Effect of tDCS on Upper Extremity After Strokes

Chonbuk National University

Status: Unknown

Conditions: Stroke

Treatments: Device: DC-STIMULATOR PLUS

Study type: Interventional

Funder types: Other

Identifiers

NCT02987361

CBNUH_MDCTC_2015_tDCS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

72 participants in 4 patient groups

treatment group 1

Experimental group

Description:

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

Treatment:

Device: DC-STIMULATOR PLUS

treatment group 2

Experimental group

Description:

cathodal stimulation on the non-lesioned primary motor cortex DC-STIMULATOR PLUS

Treatment:

Device: DC-STIMULATOR PLUS

treatment group 3

Experimental group

Description:

dual stimulation such as anodal stimulation on the lesioned side and cathodal stimulation on the non-lesioned side DC-STIMULATOR PLUS

Treatment:

Device: DC-STIMULATOR PLUS

sham group

Sham Comparator group

Description:

sham group

Treatment:

Device: DC-STIMULATOR PLUS