Motor Excitability Study of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Chronic Stroke

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Stroke

Treatments: Device: HD-tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT02960009

2015.691-T

Details and patient eligibility

About

High definition tDCS will be conducted to both stroke and healthy subjects on primary motor cortex area to explore the motor excitability changes before and after stimulation. In next stage, a randomized control trial with 20-session training will be conducted to evaluate the effectiveness of transient modulation of cortical excitability through multisite HD-tDCS with EMG driven robot hand training, a sham stimulation with EMG-driven robot hand training will be applied as control group.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment;
2. Have moderate to severe motor disability at the paretic upper limb (assessed by Fugl-Meter Assessment (FMA), and Action Research Arm Test (ARAT));
3. Hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection

Exclusion criteria

1. Severe hand spasticity, open hand wound or hand deformity;
2. Visual field deficits;
3. Aphasia, neglect, and apraxia;
4. History of alcohol, drug abuse or epilepsy;
5. Bilateral infracts;
6. Uncontrolled medical problems;
7. Serious cognitive deficits [Mini-Mental State Examination (MMSE) < 21];
8. Major depression
9. Metal implants inside body
10. MRI, TMS and tDCS contraindications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

Anode HD-tDCS

Experimental group

Description:

The center anode is fixed on the ipsilesional primary motor cortex and the 4 surrounding cathode electrodes will be placed about 6 cm to the center.

Treatment:

Device: HD-tDCS

Cathode HD-tDCS

Experimental group

Description:

The center cathode is fixed on the contralesional primary motor cortex and the 4 surrounding anode electrodes will be placed about 6 cm to the center.

Treatment:

Device: HD-tDCS

Sham HD-tDCS

Placebo Comparator group

Description:

The center anode is fixed on the ipsilesional primary motor cortex and the 4 surrounding cathode electrodes will be placed about 6 cm to the center.

Treatment:

Device: HD-tDCS