NCT03875677

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

April 10, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

March 13, 2019

Last Update Submit

September 3, 2021

Conditions

Stroke

Outcome Measures

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).

    3-month after the 10th session training

Secondary Outcomes (3)

  • Fugl-Meyer Assessment (Upper Extremity)

    3-month after the 10th session training

  • Wolf Motor Function Test (WMFT)

    3-month after the 10th session training

  • Magnetic Resonance Imaging

    Baseline

Study Arms (3)

HD-tDCS group

EXPERIMENTAL

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

Device: HD-tDCS group

Conventional tDCS group

EXPERIMENTAL

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 HD-tDCS group

SHAM COMPARATOR

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

HD-tDCS groupDEVICE

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.

HD-tDCS group
Conventional tDCS groupDEVICE

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

Conventional tDCS group
Sham HD-tDCS groupDEVICE

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

Sham HD-tDCS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Raymond Tong, PhD

    Department of Biomedical Engineering, CUHK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman and Professor

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 15, 2019

Study Start

April 10, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

September 13, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)