StrokeNOISySNCT07374276
BCI With Virtual Reality for Stroke Rehabilitation: A Crossover Study
A study testing Motor Imagery-based Brain-Computer Interface coupled with Virtual Reality (MI-BCI-VR) and Motor Imagery-based Brain-Computer Interface (MI-BCI) in people with Stroke, run by Technical University of Lisbon at 1 site in Portugal.
Trial summary
The goal of this clinical trial is to investigate if training sessions of motor imagery associated with brain-computer interface and motor observation through virtual reality (MI-VR-BCI) can help to improve arm and hand recovery after a stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Motor Imagery-based Brain-Computer Interface coupled with Virtual Reality (MI-BCI-VR) and Motor Imagery-based Brain-Computer Interface (MI-BCI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 sitePortugal
- Study dates
- 5 Jan 2026to Mar 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of stroke confirmed by neuroimaging, with resulting upper limb hemiparesis.
- Time since stroke between 6 and 24 months at the time of selection.
- Sufficient cognitive ability to understand and follow the intervention procedures.
- Spasticity score <3 on the Modified Ashworth Scale in upper limb muscle groups.
- Adults aged 18 to 80 years.
- Ability to remain seated for approximately 2 hours.
- Motivation to participate and capacity to provide informed consent.
- Undergoing conventional rehabilitation therapy during the study period.
Who cannot join
- Severe communication difficulties preventing comprehension or execution of instructions.
- Skin lesions, allergies, or metal implants in the cephalic region, or history of craniectomy, that hinder electrode placement or interfere with EEG signal acquisition.
- Concomitant neurological or musculoskeletal conditions affecting upper limb motor function.
- Other neurological, musculoskeletal, or psychiatric conditions that may compromise participation or study outcomes (e.g., major depression, severe visual impairment, photosensitive epilepsy, frequent vertigo or dizziness).
- Upper limb impairment due to a previous stroke.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Centro de Medicina de Reabilitação de Alcoitão
Alcabideche, Lisbon District, 2649-506
About this study
Official title: Brain-Computer Interface (BCI) With Virtual Reality (VR) in Upper Limb Rehabilitation After Stroke: A Randomized Crossover Clinical Trial
The goal of this clinical trial is to investigate if training sessions of motor imagery associated with brain-computer interface and motor observation through virtual reality (MI-VR-BCI) can help to improve arm and hand recovery after a stroke. The main questions to answer are:
- Can adding MI-BCI-VR sessions improve upper limb movement?
- Can it help stroke survivors perform daily activities more easily?
- Does this type of training improve brain activity and connections related to movement?
Read more
Researchers will compare this type of intervention with motor imagery associated with a standard brain-computer interface intervention (MI-BCI) to see if there are added effects to upper limb function, activity and brain connections.
Participants will :
- Perform two intervention periods in a random order: one with MI-VR-BCI training sessions and other with MI-BCI training sessions. Each period will involve 3 weekly sessions of training, during 6 weeks, with the intervention periods being separated by 3 weeks.
- Complete four assessment sessions: one at the beginning and another at the end of each intervention period.
Read the detailed description
Stroke is a leading cause of long-term disability worldwide, often resulting in upper limb (UL) impairment. Approximately 70% of stroke survivors experience UL dysfunction, with a significant portion continuing to show deficits into the chronic phase. This impacts independence and quality of life, highlighting the need for effective rehabilitation strategies.
Brain-Computer Interface (BCI) interventions have shown promise in improving UL function by enabling patients to modulate brain activity through neurofeedback in a closed-loop system. When combined with multisensory feedback (visual, auditory, and somatosensory) BCIs may promote neuroplasticity and motor recovery. The use of Motor Imagery (MI) and embodied Virtual Reality (VR) may further enhance motor learning by reinforcing motor patterns and creating meaningful, immersive rehabilitation experiences.
Despite encouraging evidence, the clinical and neurophysiological benefits of combining BCI with VR and MI remain underexplored, particularly when associated with longer intervention periods, the impact in activities of daily living and the influence of patient-specific traits such as motor, cognitive, or behavioral dimensions. In light of these considerations, the primary objectives of this study are:
- To assess the preliminary effects of applying a motor imagery based Brain-Computer Interface with Virtual Reality (MI-BCI-VR) paradigm on upper limb function and activity in individuals with stroke.
- To evaluate the neurophysiological effects of this intervention on brain activity and its relationship with clinical measures of upper limb function.
The secondary objectives of the study are:
- To explore the influence of individual characteristics on clinical outcomes and neurophysiological changes observed.
- To examine the specific contribution of embodied Virtual Reality associated with BCI in upper limb rehabilitation after stroke.
- To understand participant's experience with the different intervention paradigms, including acceptability and usability, and to inform the technology development process.
- Conditions
- Stroke
- Being tested
- Motor Imagery-based Brain-Computer Interface coupled with Virtual Reality (MI-BCI-VR), Motor Imagery-based Brain-Computer Interface (MI-BCI)
- Keywords
- Stroke, Brain-Computer Interface, Virtual Reality, Motor Imagery, Upper Extremity, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Imagery-based Brain-Computer Interface coupled with Virtual Reality (MI-BCI-VR)Device
The training paradigm will involve motor imagery coupled with EEG-based BCI control and immersive virtual reality (VR) feedback. VR feedback will consist of NeuRow, a first-person perspective training paradigm that allows multimodal visual, auditory and haptic feedback through the use of immersive virtual reality headset and haptic controllers. Sessions will have a frequency of 3 times per week, during 6 weeks.
Motor Imagery-based Brain-Computer Interface (MI-BCI)Device
The training paradigm will involve motor imagery combined with EEG-based BCI control using a cue-based visual paradigm. Sessions will be conducted three times per week over a period of six weeks.
| Study group | Role | What they receive |
|---|---|---|
| MI-VR-BCI Training | Experimental | Participants will perform motor imagery-based brain-computer interface training combined with immersive virtual reality and multimodal feedback (visual, auditory, and haptic). Receives: Device: Motor Imagery-based Brain-Computer Interface coupled with Virtual Reality (MI-BCI-VR) |
| MI-BCI | Active comparator | Participants will perform motor imagery-based brain-computer interface (MI-BCI) training based on a cue-based protocol. Receives: Device: Motor Imagery-based Brain-Computer Interface (MI-BCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Upper Limb Motor Function (Fugl-Meyer Assessment - Upper Extremity)
Within-subject difference in the change in upper limb motor function, as assessed by the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), between the two intervention conditions (MI-BCI-VR vs. MI-BCI). FMA-UE scores range from 0 to 66, with higher scores indicating better motor function and less impairment.
Measured: Baseline and end of each 6-week intervention period (up to 15 weeks total, including washout).
Change in Upper Limb Activity (Action Research Arm Test - ARAT)
Within-subject difference in the change in upper limb activity, as assessed by the Action Research Arm Test (ARAT), between the two intervention conditions (MI-BCI-VR vs. MI-BCI). The ARAT is a standardized measure that evaluates upper limb functioning through tasks involving grasp, grip, pinch, and gross movement. Scores range from 0 to 57, with higher scores indicating better functional ability. This outcome assesses the impact of the intervention on functional use of the affected arm in daily activities.
Measured: Baseline and end of each 6-week intervention period (up to 15 weeks total, including washout).
Change in EEG Event-Related Desynchronization/Synchronization (ERD/ERS)
Changes in event-related desynchronization and synchronization (ERD/ERS) during motor imagery tasks, derived from EEG recordings to assess intervention-related modulation of sensorimotor cortical activity.
Measured: During each intervention session across both 6-week intervention periods (up to 15 weeks total, including washout).
Change in EEG Hemispheric Lateralization Index
Changes in EEG-derived hemispheric lateralization indices during motor imagery tasks, used to evaluate intervention-related reorganization of cortical motor networks.
Measured: During each intervention session across both 6-week intervention periods (up to 15 weeks total, including washout).
Change in EEG Connectivity Measures
Exploratory changes in EEG-based functional connectivity metrics between motor-related cortical regions during motor imagery tasks.
Measured: During each intervention session across both 6-week intervention periods (up to 15 weeks total, including washout).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start5 Jan 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (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.
- 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
- Crossover
- Model description
- Each participant will complete two intervention periods, corresponding to two different intervention types (MI-VR-BCI or MI-BCI), administered in a randomized order. A 3-week washout period will separate the two intervention periods. Pre- and post-intervention assessments will be conducted for each period, resulting in a total of four assessments per participant.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Lisbon
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Medicina de Reabilitação de Alcoitão
- Responsible party
- Principal investigator, Athanasios Vourvopoulos, Technical University of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374276
- Sponsor's protocol ID
- 1801P.01287
- Other IDs
- 10.54499/2022.02283.PTDC
- Acronym
- NOISyS
- Status last verified
- Jan 2026
- First submitted
- 9 Dec 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain-Computer Interface (BCI) With Virtual Reality (VR) in Upper Limb Rehabilitation After Stroke: A Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT07374276
- Acronym / sponsor ID
- NOISyS / 1801P.01287
- Conditions
- Stroke
- Keywords
- Stroke, Brain-Computer Interface, Virtual Reality, Motor Imagery, Upper Extremity, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Technical University of LisbonUniversity, hospital or other
- Collaborators
- Centro de Medicina de Reabilitação de Alcoitão
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Jan 2026 (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.
The goal of this clinical trial is to investigate if training sessions of motor imagery associated with brain-computer interface and motor observation through virtual reality (MI-VR-BCI) can help to improve arm and hand recovery after a stroke. The main questions to answer are:
- Can adding MI-BCI-VR sessions improve upper limb movement?
- Can it help stroke survivors perform daily activities more easily?
- Does this type of training improve brain activity and connections related to movement?
Researchers will compare this type of intervention with motor imagery associated with a standard brain-computer interface intervention (MI-BCI) to see if there are added effects to upper limb function, activity and brain connections.
Participants will :
- Perform two intervention periods in a random order: one with MI-VR-BCI training sessions and other with MI-BCI training sessions. Each period will involve 3 weekly sessions of training, during 6 weeks, with the intervention periods being separated by 3 weeks.
- Complete four assessment sessions: one at the beginning and another at the end of each intervention period.
Detailed description
Stroke is a leading cause of long-term disability worldwide, often resulting in upper limb (UL) impairment. Approximately 70% of stroke survivors experience UL dysfunction, with a significant portion continuing to show deficits into the chronic phase. This impacts independence and quality of life, highlighting the need for effective rehabilitation strategies.
Brain-Computer Interface (BCI) interventions have shown promise in improving UL function by enabling patients to modulate brain activity through neurofeedback in a closed-loop system. When combined with multisensory feedback (visual, auditory, and somatosensory) BCIs may promote neuroplasticity and motor recovery. The use of Motor Imagery (MI) and embodied Virtual Reality (VR) may further enhance motor learning by reinforcing motor patterns and creating meaningful, immersive rehabilitation experiences.
Despite encouraging evidence, the clinical and neurophysiological benefits of combining BCI with VR and MI remain underexplored, particularly when associated with longer intervention periods, the impact in activities of daily living and the influence of patient-specific traits such as motor, cognitive, or behavioral dimensions. In light of these considerations, the primary objectives of this study are:
- To assess the preliminary effects of applying a motor imagery based Brain-Computer Interface with Virtual Reality (MI-BCI-VR) paradigm on upper limb function and activity in individuals with stroke.
- To evaluate the neurophysiological effects of this intervention on brain activity and its relationship with clinical measures of upper limb function.
The secondary objectives of the study are:
- To explore the influence of individual characteristics on clinical outcomes and neurophysiological changes observed.
- To examine the specific contribution of embodied Virtual Reality associated with BCI in upper limb rehabilitation after stroke.
- To understand participant's experience with the different intervention paradigms, including acceptability and usability, and to inform the technology development process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant will complete two intervention periods, corresponding to two different intervention types (MI-VR-BCI or MI-BCI), administered in a randomized order. A 3-week washout period will separate the two intervention periods. Pre- and post-intervention assessments will be conducted for each period, resulting in a total of four assessments per participant.
| Arm | Type | Receives |
|---|---|---|
| MI-VR-BCI Training | Experimental | Device: Motor Imagery-based Brain-Computer Interface coupled with Virtual Reality (MI-BCI-VR)Participants will perform motor imagery-based brain-computer interface training combined with immersive virtual reality and multimodal feedback (visual, auditory, and haptic). |
| MI-BCI | Active comparator | Device: Motor Imagery-based Brain-Computer Interface (MI-BCI)Participants will perform motor imagery-based brain-computer interface (MI-BCI) training based on a cue-based protocol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of stroke confirmed by neuroimaging, with resulting upper limb hemiparesis.
