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

NCT ID: NCT02960009

Last Updated: 2022-11-21

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-20

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Anode HD-tDCS

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.

Group Type EXPERIMENTAL

HD-tDCS

Intervention Type DEVICE

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.

Cathode HD-tDCS

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.

Group Type EXPERIMENTAL

HD-tDCS

Intervention Type DEVICE

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.

Sham HD-tDCS

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.

Group Type PLACEBO_COMPARATOR

HD-tDCS

Intervention Type DEVICE

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.

Interventions

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HD-tDCS

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Raymond KY Tong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raymond Kai-yu Tong, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Biomedical Engineering, CUHK

Locations

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Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Raymond Kai-yu Tong, PhD

Role: CONTACT

+852 3943 8454

Facility Contacts

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Raymond Tong, PhD

Role: primary

+852 3943 8454

Other Identifiers

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2015.691-T

Identifier Type: -

Identifier Source: org_study_id

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