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

NCT ID: NCT03875677

Last Updated: 2021-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-10

Study Completion Date

2020-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HD-tDCS group

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

Group Type EXPERIMENTAL

HD-tDCS group

Intervention Type 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

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

Group Type EXPERIMENTAL

Conventional tDCS group

Intervention Type 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

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.

Group Type SHAM_COMPARATOR

Sham HD-tDCS group

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Conventional tDCS group

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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Raymond KY Tong

Chairman and Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Raymond Tong, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Biomedical Engineering, CUHK

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Biomedical Engineering, The Chinese University of Hong Kong

Shatin, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017.155

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.