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CompletedNCT03875677Updated Sep 13, 2021

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

An interventional study of HD-tDCS group and Conventional tDCS group in Stroke, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-13.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Stroke

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 25 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

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Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DeviceHD-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.

  • DeviceConventional tDCS group

    A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.

  • DeviceSham HD-tDCS group

    A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 3-month after the 10th session training

Secondary outcomes

  1. 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.

    Time frame: 3-month after the 10th session training

  2. 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).

    Time frame: 3-month after the 10th session training

  3. Magnetic Resonance Imaging

    Functional magnetic resonance imaging

    Time frame: Baseline

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Study locations

1 site
  • Department of Biomedical Engineering, The Chinese University of Hong Kong
    Shatin, Hong Kong
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03875677
Lead sponsor
Chinese University of Hong Kong
Responsible party
Raymond KY Tong (Chairman and Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Mar 15, 2019
Start date
Apr 10, 2019
Primary completion
Jun 1, 2020
Completion
Jun 1, 2020
Last update
Sep 13, 2021

Study contacts

Raymond Tong, PhD
principal investigator · Department of Biomedical Engineering, CUHK

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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