StrokeNCT06503484
fNIRS-BCI Neurofeedback in Stroke Rehabilitation
A study testing Brain-computer interface in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Objectives: 1) To compare the effects of closed-loop brain-computer interface (BCI) driven observational imitation training versus sham BCI open-loop observational imitation training on improving upper limb motor functions in patients with stroke; 2) To investigate whether stroke patients receiving closed-loop… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Brain-computer interface
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Dec 2024to 31 Dec 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral upper extremity motor deficits caused by ischemic stroke, confirmed by medical documents such as discharge summary and/or neuroimaging examinations.
- chronic phase of stroke, i.e., time after stroke onset more than six months.
- aged between 18 and 75 years old.
- with mildly-to-moderately impaired upper limb functional activity that is stratified according to the levels 3-7 in the Functional Test for the Hemiplegic Upper Extremity.
- able to give informed written consent to participate in the study.
- able to read and understand traditional Chinese.
Who cannot join
- previous diagnosis of any neurological disease excluding ischemic stroke.
- presence of any sign of cognitive problems (The Montreal cognitive assessment Hong Kong version<22/30).
- Severe spasticity measured by the Modified Ashworth Scale score>2 in the hand, wrist or elbow extensor muscle in the hemiparetic upper extremity.
- with other notable impairments of the upper limb not caused by stroke (e.g., bone fracture in the past year, congenital deformity, or other impairments).
- current participation in any other treatment programme or clinical study involving exercise, non-invasive brain stimulation, or BCI/neurofeedback.
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
Jack Jiaqi Zhang
Hong Kong, Hong Kong, 000000
Jack Jiaqi Zhang, PhD, 27666696, jack-jiaqi.zhang@polyu.edu.hk
Sofina Chan, MA, sofina.chan@connect.polyu.hk
About this study
Official title: Utilizing a Brain-Computer Interface for Observational Imitation Training to Enhance Upper Limb Motor Recovery Post-Stroke: A Randomized Controlled Trial
Objectives: 1) To compare the effects of closed-loop brain-computer interface (BCI) driven observational imitation training versus sham BCI open-loop observational imitation training on improving upper limb motor functions in patients with stroke; 2) To investigate whether stroke patients receiving closed-loop training exhibit higher activation levels in the mirror neurons, measured by event-related desynchronization (ERD), compared to those receiving open-loop training.
Hypothesis to be tested: The closed-loop training is more effective than open-loop training in improving upper limb motor outcomes, and there is an increase in the mirror neurons activity in those receiving closed-loop training.
Read more
Design and subjects: A randomized controlled trial with 44 participants with stroke.
Study instruments: Functional near-infrared spectroscopy (fNIRS)-based BCI and electroencephalography (EEG).
Interventions: In the BCI training, participants will engage in kinesthetic motor imagery. When the M1 activation level recorded by fNIRS surpasses a predefined threshold, participants will receive visual feedback to guide them to imitate the movement. However, for participants in the sham BCI group, the visual feedback will be given will be given constantly. Both types of training consist of ten sessions.
Main outcome measures: Upper limb motor tests and the activity of mirror neurons measured by sensorimotor ERD using EEG.
Data analysis: Analysis of variance and correlation. Expected results: The closed-loop BCI-driven observational imitation training is more effective than sham BCI open-loop training on enhancing hemiplegic upper limb functions and the activation of the mirror neurons in patients after stroke.
Read the detailed description
Objectives: 1) To compare the effects of closed-loop brain-computer interface (BCI) driven observational imitation training versus sham BCI open-loop observational imitation training on improving upper limb motor functions in patients with stroke; 2) To investigate whether stroke patients receiving closed-loop training exhibit higher activation levels in the mirror neurons, measured by event-related desynchronization (ERD), compared to those receiving open-loop training.
Hypothesis to be tested: The closed-loop training is more effective than open-loop training in improving upper limb motor outcomes, and there is an increase in the mirror neurons activity in those receiving closed-loop training.
Design and subjects: A randomized controlled trial with 44 participants with stroke.
Study instruments: Functional near-infrared spectroscopy (fNIRS)-based BCI and electroencephalography (EEG).
Interventions: In the BCI training, participants will engage in kinesthetic motor imagery. When the M1 activation level recorded by fNIRS surpasses a predefined threshold, participants will receive visual feedback to guide them to imitate the movement. However, for participants in the sham BCI group, the visual feedback will be given constantly. Both types of training consist of ten sessions.
Main outcome measures: Upper limb motor tests and the activity of mirror neurons measured by sensorimotor ERD using EEG.
