Multisite Transcranial Direct Current Stimulation to Promote Hand Function Recovery After Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: multisite HD-tDCS EMG-driven robot hand, Sham HD-tDCS EMG-driven robot hand.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multisite Transcranial Direct Current Stimulation Targeting Motor Network by Mapping Electric Fields With Task-based fMRI to Promote Hand Function Recovery After Stroke
Overview
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
- Device multisite 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 indi - Device Sham 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.
Primary outcome measures
- Fugl-Meyer Assessment Upper Extremity [Time frame: 6-month after intervention]
Secondary outcome measures (4)
- Action Research Arm Test [Time frame: 6-month after intervention]
- Magnetic Resonance Imaging (MRI) [Time frame: 6-month after intervention]
- Electroencephalography (EEG) [Time frame: 6-month after intervention]
- Electromyography (EMG) [Time frame: 6-month after intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Department of Biomedical Engineering, The Chinese University of Hong Kong — Hong Kong
Publications
- Hu C, Ti CHE, Yuan K, Chen C, Khan A, Shi X, Chu WC, Tong RK. Effects of high-definition tDCS targeting individual motor hotspot with EMG-driven robotic hand training on upper extremity motor function: a pilot randomized controlled trial. J Neuroeng Rehabil. 2024 Sep 20;21(1):169. doi: 10.1186/s12984-024-01468-w. PMID 39304930
Identifiers
NCT: NCT05638464 · 2018.661