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Completed

NCT Number: NCT03875677

High-definition Transcranial Direct Current Stimulation 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biomedical Engineering, The Chinese University of Hong Kong

Shatin, Hong Kong

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HD-tDCS group

Device

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.

Conventional tDCS group

Device

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

Sham HD-tDCS group

Device

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

Primary outcomes

  1. Action Research Arm Test (ARAT)

    Time frame: 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 outcomes

  1. Fugl-Meyer Assessment (Upper Extremity)

    Time frame: 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.

  2. Wolf Motor Function Test (WMFT)

    Time frame: 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).

  3. Magnetic Resonance Imaging

    Time frame: Baseline

    Functional magnetic resonance imaging

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 15, 2019
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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