Multisite Transcranial Direct Current Stimulation to Promote Hand Function Recovery After Stroke
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Aug 2021
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 13, 2021
CompletedFirst Submitted
Initial submission to the registry
November 16, 2022
CompletedFirst Posted
Study publicly available on registry
December 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedSeptember 3, 2024
August 1, 2024
3.3 years
November 16, 2022
August 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Fugl-Meyer Assessment Upper Extremity
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
6-month after intervention
Secondary Outcomes (4)
Action Research Arm Test
6-month after intervention
Magnetic Resonance Imaging (MRI)
6-month after intervention
Electroencephalography (EEG)
6-month after intervention
Electromyography (EMG)
6-month after intervention
Study Arms (2)
multisite HD-tDCS with EMG-driven robot hand group
EXPERIMENTALThe 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 COMPARATORThe stimulator will be applied for 20 minutes with only 30s ramp-up and ramp-down stimulation delivered.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Biomedical Engineering, The Chinese University of Hong Kong
Hong Kong, Hong Kong
Related Publications (1)
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: 39304930DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raymond Kai-yu Tong, PhD
Department of Biomedical Engineering, CUHK
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chairman
Study Record Dates
First Submitted
November 16, 2022
First Posted
December 6, 2022
Study Start
August 13, 2021
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
September 3, 2024
Record last verified: 2024-08