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NCT Number: NCT05638464

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong

Location status: Recruiting

Location contact

Raymond Tong, PhD

CONTACT

+852 3943 8454

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

multisite HD-tDCS EMG-driven robot hand

Device

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 HD-tDCS EMG-driven robot hand

Device

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 outcomes

  1. Fugl-Meyer Assessment Upper Extremity

    Time frame: 6-month after intervention

    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

Secondary outcomes

  1. Action Research Arm Test

    Time frame: 6-month after intervention

    The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement) to assess upper limb functioning

  2. Magnetic Resonance Imaging (MRI)

    Time frame: 6-month after intervention

    It is used to identify neural correlates of stimulation-induced behavioral gains for investigating tDCS-induced changes in brain activations

  3. Electroencephalography (EEG)

    Time frame: 6-month after intervention

    It is used to investigate the changes in corticomuscular coherence for studying connectivity between the brainwave using EEG and the affected hand muscles using EMG.

  4. Electromyography (EMG)

    Time frame: 6-month after intervention

    EMG will be used to detect muscle activation change and muscle co-contraction pattern alteration.

Study contacts

Contact information is provided by the study sponsor or research team.

Raymond Kai-yu Tong, PhD

CONTACT

[email protected]

+852 3943 8454

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2022
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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