Multisite Transcranial Direct Current Stimulation to Promote Hand Function Recovery After Stroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Device: multisite HD-tDCS EMG-driven robot hand; Device: Sham HD-tDCS EMG-driven robot hand

• Registration Number: NCT05638464
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

A novel multisite high definition tDCS (HD-tDCS) in healthy people showed that such network-targeted stimulation could enhance motor excitability beyond traditional stimulation which targeting only one region. It showed that the excitability following multisite HD-tDCS was more than double the increase following conventional tDCS. To consider the various lesion site of different stroke survivors. The electrode placements based on personalized lesion profiles and anatomical features can be determined using finite element modeling, with lesion profiles generated from fMRI and advanced algorithms calculating the current density to maximize the modulation effect. Combining motor network interaction and the new multisite electrode montage may further provide a potential to facilitate stroke recovery.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-13
• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-27
• Study First Posted: 2022-12-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-29
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• first-ever stroke, the duration after stroke exceeds 12 months;
• mild to moderate upper extremity motor function deficit, determined by the Fugl-meyer assessment of upper extremity (FMAUE) scores between 15 and 53;
• detectable voluntary muscle sEMG signal from flexor digitorum (FD) and extensor digitorum (ED);
• scored below 3 in the Modified Ashworh Score (MAS) of FD and ED;
• sufficient cognitive function to follow the assessment and training instructions, determined by Mini Mental State Examination score of more than 21.

Read More

Exclusion Criteria

• history of epilepsy, or any other contradictions of brain stimulation;
• severe joint contracture of elbow or shoulder, or pain induced by any other neurological, neuromuscular, and orthopedic diseases.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
multisite HD-tDCS with EMG-driven robot hand group	multisite HD-tDCS EMG-driven robot hand	The stimulation electrodes are fixed on the ipsilesional sensorimotor cortex according to the brain activation map detected by task based fMRI.
Sham HD-tDCS EMG-driven robot hand group	Sham HD-tDCS EMG-driven robot hand	The stimulator will be applied for 20 minutes with only 30s ramp-up and ramp-down stimulation delivered.

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment Upper Extremity	6-month after intervention	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

Secondary Outcome Measures

Name	Time	Method
Action Research Arm Test	6-month after intervention	The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement) to assess upper limb functioning
Magnetic Resonance Imaging (MRI)	6-month after intervention	It is used to identify neural correlates of stimulation-induced behavioral gains for investigating tDCS-induced changes in brain activations
Electroencephalography (EEG)	6-month after intervention	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.
Electromyography (EMG)	6-month after intervention	EMG will be used to detect muscle activation change and muscle co-contraction pattern alteration.

Trial Locations

Locations (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong