Effect of tDCS on Upper Extremity After Strokes

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02987361
• Other study ID #: CBNUH_MDCTC_2015_tDCS
• Status: Recruiting
• Phase: N/A
• First received: August 31, 2016
• Last updated: December 7, 2016
• Start date: November 2016
• Est. completion date: August 2018

Study information

• Verified date: December 2016
• Source: Chonbuk National University Hospital
• Contact: Min Jung YU, MANAGER
• Phone: 82-63-259-3458
• Email: mjyu[@]mdctc.or.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: August 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• DC-STIMULATOR PLUS
2mA for 20minutes a day, 5 days per weeks, totally 2 weeks

Locations

Country	Name	City	State
Korea, Republic of	Kim Yeon Hee	Seoul City	Ilwon

Sponsors (3)

Lead Sponsor	Collaborator
Chonbuk National University Hospital	Pusan National University Yangsan Hospital, Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Upper Motor Score change		before treatment, 48 hours after treatment, 4 weeks after treatment	No
Secondary	Manual Muscle Test (MMT) change		before treatment, 48 hours after treatment, 4 weeks after treatment	No
Secondary	Range of Motion (ROM) change		before treatment, 48 hours after treatment, 4 weeks after treatment	No
Secondary	Korean version Modified Bathel Index (KMBI) change		before treatment, 48 hours after treatment, 4 weeks after treatment	No