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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03875677
• Other study ID #: 2017.155
• Status: Completed
• Phase: N/A
• Start date: April 10, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: September 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 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.
• Conventional tDCS group
A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.
• Sham HD-tDCS group
A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.

Locations

Country	Name	City	State
Hong Kong	Department of Biomedical Engineering, The Chinese University of Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	3-month after the 10th session training
Secondary	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).	3-month after the 10th session training
Secondary	Magnetic Resonance Imaging	Functional magnetic resonance imaging	Baseline