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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: HD-tDCS group; Device: Conventional tDCS group; Device: Sham HD-tDCS group

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Department of Biomedical Engineering, The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HD-tDCS group; Constant current (1mA) will be applied for 20min and the anode will be placed over the defined target area	Device: HD-tDCS group; 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.
Experimental: Conventional tDCS group; Constant current (1mA) will be applied for 20min and the anode will be placed over the standard C3/C4 position	Device: Conventional tDCS group; A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.
Sham Comparator: 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.	Device: Sham HD-tDCS group; A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2019
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 3, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2017.155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No