StrokeNCT06648954
Effect of Multisite High-definition Transcranial Direct Current Stimulation Targeting Sensorimotor Network
A study testing multisite HD-tDCS and Conventional tDCS in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Transcranial direct current stimulation (tDCS) has been applied to facilitate cortical excitability in stroke populations, as increasing evidence suggests that clinical recovery from stroke is attributed to neuroplastic reorganization. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- multisite HD-tDCS and Conventional 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
- 13 Aug 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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;
- could voluntarily perform grasping hand movement.
- sufficient cognitive function to follow the assessment and experiment instructions.
Who cannot join
- history of epilepsy, or any other contradictions of brain stimulation and MRI scanning;
- severe joint contracture of elbow or shoulder, or pain induced by any other neurological, neuromuscular, and orthopedic diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Biomedical Engineering, The Chinese University of Hong Kong
Hong Kong
Raymond Kai-yu Tong, PhD, +852 3943 8454, kytong@cuhk.edu.hk
Raymond Kai-yu Tong, PhD
About this study
Official title: Multisite High-definition Transcranial Direct Current Stimulation Targeting Sensorimotor Network Navigated by Task-based fMRI to Facilitate Motor Activation and Reorganization for Stroke
Transcranial direct current stimulation (tDCS) has been applied to facilitate cortical excitability in stroke populations, as increasing evidence suggests that clinical recovery from stroke is attributed to neuroplastic reorganization. However, recovery from stroke following this kind of non-invasive neuromodulation remains divergent across stroke patients due to variations in their etiologies, lesion profiles and post-stroke duration.
A novel multisite high definition tDCS (HD-tDCS) in healthy people showed that such network-targeted stimulation could enhance motor excitability beyond conventional stimulation which targeting only one region. The electrode placements could be determined by the montage optimization, which targets individual motor network activation navigated by task-based fMRI using computation algorithms.
By targeting motor network, the new multisite electrode montage may provide a potential to facilitate better cortical activation than conventional tDCS montage.
Read the detailed description
Transcranial direct current stimulation (tDCS) has been applied to facilitate cortical excitability in stroke populations, as increasing evidence suggests that clinical recovery from stroke is attributed to neuroplastic reorganization. However, recovery from stroke following this kind of non-invasive neuromodulation remains divergent across stroke patients due to variations in their etiologies, lesion profiles and post-stroke durations. In the stroke application of tDCS, most non-invasive brain stimulation studies have mainly focused on the modulation of the primary motor cortex (M1) in motor skill relearning. Previous studies have shown that not only the M1, which is the most important area associated with the motor system, but also other secondary motor areas (e.g., premotor cortex (PM) and supplementary motor area (SMA)) can be influenced by the onset of stroke. In fact, SMA activations and shifts in the M1 are commonly observed in stroke patients. However, brain regions do not operate in isolation, but communicate and interact with other discrete regions through networks. Conventional stimulations of one region (normally the M1 in stroke) have neglected the network impact and the changed motor network composition after stroke, which is often limited in stroke rehabilitation. A novel multisite high definition tDCS (HD-tDCS) in healthy people showed that such network-targeted stimulation could enhance motor excitability beyond conventional 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 and the different activation patterns of individual stroke survivors, personalized lesion profiles and anatomical features can be determined using finite element modelling, with lesion profiles generated from MRI and advanced algorithms calculating the current density to maximize the modulation effect. The electrode placements could be determined by the montage optimization, which targets individual motor network activation navigated by task-based fMRI using computation algorithms. By targeting motor network, the new multisite electrode montage may provide a potential to facilitate better cortical activation than conventional tDCS montage.
In this study, A randomized cross-over designed trial will be conducted to explore motor activation and reorganization changes before and after multisite HD-tDCS, conventional tDCS, and sham tDCS in stroke survivors. The stimulation effect will be evaluated by fMRI.
- Conditions
- Stroke
- Being tested
- multisite HD-tDCS, Conventional tDCS, Sham stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multisite HD-tDCSDevice
5-8 MRI compatible electrodes (2 cm diameter) will be placed based on the neuroimaging and computation modelling. The electrodes will be placed inside MRI compatible sponges and affixed to the head using a device matched cap which will be filled with saline to have good contact with the scalp.
Conventional tDCSDevice
A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.
Sham stimulationDevice
5-8 MRI compatible electrodes (2 cm diameter) will be placed based on the neuroimaging and computation modelling. The electrodes will be placed inside MRI compatible sponges and affixed to the head using a device matched cap which will be filled with saline to have good contact with the scalp.
| Study group | Role | What they receive |
|---|---|---|
| Multisite HD-tDCS group | Experimental | Device:
Constant current will be applied for 20min and the electrodes will be placed over the target area Receives: Device: multisite HD-tDCS |
| Sham stimulation group | Sham comparator | The stimulator will be applied for 20 minutes with only 30s ramp-up and ramp-down stimulation delivered. The patients will feel the initial itching sensation at the beginning in order to evaluate the placebo effect. Receives: Device: Sham stimulation |
| Conventional tDCS Group | Active comparator | Constant current (2mA) will be applied for 20min and the anode will be placed over the standard C3/C4 position. Receives: Device: Conventional tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting-state functional connectivity
Functional magnetic resonance imaging for collecting BOLD signals during resting-state.
Measured: before and immediately after stimulation
Secondary outcomes (2)
Fugl-Meyer Assessment
Motor function assessment for stroke survivors
Measured: before experiment
task-based brain activation
Functional magnetic resonance imaging for collecting BOLD signals during motor tasks.
