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

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT03875677

Collaborator

(none)

Enrollment

Location

Arms

13.7

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: HD-tDCS group Device: Conventional tDCS group Device: Sham HD-tDCS group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 10, 2019

Actual Primary Completion Date :

Jun 1, 2020

Actual Study Completion Date :

Jun 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.
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).
Magnetic Resonance Imaging [Baseline]
Functional magnetic resonance imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Biomedical Engineering, The Chinese University of Hong Kong	Shatin		Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator: Raymond Tong, PhD, Department of Biomedical Engineering, CUHK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Raymond KY Tong, Chairman and Professor, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT03875677

Other Study ID Numbers:

2017.155

First Posted:

Mar 15, 2019

Last Update Posted:

Sep 13, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Sep 13, 2021