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Motor Excitability Study of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Chronic Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
HD-tDCS
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:

  1. Sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment;
  2. Have moderate to severe motor disability at the paretic upper limb (assessed by Fugl-Meter Assessment (FMA), and Action Research Arm Test (ARAT));
  3. Hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection

Exclusion Criteria:

  1. Severe hand spasticity, open hand wound or hand deformity;
  2. Visual field deficits;
  3. Aphasia, neglect, and apraxia;
  4. History of alcohol, drug abuse or epilepsy;
  5. Bilateral infracts;
  6. Uncontrolled medical problems;
  7. Serious cognitive deficits [Mini-Mental State Examination (MMSE) < 21];
  8. Major depression
  9. Metal implants inside body
  10. MRI, TMS and tDCS contraindications

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Anode HD-tDCS

Cathode HD-tDCS

Sham HD-tDCS

Arm Description

The center anode is fixed on the ipsilesional primary motor cortex and the 4 surrounding cathode electrodes will be placed about 6 cm to the center.

The center cathode is fixed on the contralesional primary motor cortex and the 4 surrounding anode electrodes will be placed about 6 cm to the center.

The center anode is fixed on the ipsilesional primary motor cortex and the 4 surrounding cathode electrodes will be placed about 6 cm to the center.

Outcomes

Primary Outcome Measures

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.
Action Research Arm Test (ARAT)
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 (FMA-UE)
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 Outcome Measures

Magnetic Resonance Imaging (MRI)
It is used to identify neural correlates of stimulation-induced behavioral gains for investigating tDCS-induced changes in brain activations
Transcranial Magnetic Stimulation (TMS)
It is used to measure the changes in interhemispheric imbalance and corticospinal excitability

Full Information

First Posted
September 14, 2016
Last Updated
November 16, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02960009
Brief Title
Motor Excitability Study of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Chronic Stroke
Official Title
Motor Excitability Study of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2016 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (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
High definition tDCS will be conducted to both stroke and healthy subjects on primary motor cortex area to explore the motor excitability changes before and after stimulation. In next stage, a randomized control trial with 20-session training will be conducted to evaluate the effectiveness of transient modulation of cortical excitability through multisite HD-tDCS with EMG driven robot hand training, a sham stimulation with EMG-driven robot hand training will be applied as control group.

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
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anode HD-tDCS
Arm Type
Experimental
Arm Description
The center anode is fixed on the ipsilesional primary motor cortex and the 4 surrounding cathode electrodes will be placed about 6 cm to the center.
Arm Title
Cathode HD-tDCS
Arm Type
Experimental
Arm Description
The center cathode is fixed on the contralesional primary motor cortex and the 4 surrounding anode electrodes will be placed about 6 cm to the center.
Arm Title
Sham HD-tDCS
Arm Type
Placebo Comparator
Arm Description
The center anode is fixed on the ipsilesional primary motor cortex and the 4 surrounding cathode electrodes will be placed about 6 cm to the center.
Intervention Type
Device
Intervention Name(s)
HD-tDCS
Intervention Description
Different stimulation protocols will be applied to the primary motor cortex of stroke patients. After 20-minute stimulation, EMG-driven robot hand training will be conducted.
Primary Outcome Measure Information:
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
Before intervention, During intervention, After intervention, 6-month after intervention
Title
Action Research Arm Test (ARAT)
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
Before intervention, After intervention, 6-month after intervention
Title
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
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
Before intervention, After intervention, 6-month after intervention
Secondary Outcome Measure Information:
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
Before intervention, After intervention, 6-month after intervention
Title
Transcranial Magnetic Stimulation (TMS)
Description
It is used to measure the changes in interhemispheric imbalance and corticospinal excitability
Time Frame
Before intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment; Have moderate to severe motor disability at the paretic upper limb (assessed by Fugl-Meter Assessment (FMA), and Action Research Arm Test (ARAT)); Hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection Exclusion Criteria: Severe hand spasticity, open hand wound or hand deformity; Visual field deficits; Aphasia, neglect, and apraxia; History of alcohol, drug abuse or epilepsy; Bilateral infracts; Uncontrolled medical problems; Serious cognitive deficits [Mini-Mental State Examination (MMSE) < 21]; Major depression Metal implants inside body MRI, TMS and tDCS contraindications
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

Plan to Share IPD
No

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Motor Excitability Study of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Chronic Stroke

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