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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: HD-tDCS group; Device: Conventional tDCS group; Device: Sham HD-tDCS group

• Registration Number: NCT03875677
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Study Start: 2019-04-10
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-03
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Hemiparesis subsequent to first-ever unilateral stroke for more than 6 months;
2. MCP and PIP finger joints can be extended to 180° passively;
3. Sufficient cognition to follow the experimental instructions

Exclusion Criteria

1. Severe hand spasticity or hand deformity;
2. History of alcohol or drug abuse or epilepsy;
3. Bilateral brain infarcts;
4. Severe cognitive deficits;
5. Comprehensive aphasia;
6. Contraindications to tDCS

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HD-tDCS group	HD-tDCS group	Constant current (1mA) will be applied for 20min and the anode will be placed over the defined target area
Conventional tDCS group	Conventional tDCS group	Constant current (1mA) will be applied for 20min and the anode will be placed over the standard C3/C4 position
Sham HD-tDCS group	Sham HD-tDCS group	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.

Primary Outcome Measures

Name	Time	Method
Action Research Arm Test (ARAT)	3-month after the 10th session training	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).

Secondary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment (Upper Extremity)	3-month after the 10th session training	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.
Magnetic Resonance Imaging	Baseline	Functional magnetic resonance imaging
Wolf Motor Function Test (WMFT)	3-month after the 10th session training	The WMFT measures upper limb ability through timed and functional tasks. It has 17 items, ranging from 0 to 5 (worse to best).

Trial Locations

Locations (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong; 🇭🇰 Shatin, Hong Kong