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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02960009
Enrollment
30
Registered
2016-11-09
Start date
2016-06-20
Completion date
2022-12-31
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Brief 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.

Interventions

DEVICEHD-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.

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Electroencephalography (EEG) and Electromyography (EMG)Before intervention, During intervention, After intervention, 6-month after interventionIt 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.
Action Research Arm Test (ARAT)Before intervention, After intervention, 6-month after interventionThe ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement) to assess upper limb functioning
Fugl-Meyer Assessment Upper Extremity (FMA-UE)Before intervention, After intervention, 6-month after interventionIt is used to evaluate and measure upper-limb recovery in post-stroke hemiplegic patients, and items are scored on a 3-point ordinal scale

Secondary

MeasureTime frameDescription
Magnetic Resonance Imaging (MRI)Before intervention, After intervention, 6-month after interventionIt is used to identify neural correlates of stimulation-induced behavioral gains for investigating tDCS-induced changes in brain activations
Transcranial Magnetic Stimulation (TMS)Before interventionIt is used to measure the changes in interhemispheric imbalance and corticospinal excitability

Countries

Hong Kong

Contacts

Primary ContactRaymond Kai-yu Tong, PhD
kytong@cuhk.edu.hk+852 3943 8454

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026