Data analysis: Analysis of variance and correlation. Expected results: The closed-loop BCI-driven observational imitation training is more effective than sham BCI open-loop training on enhancing hemiplegic upper limb functions and the activation of the mirror neurons in patients after stroke.
- Conditions
- Stroke
- Being tested
- Brain-computer interface, Sham brain-computer interface
- Keywords
- Stroke, Brain-computer interface
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-computer interfaceDevice
Patients will perform kinesthetic motor imagery of the affected upper extremity in response to auditory cues from the BCI system. The averaged oxygenated hemoglobin (HbO) level, extracted from optimal channels identified during the localizer session, will serve as signal intensity. This intensity, quantified as percent signal change relative to baseline, will trigger neurofeedback when reaching a predefined threshold. Visual feedback, delivered via the digital mirror therapy system, will guide patients to perform observational imitation tasks using bilateral upper extremities. Each session will include 5-6 movements tailored to the patient's functional performance. After observational imitation training, patients will practice functional adaptation tasks in a virtual environment, where they apply learned movements to functional activities. Sessions will last approximately 75 minutes.
Sham brain-computer interfaceDevice
In the sham group, patients will wear a similar headset equipment as those in the BCI group. However, the visual feedback provided through the digital mirror therapy system will not be based on their own brain activity. Instead, it will be derived from the brain activity of a participant in the BCI group using the simulation mode of Turbo-Satori. Patients in the sham group will receive constant visual feedback, with a fixed duration of 60 seconds for motor imagery, regardless of their actual brain signals. Like the BCI group, patients will be instructed to use kinesthetic motor imagery and imitate the movement when receiving visual feedback, and practice functional adaptation tasks after observational imitation training. The sham training will also last for around 75 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| BCI neurofeedback training | Experimental | Patients will perform kinesthetic motor imagery of the affected upper extremity in response to auditory cues from the BCI system. The averaged oxygenated hemoglobin (HbO) level, extracted from optimal channels identified during the localizer session, will serve as signal intensity. This intensity, quantified as percent signal change relative to baseline, will trigger neurofeedback when reaching a predefined threshold. Visual feedback, delivered via the digital mirror therapy system, will guide patients to perform observational imitation tasks using bilateral upper extremities. Each session will include 5-6 movements tailored to the patient's functional performance. After observational imitation training, patients will practice functional adaptation tasks in a virtual environment, where they apply learned movements to functional activities. Sessions will last approximately 75 minutes. Receives: Device: Brain-computer interface |
| Sham BCI neurofeedback training | Sham comparator | In the sham group, patients will wear a similar headset equipment as those in the BCI group. However, the visual feedback provided through the digital mirror therapy system will not be based on their own brain activity. Instead, it will be derived from the brain activity of a participant in the BCI group using the simulation mode of Turbo-Satori. Patients in the sham group will receive constant visual feedback, with a fixed duration of 60 seconds for motor imagery, regardless of their actual brain signals. Like the BCI group, patients will be instructed to use kinesthetic motor imagery and imitate the movement when receiving visual feedback, and practice functional adaptation tasks after observational imitation training. The sham training will also last for around 75 minutes per session. Receives: Device: Sham brain-computer interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE)
The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE) evaluates upper limb motor impairment post-stroke. It assesses the movement, coordination, and reflex actions of the hemiplegic upper limb. The total scores are 66.
Measured: Baseline
The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE)
The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE) evaluates upper limb motor impairment post-stroke. It assesses the movement, coordination, and reflex actions of the hemiplegic upper limb. The total scores are 66.
Measured: At 2 weeks
The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE)
The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE) evaluates upper limb motor impairment post-stroke. It assesses the movement, coordination, and reflex actions of the hemiplegic upper limb. The total scores are 66.
Measured: At one-month
Secondary outcomes (3)
The Action Research Arm Test (ARAT)
The Action Research Arm Test (ARAT) is an assessment for upper limb functional activities post-stroke, with four subscales to evaluate grasp, grip, pinch, and gross movement, with total scores of 57.
Measured: Baseline
The Action Research Arm Test (ARAT)
The Action Research Arm Test (ARAT) is an assessment for upper limb functional activities post-stroke, with four subscales to evaluate grasp, grip, pinch, and gross movement, with total scores of 57.
Measured: At 2 weeks
The Action Research Arm Test (ARAT)
The Action Research Arm Test (ARAT) is an assessment for upper limb functional activities post-stroke, with four subscales to evaluate grasp, grip, pinch, and gross movement, with total scores of 57.
