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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Stroke

Treatments: Device: multisite HD-tDCS EMG-driven robot hand; Device: Sham HD-tDCS EMG-driven robot hand

Study type: Interventional

Funder types: Other

Identifiers

NCT05638464

2018.661

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

multisite HD-tDCS with EMG-driven robot hand group

Experimental group

Description:

The stimulation electrodes are fixed on the ipsilesional sensorimotor cortex according to the brain activation map detected by task based fMRI.

Treatment:

Device: multisite HD-tDCS EMG-driven robot hand

Sham HD-tDCS EMG-driven robot hand group

Sham Comparator group

Description:

The stimulator will be applied for 20 minutes with only 30s ramp-up and ramp-down stimulation delivered.

Treatment:

Device: Sham HD-tDCS EMG-driven robot hand