NCT02960009

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

6.5 years

First QC Date

September 14, 2016

Last Update Submit

November 16, 2022

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

  • 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.

    Before intervention, During intervention, After intervention, 6-month after intervention

  • 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

    Before intervention, After intervention, 6-month after intervention

  • 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

    Before intervention, After intervention, 6-month after intervention

Secondary Outcomes (2)

  • Magnetic Resonance Imaging (MRI)

    Before intervention, After intervention, 6-month after intervention

  • Transcranial Magnetic Stimulation (TMS)

    Before intervention

Study Arms (3)

Anode HD-tDCS

EXPERIMENTAL

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.

Device: HD-tDCS

Cathode HD-tDCS

EXPERIMENTAL

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.

Device: HD-tDCS

Sham HD-tDCS

PLACEBO COMPARATOR

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.

Device: HD-tDCS

Interventions

HD-tDCSDEVICE

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.

Anode HD-tDCSCathode HD-tDCSSham HD-tDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Raymond Kai-yu Tong, PhD

    Department of Biomedical Engineering, CUHK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Kai-yu Tong, PhD

CONTACT

+852 3943 8454kytong@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 14, 2016

First Posted

November 9, 2016

Study Start

June 20, 2016

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)