Measured: At one-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start12 Dec 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- RWTH Aachen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503484
- Sponsor's protocol ID
- HSEARS20231203001
- Status last verified
- Dec 2024
- First submitted
- 10 Jul 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang JJ, Lin R, Zeng RR, Tang M, Chan SSY, Zhang BB, Sun R, Kranz GS, Lau SCL, Luhrs M, Fong KNK, Mathiak K, Mehler DMA, Lau GKK. Using a functional near-infrared spectroscopy-guided brain-computer interface to facilitate observational imitation after stroke. Ann Phys Rehabil Med. 2026 Jun 25;69(6):102149. doi: 10.1016/j.rehab.2026.102149. Online ahead of print.
PubMed 42349111
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing a Brain-Computer Interface for Observational Imitation Training to Enhance Upper Limb Motor Recovery Post-Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06503484
- Acronym / sponsor ID
- HSEARS20231203001
- Conditions
- Stroke
- Keywords
- Stroke, Brain-computer interface
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- RWTH Aachen University
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Jul 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.
Objectives: 1) To compare the effects of closed-loop brain-computer interface (BCI) driven observational imitation training versus sham BCI open-loop observational imitation training on improving upper limb motor functions in patients with stroke; 2) To investigate whether stroke patients receiving closed-loop training exhibit higher activation levels in the mirror neurons, measured by event-related desynchronization (ERD), compared to those receiving open-loop training.
Hypothesis to be tested: The closed-loop training is more effective than open-loop training in improving upper limb motor outcomes, and there is an increase in the mirror neurons activity in those receiving closed-loop training.
Design and subjects: A randomized controlled trial with 44 participants with stroke.
Study instruments: Functional near-infrared spectroscopy (fNIRS)-based BCI and electroencephalography (EEG).
Interventions: In the BCI training, participants will engage in kinesthetic motor imagery. When the M1 activation level recorded by fNIRS surpasses a predefined threshold, participants will receive visual feedback to guide them to imitate the movement. However, for participants in the sham BCI group, the visual feedback will be given will be given constantly. Both types of training consist of ten sessions.
Main outcome measures: Upper limb motor tests and the activity of mirror neurons measured by sensorimotor ERD using EEG.
Data analysis: Analysis of variance and correlation. Expected results: The closed-loop BCI-driven observational imitation training is more effective than sham BCI open-loop training on enhancing hemiplegic upper limb functions and the activation of the mirror neurons in patients after stroke.
Detailed description
Objectives: 1) To compare the effects of closed-loop brain-computer interface (BCI) driven observational imitation training versus sham BCI open-loop observational imitation training on improving upper limb motor functions in patients with stroke; 2) To investigate whether stroke patients receiving closed-loop training exhibit higher activation levels in the mirror neurons, measured by event-related desynchronization (ERD), compared to those receiving open-loop training.
Hypothesis to be tested: The closed-loop training is more effective than open-loop training in improving upper limb motor outcomes, and there is an increase in the mirror neurons activity in those receiving closed-loop training.
Design and subjects: A randomized controlled trial with 44 participants with stroke.
Study instruments: Functional near-infrared spectroscopy (fNIRS)-based BCI and electroencephalography (EEG).
Interventions: In the BCI training, participants will engage in kinesthetic motor imagery. When the M1 activation level recorded by fNIRS surpasses a predefined threshold, participants will receive visual feedback to guide them to imitate the movement. However, for participants in the sham BCI group, the visual feedback will be given constantly. Both types of training consist of ten sessions.
Main outcome measures: Upper limb motor tests and the activity of mirror neurons measured by sensorimotor ERD using EEG.
Data analysis: Analysis of variance and correlation. Expected results: The closed-loop BCI-driven observational imitation training is more effective than sham BCI open-loop training on enhancing hemiplegic upper limb functions and the activation of the mirror neurons in patients after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCI neurofeedback training | Experimental | Device: Brain-computer interfacePatients will perform kinesthetic motor imagery of the affected upper extremity in response to auditory cues from the BCI system. The averaged oxygenated hemoglobin (HbO) level, extracted from optimal channels identified during the localizer session, will serve as signal intensity. This intensity, quantified as percent signal change relative to baseline, will trigger neurofeedback when reaching a predefined threshold. Visual feedback, delivered via the digital mirror therapy system, will guide patients to perform observational imitation tasks using bilateral upper extremities. Each session will include 5-6 movements tailored to the patient's functional performance. After observational imitation training, patients will practice functional adaptation tasks in a virtual environment, where they apply learned movements to functional activities. Sessions will last approximately 75 minutes. |
| Sham BCI neurofeedback training | Sham comparator | Device: Sham brain-computer interfaceIn the sham group, patients will wear a similar headset equipment as those in the BCI group. However, the visual feedback provided through the digital mirror therapy system will not be based on their own brain activity. Instead, it will be derived from the brain activity of a participant in the BCI group using the simulation mode of Turbo-Satori. Patients in the sham group will receive constant visual feedback, with a fixed duration of 60 seconds for motor imagery, regardless of their actual brain signals. Like the BCI group, patients will be instructed to use kinesthetic motor imagery and imitate the movement when receiving visual feedback, and practice functional adaptation tasks after observational imitation training. The sham training will also last for around 75 minutes per session. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- unilateral upper extremity motor deficits caused by ischemic stroke, confirmed by medical documents such as discharge summary and/or neuroimaging examinations.
