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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-13

Study Completion Date

2024-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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multisite HD-tDCS with EMG-driven robot hand group

The stimulation electrodes are fixed on the ipsilesional sensorimotor cortex according to the brain activation map detected by task based fMRI.

Group Type EXPERIMENTAL

multisite HD-tDCS EMG-driven robot hand

Intervention Type 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 group

The stimulator will be applied for 20 minutes with only 30s ramp-up and ramp-down stimulation delivered.

Group Type SHAM_COMPARATOR

Sham HD-tDCS EMG-driven robot hand

Intervention Type 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.

Interventions

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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 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes