StrokeNCT05778448

BCI for Hemiparetic Upper Extremities in Patients Due to Stroke

A study testing Brain Computer Interface/ Functional Electrical Stimulation/ Virtual Reality in people with Stroke and Brain Computer Interface, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Non-invasive brain-computer interface (BCI) technology is one of the new training approaches to achieve motor restoration through a closed-loop system from brain activity through event-related desynchronization (ERD) after motor imagery (MI) or movement attempt to peripheral feedback triggered by an external hepatic… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke, Brain Computer Interface
What is being tested?: Brain Computer Interface/ Functional Electrical Stimulation/ Virtual Reality
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteHong Kong
Study dates: 11 Aug 2021to 31 Jul 2023
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Have a diagnosis of ischemic or hemorrhagic stroke to unilateral hemisphere, confirmed by neuroimaging examinations, i.e., brain CT or MRI;
Chronic phase of stroke, i.e., time after stroke onset more than 6 months;
≥ 18 years old;
With severe to moderate levels of hemiparetic upper limb impairment due to stroke, i.e., from levels 1 to 5 in the Functional Test for the Hemiplegic Upper Extremity (FTHUE)
Able to give informed written consent to participate in the study.

Who cannot join

Previous diagnosis of any neurological disease excluding stroke;
Presence of any sign of cognitive problems (Abbreviated Mental Test < 6)
Modified Ashworth score > 2 in wrist extensor muscle in the hemiparetic upper extremity after stroke (Bohannon and Smith, 1987) or with severe pain that hinders upper extremity movement
With other notable impairments of the upper extremity not caused by stroke (e.g., fracture, Rheumatoid Arthritis, or congenital deformity, etc.)

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

The Hong Polytechnic University, Department of Rehabilitation Sciences
Hong Kong, Hong Kong, Hung Hom

Other trials in Hong Kong

About this study

Official title: Brain-computer Interface (BCI) Based Closed-loop Training for Hemiparetic Upper Extremities in Patients Due to Stroke: A Randomized Controlled Study

This study adopts a closed-loop BCI system involving ERD induced by MI. Functional electrical stimulation (FES) and virtual reality (VR) are simultaneously delivered as feedback. The aim is to investigate the efficacy of closed-loop BCI training combined with FES and VR on the recovery of the hemiparetic upper extremity of individuals with chronic stroke.

Chronic stroke survivors are being recruited and randomly allocated into 3 groups: (1) BCI-FES-VR - participants look at an external screen displaying the VR avatar participant's arms while performing wrist dorsiflexion MI in random order (left or right). The BCI system detects the ERD of the motor area corresponding to correct MI. Then, visual feedback with the VR and motor-tactile feedback with the discharge of the FES is delivered; (2) BCI-FES - same procedure as group 1, but the difference is that the participant's hands replace the VR system; (3) BCI-VR - same procedure as group 1, but the FES is removed. Each session requires 240 MI trials with a training duration of 10 sessions in a 3-week interval.

Motor and MI assessments are being conducted at post-assessment and at a 3-week follow-up.

The findings of this study will provide significant new information regarding neurophysiological motor relearning mechanisms, which could inform the development and evaluation of BCI-based treatment for individuals with stroke and impact the field of translational neuroscience.

Conditions: Stroke, Brain Computer Interface
Being tested: Brain Computer Interface/ Functional Electrical Stimulation/ Virtual Reality
Keywords: Stroke, Brain Computer Interface, Neurorehabilitation, Event Related Desynchronization
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 Interface/ Functional Electrical Stimulation/ Virtual RealityDevice
A BCI system involves 3 main components - (1) brain activity collection, (2) external devices triggered by specific features of brain activity, and (3) a processor which decodes the brain activity signal and then translates it into computerized commands to control external devices such as virtual games and functional electrical stimulation (FES).

Study groups in NCT05778448
Study group	Role	What they receive
BCI-FES-VR	Experimental	Participants look at an external screen displaying the VR avatar participant's arms while performing wrist dorsiflexion MI in random order (left or right). The BCI system detects the ERD of the motor area corresponding to correct MI. Then, visual feedback with the VR and motor-tactile feedback with the discharge of the FES is delivered. Each session requires 240 MI trials with a training duration of 10 sessions in a 3-week interval. Receives: Device: Brain Computer Interface/ Functional Electrical Stimulation/ Virtual Reality
BCI-FES	Active comparator	Same procedure as arm 1 (BCI-FES-VR), but the difference is that the participant's hands replace the VR system. Each session requires 240 MI trials with a training duration of 10 sessions in a 3-week interval. Receives: Device: Brain Computer Interface/ Functional Electrical Stimulation/ Virtual Reality
BCI-VR	Active comparator	Same procedure as arm 1 (BCI-FES-VR), but the FES is removed. Each session requires 240 MI trials with a training duration of 10 sessions in a 3-week interval. Each session requires 240 MI trials with a training duration of 10 sessions in a 3-week interval. Receives: Device: Brain Computer Interface/ Functional Electrical Stimulation/ Virtual Reality

