High-definition Transcranial Direct Current Stimulation for Facilitating Hand Function Recovery After Stroke

Study Overview
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Brief Summary
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Transcranial direct current stimulation (tDCS) had recently been shown having feasibility in modulating cortical excitability transiently during motor training in a noninvasive way. The findings support that tDCS and motor practice can positively promote post-stroke motor learning to improve upper-limb motor recovery after stroke. A randomized controlled trial will be conducted with three groups: HD-tDCS, conventional tDCS and sham HD-tDCS. A 10-session training will be provided to evaluate the effectiveness of transient modulation of cortical excitability through tDCS with clinical assessment scores.

Official Title
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Using Neuroimage and Computational Modeling to Customize High-definition Transcranial Direct Current Stimulation Protocols for Facilitating Hand Function Recovery After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: HD-tDCS group
* Device: Conventional tDCS group
* Device: Sham HD-tDCS group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemiparesis subsequent to first-ever unilateral stroke for more than 6 months; MCP and PIP finger joints can be extended to 180° passively; Sufficient cognition to follow the experimental instructions Exclusion Criteria: Severe hand spasticity or hand deformity; History of alcohol or drug abuse or epilepsy; Bilateral brain infarcts; Severe cognitive deficits; Comprehensive aphasia; Contraindications to tDCS

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HD-tDCS group<br>Constant current (1mA) will be applied for 20min and the anode will be placed over the defined target area | Device: HD-tDCS group<br>* 5 sintered Ag/AgCl ring electrodes will be used at a radius of  5cm. The electrodes will be placed inside plastic electrode holders which will be filled with gel to have better contact with the scalp.<br>|
| Experimental: Conventional tDCS group<br>Constant current (1mA) will be applied for 20min and the anode will be placed over the standard C3/C4 position | Device: Conventional tDCS group<br>* A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.<br>|
| Sham Comparator: Sham HD-tDCS group<br>The stimulator will be shut down after 30s of stimulation. The patients will feel the initial itching sensation at the beginning in order to evaluate the placebo effect. | Device: Sham HD-tDCS group<br>* A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Arm Test (ARAT) | The ARAT has total 19 items, divided into 4 categories (grasp, grip, pinch, and gross arm movement). It ranges from 3 to 0 (best to worse). | 3-month after the 10th session training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment (Upper Extremity) | The maximum score is 66, divided into 33 items in the form of a 3-point scale (0-2), 0 is cannot perform and 2 performs fully. | 3-month after the 10th session training | 
| Wolf Motor Function Test (WMFT) | The WMFT measures upper limb ability through timed and functional tasks. It has 17 items, ranging from 0 to 5 (worse to best). | 3-month after the 10th session training | 
| Magnetic Resonance Imaging | Functional magnetic resonance imaging | Baseline |