Motor Excitability Study of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Chronic Stroke

Stroke Clinical Trial

Official title:

Motor Excitability Study of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Chronic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02960009
• Other study ID #: 2015.691-T
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2022
• Source: Chinese University of Hong Kong
• Contact: Raymond Kai-yu Tong, PhD
• Phone: +852 3943 8454
• Email: kytong[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

High definition tDCS will be conducted to both stroke and healthy subjects on primary motor cortex area to explore the motor excitability changes before and after stimulation. In next stage, a randomized control trial with 20-session training will be conducted to evaluate the effectiveness of transient modulation of cortical excitability through multisite HD-tDCS with EMG driven robot hand training, a sham stimulation with EMG-driven robot hand training will be applied as control group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment;

2. Have moderate to severe motor disability at the paretic upper limb (assessed by Fugl-Meter Assessment (FMA), and Action Research Arm Test (ARAT));

3. Hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection

Exclusion Criteria:

1. Severe hand spasticity, open hand wound or hand deformity;

2. Visual field deficits;

3. Aphasia, neglect, and apraxia;

4. History of alcohol, drug abuse or epilepsy;

5. Bilateral infracts;

6. Uncontrolled medical problems;

7. Serious cognitive deficits [Mini-Mental State Examination (MMSE) < 21];

8. Major depression

9. Metal implants inside body

10. MRI, TMS and tDCS contraindications

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• HD-tDCS
Different stimulation protocols will be applied to the primary motor cortex of stroke patients. After 20-minute stimulation, EMG-driven robot hand training will be conducted.

Locations

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

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	Electroencephalography (EEG) and Electromyography (EMG)	It is used to investigate the changes in corticomuscular coherence for studying connectivity between the brainwave using EEG and the affected hand muscles using EMG. In addition, EMG will be used to detect muscle activation change and muscle co-contraction pattern alteration.	Before intervention, During intervention, After intervention, 6-month after intervention
Primary	Action Research Arm Test (ARAT)	The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement) to assess upper limb functioning	Before intervention, After intervention, 6-month after intervention
Primary	Fugl-Meyer Assessment Upper Extremity (FMA-UE)	It is used to evaluate and measure upper-limb recovery in post-stroke hemiplegic patients, and items are scored on a 3-point ordinal scale	Before intervention, After intervention, 6-month after intervention
Secondary	Magnetic Resonance Imaging (MRI)	It is used to identify neural correlates of stimulation-induced behavioral gains for investigating tDCS-induced changes in brain activations	Before intervention, After intervention, 6-month after intervention
Secondary	Transcranial Magnetic Stimulation (TMS)	It is used to measure the changes in interhemispheric imbalance and corticospinal excitability	Before intervention