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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
HD-tDCS group
Conventional tDCS group
Sham HD-tDCS group
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

HD-tDCS group

Conventional tDCS group

Sham HD-tDCS group

Arm Description

Constant current (1mA) will be applied for 20min and the anode will be placed over the defined target area

Constant current (1mA) will be applied for 20min and the anode will be placed over the standard C3/C4 position

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).
Magnetic Resonance Imaging
Functional magnetic resonance imaging

Full Information

First Posted
March 13, 2019
Last Updated
September 3, 2021
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03875677
Brief Title
High-definition Transcranial Direct Current Stimulation for Facilitating Hand Function Recovery After Stroke
Official Title
Using Neuroimage and Computational Modeling to Customize High-definition Transcranial Direct Current Stimulation Protocols for Facilitating Hand Function Recovery After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HD-tDCS group
Arm Type
Experimental
Arm Description
Constant current (1mA) will be applied for 20min and the anode will be placed over the defined target area
Arm Title
Conventional tDCS group
Arm Type
Experimental
Arm Description
Constant current (1mA) will be applied for 20min and the anode will be placed over the standard C3/C4 position
Arm Title
Sham HD-tDCS group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
HD-tDCS group
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional tDCS group
Intervention Description
A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.
Intervention Type
Device
Intervention Name(s)
Sham HD-tDCS group
Intervention Description
A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.
Primary Outcome Measure Information:
Title
Action Research Arm Test (ARAT)
Description
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).
Time Frame
3-month after the 10th session training
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment (Upper Extremity)
Description
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.
Time Frame
3-month after the 10th session training
Title
Wolf Motor Function Test (WMFT)
Description
The WMFT measures upper limb ability through timed and functional tasks. It has 17 items, ranging from 0 to 5 (worse to best).
Time Frame
3-month after the 10th session training
Title
Magnetic Resonance Imaging
Description
Functional magnetic resonance imaging
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Tong, PhD
Organizational Affiliation
Department of Biomedical Engineering, CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biomedical Engineering, The Chinese University of Hong Kong
City
Shatin
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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