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Effect of Multisite High-definition Transcranial Direct Current Stimulation Targeting Sensorimotor Network

Multisite High-definition Transcranial Direct Current Stimulation Targeting Sensorimotor Network Navigated by Task-based fMRI to Facilitate Motor Activation and Reorganization for Stroke

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06648954
Enrollment
30
Registered
2024-10-18
Start date
2022-08-13
Completion date
2024-12-31
Last updated
2024-10-18

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

Conditions

Stroke

Brief summary

Transcranial direct current stimulation (tDCS) has been applied to facilitate cortical excitability in stroke populations, as increasing evidence suggests that clinical recovery from stroke is attributed to neuroplastic reorganization. However, recovery from stroke following this kind of non-invasive neuromodulation remains divergent across stroke patients due to variations in their etiologies, lesion profiles and post-stroke duration. A novel multisite high definition tDCS (HD-tDCS) in healthy people showed that such network-targeted stimulation could enhance motor excitability beyond conventional stimulation which targeting only one region. The electrode placements could be determined by the montage optimization, which targets individual motor network activation navigated by task-based fMRI using computation algorithms. By targeting motor network, the new multisite electrode montage may provide a potential to facilitate better cortical activation than conventional tDCS montage.

Detailed description

Transcranial direct current stimulation (tDCS) has been applied to facilitate cortical excitability in stroke populations, as increasing evidence suggests that clinical recovery from stroke is attributed to neuroplastic reorganization. However, recovery from stroke following this kind of non-invasive neuromodulation remains divergent across stroke patients due to variations in their etiologies, lesion profiles and post-stroke durations. In the stroke application of tDCS, most non-invasive brain stimulation studies have mainly focused on the modulation of the primary motor cortex (M1) in motor skill relearning. Previous studies have shown that not only the M1, which is the most important area associated with the motor system, but also other secondary motor areas (e.g., premotor cortex (PM) and supplementary motor area (SMA)) can be influenced by the onset of stroke. In fact, SMA activations and shifts in the M1 are commonly observed in stroke patients. However, brain regions do not operate in isolation, but communicate and interact with other discrete regions through networks. Conventional stimulations of one region (normally the M1 in stroke) have neglected the network impact and the changed motor network composition after stroke, which is often limited in stroke rehabilitation. A novel multisite high definition tDCS (HD-tDCS) in healthy people showed that such network-targeted stimulation could enhance motor excitability beyond conventional 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 and the different activation patterns of individual stroke survivors, personalized lesion profiles and anatomical features can be determined using finite element modelling, with lesion profiles generated from MRI and advanced algorithms calculating the current density to maximize the modulation effect. The electrode placements could be determined by the montage optimization, which targets individual motor network activation navigated by task-based fMRI using computation algorithms. By targeting motor network, the new multisite electrode montage may provide a potential to facilitate better cortical activation than conventional tDCS montage. In this study, A randomized cross-over designed trial will be conducted to explore motor activation and reorganization changes before and after multisite HD-tDCS, conventional tDCS, and sham tDCS in stroke survivors. The stimulation effect will be evaluated by fMRI.

Interventions

DEVICEmultisite HD-tDCS

5-8 MRI compatible electrodes (2 cm diameter) will be placed based on the neuroimaging and computation modelling. The electrodes will be placed inside MRI compatible sponges and affixed to the head using a device matched cap which will be filled with saline to have good contact with the scalp.

A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.

DEVICESham stimulation

5-8 MRI compatible electrodes (2 cm diameter) will be placed based on the neuroimaging and computation modelling. The electrodes will be placed inside MRI compatible sponges and affixed to the head using a device matched cap which will be filled with saline to have good contact with the scalp.

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
Healthy volunteers
Yes

Inclusion criteria

1. first-ever stroke, the duration after stroke exceeds 12 months; 2. mild to moderate upper extremity motor function deficit, determined by the Fugl-meyer assessment of upper extremity (FMAUE) scores between 15 and 53; 3. could voluntarily perform grasping hand movement. 4. sufficient cognitive function to follow the assessment and experiment instructions.

Exclusion criteria

1. history of epilepsy, or any other contradictions of brain stimulation and MRI scanning; 2. severe joint contracture of elbow or shoulder, or pain induced by any other neurological, neuromuscular, and orthopedic diseases.

Design outcomes

Primary

MeasureTime frameDescription
Resting-state functional connectivitybefore and immediately after stimulationFunctional magnetic resonance imaging for collecting BOLD signals during resting-state.

Secondary

MeasureTime frameDescription
Fugl-Meyer Assessmentbefore experimentMotor function assessment for stroke survivors
task-based brain activationbefore and immediately after stimulationFunctional magnetic resonance imaging for collecting BOLD signals during motor tasks.

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 4, 2026