- chronic phase of stroke, i.e., time after stroke onset more than six months.
- aged between 18 and 75 years old.
- with mildly-to-moderately impaired upper limb functional activity that is stratified according to the levels 3-7 in the Functional Test for the Hemiplegic Upper Extremity.
- able to give informed written consent to participate in the study.
Key exclusion criteria (5 listed)
- previous diagnosis of any neurological disease excluding ischemic stroke.
- presence of any sign of cognitive problems (The Montreal cognitive assessment Hong Kong version<22/30).
- Severe spasticity measured by the Modified Ashworth Scale score>2 in the hand, wrist or elbow extensor muscle in the hemiparetic upper extremity.
- with other notable impairments of the upper limb not caused by stroke (e.g., bone fracture in the past year, congenital deformity, or other impairments).
- current participation in any other treatment programme or clinical study involving exercise, non-invasive brain stimulation, or BCI/neurofeedback.
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 |
|---|---|---|
| Brain-computer interfacePatients will perform kinesthetic motor imagery of the affected upper extremity in response to auditory cues from the BCI system. The averaged oxygenated hemoglobin (HbO) level, extracted from optimal channels identified during the localizer session, will serve as signal intensity. This intensity, quantified as percent signal change relative to baseline, will trigger neurofeedback when reaching a predefined threshold. Visual feedback, delivered via the digital mirror therapy system, will guide patients to perform observational imitation tasks using bilateral upper extremities. Each session will include 5-6 movements tailored to the patient's functional performance. After observational imitation training, patients will practice functional adaptation tasks in a virtual environment, where they apply learned movements to functional activities. Sessions will last approximately 75 minutes. | Device | BCI neurofeedback training |
| Sham brain-computer interfaceIn the sham group, patients will wear a similar headset equipment as those in the BCI group. However, the visual feedback provided through the digital mirror therapy system will not be based on their own brain activity. Instead, it will be derived from the brain activity of a participant in the BCI group using the simulation mode of Turbo-Satori. Patients in the sham group will receive constant visual feedback, with a fixed duration of 60 seconds for motor imagery, regardless of their actual brain signals. Like the BCI group, patients will be instructed to use kinesthetic motor imagery and imitate the movement when receiving visual feedback, and practice functional adaptation tasks after observational imitation training. The sham training will also last for around 75 minutes per session. | Device | Sham BCI neurofeedback training |
Primary outcome
The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE)
Time frame: Baseline
The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE) evaluates upper limb motor impairment post-stroke. It assesses the movement, coordination, and reflex actions of the hemiplegic upper limb. The total scores are 66.
The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE)
Time frame: At 2 weeks
The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE) evaluates upper limb motor impairment post-stroke. It assesses the movement, coordination, and reflex actions of the hemiplegic upper limb. The total scores are 66.
The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE)
Time frame: At one-month
The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE) evaluates upper limb motor impairment post-stroke. It assesses the movement, coordination, and reflex actions of the hemiplegic upper limb. The total scores are 66.
3 secondary outcomes
The Action Research Arm Test (ARAT)
Time frame: Baseline
The Action Research Arm Test (ARAT)
Time frame: At 2 weeks
The Action Research Arm Test (ARAT)
Time frame: At one-month
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 22 Aug 2025.
- Derived from this study: PubMed 42349111Zhang JJ, Lin R, Zeng RR, Tang M, Chan SSY, Zhang BB, Sun R, Kranz GS, Lau SCL, Luhrs M, Fong KNK, Mathiak K, Mehler DMA, Lau GKK. Using a functional near-infrared spectroscopy-guided brain-computer interface to facilitate observational imitation after stroke. Ann Phys Rehabil Med. 2026 Jun 25;69(6):102149. doi: 10.1016/j.rehab.2026.102149. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain-computer interface in people with Stroke, run by The Hong Kong Polytechnic University 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 6 inclusion and 5 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 22 Aug 2025. 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 Jack Jiaqi Zhang, PhD (27666696 ext. 6696, jack-jiaqi.zhang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE) (time frame: Baseline). 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?
On the ClinicalTrials.gov record for NCT06503484, which also lists 1 linked publication.
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 22 Aug 2025.