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

Multisite Transcranial Direct Current Stimulation Targeting Motor Network by Mapping Electric Fields With Task-based fMRI to Promote Hand Function Recovery After Stroke

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05638464
Enrollment
50
Registered
2022-12-06
Start date
2021-08-13
Completion date
2024-12-31
Last updated
2024-09-03

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

Conditions

Stroke

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.

Interventions

DEVICEmultisite HD-tDCS EMG-driven robot hand

Multisite HD-tDCS will individual stimulation montages with robot hand training will be applied on chronic stroke survivors. In the multisite HD-tDCS group, 5-8 sintered Ag/AgCl ring electrodes will be placed based on the neuroimaging and computation modelling. The location of the electrodes will be identified by the individual brain activity in the primary motor cortex derived from tasked-based fMRI. The Finite Element Model (FEM) will be used to simulate the electric field distribution on individual brain. Optimization of stimulation montages will be based on the derived activation pattern of the brain. After 20-minute multisite HD-tDCS, EMG-driven robot hand training will be conducted.

DEVICESham HD-tDCS EMG-driven robot hand

Sham stimulation with robot hand training will be applied on chronic stroke survivors. After the sham stimulation, EMG-driven robot hand training will be conducted.

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

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

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer Assessment Upper Extremity6-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
Action Research Arm Test6-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
Magnetic Resonance Imaging (MRI)6-month after interventionIt is used to identify neural correlates of stimulation-induced behavioral gains for investigating tDCS-induced changes in brain activations
Electroencephalography (EEG)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.
Electromyography (EMG)6-month after interventionEMG will be used to detect muscle activation change and muscle co-contraction pattern alteration.

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 5, 2026