Motor Excitability Study of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Chronic Stroke
- Conditions
- Stroke
- Interventions
- Device: HD-tDCS
- Registration Number
- NCT02960009
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment;
- Have moderate to severe motor disability at the paretic upper limb (assessed by Fugl-Meter Assessment (FMA), and Action Research Arm Test (ARAT));
- Hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection
- Severe hand spasticity, open hand wound or hand deformity;
- Visual field deficits;
- Aphasia, neglect, and apraxia;
- History of alcohol, drug abuse or epilepsy;
- Bilateral infracts;
- Uncontrolled medical problems;
- Serious cognitive deficits [Mini-Mental State Examination (MMSE) < 21];
- Major depression
- Metal implants inside body
- MRI, TMS and tDCS contraindications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Sham HD-tDCS HD-tDCS 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. Cathode HD-tDCS HD-tDCS 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. Anode HD-tDCS HD-tDCS 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.
- Primary Outcome Measures
Name Time Method Action Research Arm Test (ARAT) Before intervention, After intervention, 6-month after intervention The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement) to assess upper limb functioning
Electroencephalography (EEG) and Electromyography (EMG) Before intervention, During intervention, After intervention, 6-month after intervention It is used to investigate the changes in corticomuscular coherence for studying connectivity between the brainwave using EEG and the affected hand muscles using EMG. In addition, EMG will be used to detect muscle activation change and muscle co-contraction pattern alteration.
Fugl-Meyer Assessment Upper Extremity (FMA-UE) Before intervention, After intervention, 6-month after intervention It is used to evaluate and measure upper-limb recovery in post-stroke hemiplegic patients, and items are scored on a 3-point ordinal scale
- Secondary Outcome Measures
Name Time Method Magnetic Resonance Imaging (MRI) Before intervention, After intervention, 6-month after intervention It is used to identify neural correlates of stimulation-induced behavioral gains for investigating tDCS-induced changes in brain activations
Transcranial Magnetic Stimulation (TMS) Before intervention It is used to measure the changes in interhemispheric imbalance and corticospinal excitability
Trial Locations
- Locations (1)
Department of Biomedical Engineering, The Chinese University of Hong Kong
ðŸ‡ðŸ‡°Hong Kong, Hong Kong