- Time since stroke between 6 and 24 months at the time of selection.
- Sufficient cognitive ability to understand and follow the intervention procedures.
- Spasticity score <3 on the Modified Ashworth Scale in upper limb muscle groups.
- Adults aged 18 to 80 years.
Key exclusion criteria (5 listed)
- Severe communication difficulties preventing comprehension or execution of instructions.
- Skin lesions, allergies, or metal implants in the cephalic region, or history of craniectomy, that hinder electrode placement or interfere with EEG signal acquisition.
- Concomitant neurological or musculoskeletal conditions affecting upper limb motor function.
- Other neurological, musculoskeletal, or psychiatric conditions that may compromise participation or study outcomes (e.g., major depression, severe visual impairment, photosensitive epilepsy, frequent vertigo or dizziness).
- Upper limb impairment due to a previous stroke.
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 |
|---|---|---|
| Motor Imagery-based Brain-Computer Interface coupled with Virtual Reality (MI-BCI-VR)The training paradigm will involve motor imagery coupled with EEG-based BCI control and immersive virtual reality (VR) feedback. VR feedback will consist of NeuRow, a first-person perspective training paradigm that allows multimodal visual, auditory and haptic feedback through the use of immersive virtual reality headset and haptic controllers. Sessions will have a frequency of 3 times per week, during 6 weeks. | Device | MI-VR-BCI Training |
| Motor Imagery-based Brain-Computer Interface (MI-BCI)The training paradigm will involve motor imagery combined with EEG-based BCI control using a cue-based visual paradigm. Sessions will be conducted three times per week over a period of six weeks. | Device | MI-BCI |
Primary outcome
Change in Upper Limb Motor Function (Fugl-Meyer Assessment - Upper Extremity)
Time frame: Baseline and end of each 6-week intervention period (up to 15 weeks total, including washout).
Within-subject difference in the change in upper limb motor function, as assessed by the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), between the two intervention conditions (MI-BCI-VR vs. MI-BCI). FMA-UE scores range from 0 to 66, with higher scores indicating better motor function and less impairment.
Change in Upper Limb Activity (Action Research Arm Test - ARAT)
Time frame: Baseline and end of each 6-week intervention period (up to 15 weeks total, including washout).
Within-subject difference in the change in upper limb activity, as assessed by the Action Research Arm Test (ARAT), between the two intervention conditions (MI-BCI-VR vs. MI-BCI). The ARAT is a standardized measure that evaluates upper limb functioning through tasks involving grasp, grip, pinch, and gross movement. Scores range from 0 to 57, with higher scores indicating better functional ability. This outcome assesses the impact of the intervention on functional use of the affected arm in daily activities.
Change in EEG Event-Related Desynchronization/Synchronization (ERD/ERS)
Time frame: During each intervention session across both 6-week intervention periods (up to 15 weeks total, including washout).
Changes in event-related desynchronization and synchronization (ERD/ERS) during motor imagery tasks, derived from EEG recordings to assess intervention-related modulation of sensorimotor cortical activity.
Change in EEG Hemispheric Lateralization Index
Time frame: During each intervention session across both 6-week intervention periods (up to 15 weeks total, including washout).
Changes in EEG-derived hemispheric lateralization indices during motor imagery tasks, used to evaluate intervention-related reorganization of cortical motor networks.
Change in EEG Connectivity Measures
Time frame: During each intervention session across both 6-week intervention periods (up to 15 weeks total, including washout).
Exploratory changes in EEG-based functional connectivity metrics between motor-related cortical regions during motor imagery tasks.
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 21 Sep 2026.
- NOISyS project webpage providing an overview of the project, including objectives, consortium members, and outputs.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the study team.
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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?
A study testing Motor Imagery-based Brain-Computer Interface coupled with Virtual Reality (MI-BCI-VR) and Motor Imagery-based Brain-Computer Interface (MI-BCI) in people with Stroke, run by Technical University of Lisbon at 1 site in Portugal.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 21 Sep 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 Portugal. 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?
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?
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 in Upper Limb Motor Function (Fugl-Meyer Assessment - Upper Extremity) (time frame: Baseline and end of each 6-week intervention period (up to 15 weeks total, including washout).). The study lists 5 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 Sep 2026.