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
FMA-UE is a clinical assessment for upper limb motor impairment after stroke. It includes 33 items assessing the movement, coordination, and reflex actions of the shoulder, elbow, forearm, and wrist, and the hand joints of the hemiparetic arm. Each item consists of a 3-point ordinal scale (0, 1 and 2), with a total score of 66. The higher the score, the better the performance.
Measured: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
Change from Baseline Action Research Arm Test (ARAT)
The ARAT is a clinical assessment for upper limb functional activities for patients with stroke. The ARAT assesses proximal and distal components of upper limb function. It consists of four subscales: grasp, grip, pinch, and gross movement. It has 19 movement tasks, each graded using a four-point ordinal scale (total scores range from 0 to 57)
Measured: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)

Secondary outcomes (4)

Revised Purdue Spatial Visualization Test (Revised PSVT:R)
This test consists of 30 questions designed to see how well a participant can visualize the rotation of three-dimensional objects.
objects. Each correct answer scores 1 point. The total score is 30 points. The higher the score, the better the performance.
Measured: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
The aim of this questionnaire is to determine the extent to which individuals are able to visualize and feel imagined movements. All movements are assessed from a sitting position. The questionnaire includes a visual imagery scale and a kinesthetic imagery scale. The long version (KVIQ-20) comprises 20 items (10 movements for each scale). The rating scale is a 5-point ordinal scale, the clarity of the visual image ( Items V1 to V10) or the intensity of the sensations associated with the imagined movement (Items K1 to K10). The higher the score, the better the outcome. The highest score is 50.
Measured: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
Hand grip strength test
It is a measure of muscular strength or the maximum force/tension generated by the participant's forearm muscles.
Measured: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
Motor Activity Log (MAL)
It is a subjective measure of an individual's real life functional upper limb performance and consists of two scales: the amount of use and quality of movement. The MAL adopts a 6-point ordinal scale from 0 to 5. The higher the score, the better the outcome.
Measured: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Aug 202131 Jul 2023

First posted21 Mar 2023
Study start11 Aug 2021
Primary completion31 Jul 2023
Study completion31 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05778448
Sponsor's protocol ID: BCI_KennethFong_PabloCruz
Status last verified: Jun 2026
First submitted: 31 Jan 2023
Last updated: 8 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bai Z, Fong KNK, Zhang JJ, Chan J, Ting KH. Immediate and long-term effects of BCI-based rehabilitation of the upper extremity after stroke: a systematic review and meta-analysis. J Neuroeng Rehabil. 2020 Apr 25;17(1):57. doi: 10.1186/s12984-020-00686-2.
PubMed 32334608
Sitaram R, Ros T, Stoeckel L, Haller S, Scharnowski F, Lewis-Peacock J, Weiskopf N, Blefari ML, Rana M, Oblak E, Birbaumer N, Sulzer J. Closed-loop brain training: the science of neurofeedback. Nat Rev Neurosci. 2017 Feb;18(2):86-100. doi: 10.1038/nrn.2016.164. Epub 2016 Dec 22.
PubMed 28003656
Cruz Gonzalez, P., Fong, K. N., & Brown, T. (2022). Closed-Loop Brain-Computer Interface Training for Hemiparetic Upper Extremities in Patients with Chronic Stroke: A randomized control study [Abstract]. Neurorehabilitation and Neural Repair. Poster presentation at the 12th World Congress for Neurorehabilitation, December 2022, Vienna, Austria.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brain-computer Interface (BCI) Based Closed-loop Training for Hemiparetic Upper Extremities in Patients Due to Stroke: A Randomized Controlled Study
ClinicalTrials.gov ID: NCT05778448
Acronym / sponsor ID: BCI_KennethFong_PabloCruz
Conditions: Stroke, Brain Computer Interface
Keywords: Stroke, Brain Computer Interface, Neurorehabilitation, Event Related Desynchronization
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: The Hong Kong Polytechnic UniversityUniversity, hospital or other
Study start: 11 Aug 2021 (actual)
Primary completion: 31 Jul 2023 (actual)
Study completion: 31 Jul 2023 (actual)
First posted: 21 Mar 2023 (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.

