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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
multisite HD-tDCS
Conventional tDCS
multisite HD-tDCS EMG-driven robot hand
Sham HD-tDCS EMG-driven robot hand
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Biomedical Engineering, The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Sham Comparator

Experimental

Sham Comparator

Arm Label

Multisite HD-tDCS group

Conventional tDCS Group

Sham HD-tDCS group

multisite HD-tDCS with EMG-driven robot hand group

Sham HD-tDCS EMG-driven robot hand group

Arm Description

Constant current will be applied for 20min and the electrodes will be placed over the target area

Constant current (1mA) will be applied for 20min and the anode will be placed over the standard C3/C4 position

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

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

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

Outcomes

Primary Outcome Measures

Action Research Arm Test
The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement) to assess upper limb functioning
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
Electroencephalography (EEG) and Electromyography (EMG)
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. In addition, EMG will be used to detect muscle activation change and muscle co-contraction pattern alteration.
Magnetic Resonance Imaging (MRI)
It is used to identify neural correlates of stimulation-induced behavioral gains for investigating tDCS-induced changes in brain activations

Secondary Outcome Measures

Full Information

First Posted
November 16, 2022
Last Updated
November 27, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05638464
Brief Title
Multisite Transcranial Direct Current Stimulation to Promote Hand Function Recovery After Stroke
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 13, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multisite HD-tDCS group
Arm Type
Experimental
Arm Description
Constant current will be applied for 20min and the electrodes will be placed over the target area
Arm Title
Conventional tDCS Group
Arm Type
Active Comparator
Arm Description
Constant current (1mA) will be applied for 20min and the anode will be placed over the standard C3/C4 position
Arm Title
Sham HD-tDCS group
Arm Type
Sham Comparator
Arm Description
The stimulator will be applied for 20 minutes with only 30s ramp-up and ramp-down stimulation delivered.
Arm Title
multisite HD-tDCS with EMG-driven robot hand group
Arm Type
Experimental
Arm Description
The stimulation electrodes are fixed on the ipsilesional sensorimotor cortex according to the brain activation map detected by task based fMRI.
Arm Title
Sham HD-tDCS EMG-driven robot hand group
Arm Type
Sham Comparator
Arm Description
The stimulator will be applied for 20 minutes with only 30s ramp-up and ramp-down stimulation delivered.
Intervention Type
Device
Intervention Name(s)
multisite HD-tDCS
Intervention Description
5-8 sintered Ag/AgCl ring electrodes will be placed based on the neuroimaging and computation modelling. The electrodes will be placed inside plastic electrode holders which will be filled with gel to have good contact with the scalp.
Intervention Type
Device
Intervention Name(s)
Conventional tDCS
Intervention Description
A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.
Intervention Type
Device
Intervention Name(s)
multisite HD-tDCS EMG-driven robot hand
Intervention Description
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
Intervention Name(s)
Sham HD-tDCS EMG-driven robot hand
Intervention Description
Sham stimulation with robot hand training will be applied on chronic stroke survivors. A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands. After the sham stimulation, EMG-driven robot hand training will be conducted.
Primary Outcome Measure Information:
Title
Action Research Arm Test
Description
The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement) to assess upper limb functioning
Time Frame
6-month after intervention
Title
Fugl-Meyer Assessment Upper Extremity
Description
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
Time Frame
6-month after intervention
Title
Electroencephalography (EEG) and Electromyography (EMG)
Description
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. In addition, EMG will be used to detect muscle activation change and muscle co-contraction pattern alteration.
Time Frame
6-month after intervention
Title
Magnetic Resonance Imaging (MRI)
Description
It is used to identify neural correlates of stimulation-induced behavioral gains for investigating tDCS-induced changes in brain activations
Time Frame
6-month after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Kai-yu Tong, PhD
Phone
+852 3943 8454
Email
kytong@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Kai-yu Tong, PhD
Organizational Affiliation
Department of Biomedical Engineering, CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biomedical Engineering, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Tong, PhD
Phone
+852 3943 8454

12. IPD Sharing Statement

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

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