Measured: before and immediately after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start13 Aug 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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
- Parallel groups
- 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
- NCT06648954
- Sponsor's protocol ID
- 2018.661b
- Status last verified
- Oct 2024
- First submitted
- 15 Sep 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisite High-definition Transcranial Direct Current Stimulation Targeting Sensorimotor Network Navigated by Task-based fMRI to Facilitate Motor Activation and Reorganization for Stroke
- ClinicalTrials.gov ID
- NCT06648954
- Acronym / sponsor ID
- 2018.661b
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 13 Aug 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Oct 2024 (actual)
- 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.
Transcranial direct current stimulation (tDCS) has been applied to facilitate cortical excitability in stroke populations, as increasing evidence suggests that clinical recovery from stroke is attributed to neuroplastic reorganization. However, recovery from stroke following this kind of non-invasive neuromodulation remains divergent across stroke patients due to variations in their etiologies, lesion profiles and post-stroke duration.
A novel multisite high definition tDCS (HD-tDCS) in healthy people showed that such network-targeted stimulation could enhance motor excitability beyond conventional stimulation which targeting only one region. The electrode placements could be determined by the montage optimization, which targets individual motor network activation navigated by task-based fMRI using computation algorithms.
By targeting motor network, the new multisite electrode montage may provide a potential to facilitate better cortical activation than conventional tDCS montage.
Detailed description
Transcranial direct current stimulation (tDCS) has been applied to facilitate cortical excitability in stroke populations, as increasing evidence suggests that clinical recovery from stroke is attributed to neuroplastic reorganization. However, recovery from stroke following this kind of non-invasive neuromodulation remains divergent across stroke patients due to variations in their etiologies, lesion profiles and post-stroke durations. In the stroke application of tDCS, most non-invasive brain stimulation studies have mainly focused on the modulation of the primary motor cortex (M1) in motor skill relearning. Previous studies have shown that not only the M1, which is the most important area associated with the motor system, but also other secondary motor areas (e.g., premotor cortex (PM) and supplementary motor area (SMA)) can be influenced by the onset of stroke. In fact, SMA activations and shifts in the M1 are commonly observed in stroke patients. However, brain regions do not operate in isolation, but communicate and interact with other discrete regions through networks. Conventional stimulations of one region (normally the M1 in stroke) have neglected the network impact and the changed motor network composition after stroke, which is often limited in stroke rehabilitation. A novel multisite high definition tDCS (HD-tDCS) in healthy people showed that such network-targeted stimulation could enhance motor excitability beyond conventional 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 and the different activation patterns of individual stroke survivors, personalized lesion profiles and anatomical features can be determined using finite element modelling, with lesion profiles generated from MRI and advanced algorithms calculating the current density to maximize the modulation effect. The electrode placements could be determined by the montage optimization, which targets individual motor network activation navigated by task-based fMRI using computation algorithms. By targeting motor network, the new multisite electrode montage may provide a potential to facilitate better cortical activation than conventional tDCS montage.
In this study, A randomized cross-over designed trial will be conducted to explore motor activation and reorganization changes before and after multisite HD-tDCS, conventional tDCS, and sham tDCS in stroke survivors. The stimulation effect will be evaluated by fMRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multisite HD-tDCS group | Experimental | Device: multisite HD-tDCSDevice: Constant current will be applied for 20min and the electrodes will be placed over the target area |
| Sham stimulation group | Sham comparator | Device: Sham stimulationThe stimulator will be applied for 20 minutes with only 30s ramp-up and ramp-down stimulation delivered. The patients will feel the initial itching sensation at the beginning in order to evaluate the placebo effect. |
| Conventional tDCS Group | Active comparator | Device: Conventional tDCSConstant current (2mA) will be applied for 20min and the anode will be placed over the standard C3/C4 position. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
- could voluntarily perform grasping hand movement.
- sufficient cognitive function to follow the assessment and experiment instructions.
Key exclusion criteria (2 listed)
- history of epilepsy, or any other contradictions of brain stimulation and MRI scanning;
- severe joint contracture of elbow or shoulder, or pain induced by any other neurological, neuromuscular, and orthopedic diseases.
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 |
|---|---|---|
| multisite HD-tDCS5-8 MRI compatible electrodes (2 cm diameter) will be placed based on the neuroimaging and computation modelling. The electrodes will be placed inside MRI compatible sponges and affixed to the head using a device matched cap which will be filled with saline to have good contact with the scalp. | Device | Multisite HD-tDCS group |
| Conventional tDCSA pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands. | Device | Conventional tDCS Group |
| Sham stimulation5-8 MRI compatible electrodes (2 cm diameter) will be placed based on the neuroimaging and computation modelling. The electrodes will be placed inside MRI compatible sponges and affixed to the head using a device matched cap which will be filled with saline to have good contact with the scalp. | Device | Sham stimulation group |
Primary outcome
Resting-state functional connectivity
Time frame: before and immediately after stimulation
Functional magnetic resonance imaging for collecting BOLD signals during resting-state.
2 secondary outcomes
Fugl-Meyer Assessment
Time frame: before experiment
task-based brain activation
Time frame: before and immediately after stimulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
Related trials for Stroke
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
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.
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 multisite HD-tDCS and Conventional 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 18 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Resting-state functional connectivity (time frame: before and immediately after stimulation). 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 18 Oct 2024; AzTrials last refreshed its copy on 31 Oct 2026.