Clinical trial NCT02987361: Effect of tDCS on Upper Extremity After Strokes
Official title: Effects of Transcranial Direct Current Stimulation on Hemiplegic Upper Extremity Function After Strokes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Pusan National University Yangsan Hospital
First posted: 2016-12-08
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer Upper Motor Score change
timeFrame: before treatment, 48 hours after treatment, 4 weeks after treatment
Secondary outcomes:
measure: Manual Muscle Test (MMT) change
timeFrame: before treatment, 48 hours after treatment, 4 weeks after treatment
measure: Range of Motion (ROM) change
timeFrame: before treatment, 48 hours after treatment, 4 weeks after treatment
measure: Korean version Modified Bathel Index (KMBI) change
timeFrame: before treatment, 48 hours after treatment, 4 weeks after treatment
Other outcomes:
Locations:
city: Seoul City
country: Korea, Republic of
facility: Kim Yeon Hee
state: Ilwon
Study officials:
affiliation: 634-18, Geumam-dong, Deokjin-gu, Jeonju, Jeonbuk, 561-712 Republic of Korea
name: Myoung Hwan Ko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: