment, 48 hours after treatment, 4 weeks after treatment)

Study Sites (1)

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