Motor and MI assessments are being conducted at post-assessment and at a 3-week follow-up.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
BCI-FES-VR	Experimental	Device: Brain Computer Interface/ Functional Electrical Stimulation/ Virtual RealityParticipants look at an external screen displaying the VR avatar participant's arms while performing wrist dorsiflexion MI in random order (left or right). The BCI system detects the ERD of the motor area corresponding to correct MI. Then, visual feedback with the VR and motor-tactile feedback with the discharge of the FES is delivered. Each session requires 240 MI trials with a training duration of 10 sessions in a 3-week interval.
BCI-FES	Active comparator	Device: Brain Computer Interface/ Functional Electrical Stimulation/ Virtual RealitySame procedure as arm 1 (BCI-FES-VR), but the difference is that the participant's hands replace the VR system. Each session requires 240 MI trials with a training duration of 10 sessions in a 3-week interval.
BCI-VR	Active comparator	Device: Brain Computer Interface/ Functional Electrical Stimulation/ Virtual RealitySame procedure as arm 1 (BCI-FES-VR), but the FES is removed. Each session requires 240 MI trials with a training duration of 10 sessions in a 3-week interval. Each session requires 240 MI trials with a training duration of 10 sessions in a 3-week interval.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Have a diagnosis of ischemic or hemorrhagic stroke to unilateral hemisphere, confirmed by neuroimaging examinations, i.e., brain CT or MRI;
Chronic phase of stroke, i.e., time after stroke onset more than 6 months;
≥ 18 years old;
With severe to moderate levels of hemiparetic upper limb impairment due to stroke, i.e., from levels 1 to 5 in the Functional Test for the Hemiplegic Upper Extremity (FTHUE)
Able to give informed written consent to participate in the study.

Key exclusion criteria (4 listed)

Previous diagnosis of any neurological disease excluding stroke;
Presence of any sign of cognitive problems (Abbreviated Mental Test < 6)
Modified Ashworth score > 2 in wrist extensor muscle in the hemiparetic upper extremity after stroke (Bohannon and Smith, 1987) or with severe pain that hinders upper extremity movement
With other notable impairments of the upper extremity not caused by stroke (e.g., fracture, Rheumatoid Arthritis, or congenital deformity, etc.)

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 Interface/ Functional Electrical Stimulation/ Virtual RealityA BCI system involves 3 main components - (1) brain activity collection, (2) external devices triggered by specific features of brain activity, and (3) a processor which decodes the brain activity signal and then translates it into computerized commands to control external devices such as virtual games and functional electrical stimulation (FES).	Device	BCI-FES, BCI-FES-VR, BCI-VR

Primary outcome

Change from Baseline Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Time frame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
FMA-UE is a clinical assessment for upper limb motor impairment after stroke. It includes 33 items assessing the movement, coordination, and reflex actions of the shoulder, elbow, forearm, and wrist, and the hand joints of the hemiparetic arm. Each item consists of a 3-point ordinal scale (0, 1 and 2), with a total score of 66. The higher the score, the better the performance.
Change from Baseline Action Research Arm Test (ARAT)
Time frame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
The ARAT is a clinical assessment for upper limb functional activities for patients with stroke. The ARAT assesses proximal and distal components of upper limb function. It consists of four subscales: grasp, grip, pinch, and gross movement. It has 19 movement tasks, each graded using a four-point ordinal scale (total scores range from 0 to 57)

4 secondary outcomes

Revised Purdue Spatial Visualization Test (Revised PSVT:R)
Time frame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Time frame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
Hand grip strength test
Time frame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
Motor Activity Log (MAL)
Time frame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
Background: PubMed 32334608Bai Z, Fong KNK, Zhang JJ, Chan J, Ting KH. Immediate and long-term effects of BCI-based rehabilitation of the upper extremity after stroke: a systematic review and meta-analysis. J Neuroeng Rehabil. 2020 Apr 25;17(1):57. doi: 10.1186/s12984-020-00686-2.
Background: PubMed 28003656Sitaram R, Ros T, Stoeckel L, Haller S, Scharnowski F, Lewis-Peacock J, Weiskopf N, Blefari ML, Rana M, Oblak E, Birbaumer N, Sulzer J. Closed-loop brain training: the science of neurofeedback. Nat Rev Neurosci. 2017 Feb;18(2):86-100. doi: 10.1038/nrn.2016.164. Epub 2016 Dec 22.
BackgroundCruz Gonzalez, P., Fong, K. N., & Brown, T. (2022). Closed-Loop Brain-Computer Interface Training for Hemiparetic Upper Extremities in Patients with Chronic Stroke: A randomized control study [Abstract]. Neurorehabilitation and Neural Repair. Poster presentation at the 12th World Congress for Neurorehabilitation, December 2022, Vienna, Austria.
Individual participant dataSharing planned: No

Related trials for Stroke

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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 4 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: finished, as of the sponsor's last update on 8 Jun 2026. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Fugl-Meyer Assessment - Upper Extremity (FMA-UE) (time frame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)). The study lists 2 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 NCT05778448, which also lists 3 linked publications.

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 8 Jun 2026.