StrokeNCT02960009
Motor Excitability Study of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Chronic Stroke
A study testing HD-tDCS in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- HD-tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Jun 2016to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- Serious cognitive deficits [Mini-Mental State Examination (MMSE) < 21];
- Major depression
- Metal implants inside body
- MRI, TMS and tDCS contraindications
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Biomedical Engineering, The Chinese University of Hong Kong
Hong Kong
Raymond Tong, PhD, +852 3943 8454
About this study
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.
- Conditions
- Stroke
- Being tested
- HD-tDCS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: HD-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Before intervention, After intervention, 6-month after intervention
Secondary outcomes (2)
Magnetic Resonance Imaging (MRI)
It is used to identify neural correlates of stimulation-induced behavioral gains for investigating tDCS-induced changes in brain activations
Measured: Before intervention, After intervention, 6-month after intervention
Transcranial Magnetic Stimulation (TMS)
It is used to measure the changes in interhemispheric imbalance and corticospinal excitability
Measured: Before intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start20 Jun 2016
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond KY Tong, Chinese University of Hong Kong
- Investigators
- Raymond Kai-yu Tong, PhD, Principal investigator, Department of Biomedical Engineering, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960009
- Sponsor's protocol ID
- 2015.691-T
- Status last verified
- Nov 2022
- First submitted
- 14 Sep 2016
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Excitability Study of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Chronic Stroke
- ClinicalTrials.gov ID
- NCT02960009
- Acronym / sponsor ID
- 2015.691-T
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 20 Jun 2016 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anode HD-tDCS | Experimental | Device: HD-tDCSThe 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. |
| Cathode HD-tDCS | Experimental | Device: HD-tDCSThe 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. |
| Sham HD-tDCS | Placebo comparator | Device: HD-tDCSThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HD-tDCSDifferent 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. | Device | Anode HD-tDCS, Cathode HD-tDCS, Sham HD-tDCS |
Primary outcome
Electroencephalography (EEG) and Electromyography (EMG)
Time frame: Before intervention, During intervention, After intervention, 6-month after intervention
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)
Time frame: Before intervention, After intervention, 6-month after intervention
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)
Time frame: Before intervention, After intervention, 6-month after intervention
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
2 secondary outcomes
Magnetic Resonance Imaging (MRI)
Time frame: Before intervention, After intervention, 6-month after intervention
Transcranial Magnetic Stimulation (TMS)
Time frame: Before intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Kai-yu Tong, PhD principal investigator
Department of Biomedical Engineering, CUHK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD-tDCS in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raymond Kai-yu Tong, PhD (+852 3943 8454, kytong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalography (EEG) and Electromyography (EMG) (time frame: Before intervention, During intervention, After intervention, 6-month after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.