StrokeNCT07525609
Neurofeedback-Guided BCI Motor Imagery for Upper-Limb Recovery in Chronic Stroke
A study testing Motor imagery-based training - Real Neurofeedback in people with Stroke and Upper Limb Rehabilitation, run by CESPU-Escola Superior de Tecnologias da Saúde de Tâmega e Sousa.
Trial summary
Stroke can lead to long-term impairment of upper-limb function, particularly in the chronic phase, where recovery is often limited. Brain-computer interface (BCI) systems combined with motor imagery (MI) are emerging as promising neurorehabilitation approaches. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Upper Limb Rehabilitation
- What is being tested?
- Motor imagery-based training - Real Neurofeedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Jul 2015
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years
- First-ever cortical ischemic stroke affecting the left middle cerebral artery (MCA) territory
- ≥12 months since stroke onset
- Stroke diagnosis confirmed by structural neuroimaging (MRI or CT)
- Lesion localization confirmed based on clinical and radiological criteria
Who cannot join
- Complete hand plegia
- Presence of language or cognitive impairment, as assessed by the Montreal Cognitive Assessment (MoCA)
- Presence of attentional deficits
- Presence of visual impairments that may interfere with task performance
- Diagnosis of depression
- Pre-stroke dependence in activities of daily living
Show all 9Show fewer
- Left-handedness, as assessed by the Edinburgh Handedness Inventory
- Inability to perform motor imagery tasks
- Contraindications to MRI (e.g., metallic implants, implanted electronic devices, or claustrophobia)
About this study
Official title: Neurofeedback-guided Motor Imagery Using a Brain-Computer Interface in Chronic Stroke: a Controlled Pilot Study on Upper-limb Function and Brain Symmetry
Stroke can lead to long-term impairment of upper-limb function, particularly in the chronic phase, where recovery is often limited. Brain-computer interface (BCI) systems combined with motor imagery (MI) are emerging as promising neurorehabilitation approaches. Providing real-time neurofeedback during MI may enhance motor recovery by promoting use-dependent neuroplasticity; however, evidence in individuals with chronic stroke remains limited.
This controlled pilot study aims to evaluate the feasibility and preliminary effects of an EEG-based BCI neurofeedback intervention combined with MI and physiotherapy on upper-limb motor function and brain activation patterns in individuals with chronic stroke. Participants are assigned to either an experimental group receiving MI with real-time EEG-based neurofeedback or a control group receiving MI with sham feedback, alongside a standardized four-week physiotherapy program.
Read more
Motor function is assessed using validated clinical measures, including the Action Research Arm Test, Fugl-Meyer Assessment, Motor Assessment Scale, and grip strength, with changes interpreted according to clinically meaningful thresholds. Neurophysiological changes are explored through EEG-based measures of brain symmetry and task-related functional MRI.
It is expected that participants receiving real neurofeedback will show greater improvements in upper-limb function and more adaptive brain activation patterns compared to those receiving sham feedback. Findings from this study will help determine the feasibility of this approach and inform the design of larger trials to evaluate its effectiveness in chronic stroke rehabilitation.
Read the detailed description
This study follows a double-blind design in which both participants and outcome assessors are unaware of group allocation, minimizing potential sources of bias. The inclusion of a sham feedback condition is intended to control for nonspecific effects related to task engagement, attention, and exposure to the intervention environment.
The neurofeedback protocol is based on real-time modulation of EEG-derived sensorimotor rhythms during motor imagery tasks. In the experimental group, feedback is contingent on participants' brain activity, enabling reinforcement of targeted neural patterns. In the control group, feedback is non-contingent but visually similar, ensuring maintenance of blinding.
To ensure intervention fidelity, the protocol is delivered over a fixed duration with standardized procedures across participants. The integration of the neurofeedback intervention within a structured rehabilitation schedule is designed to minimize variability and support consistency in delivery.
Outcome interpretation incorporates minimal clinically important difference (MCID) thresholds to distinguish clinically meaningful improvements. In addition, the combined use of EEG and task-related functional MRI provides complementary insight into neuroplasticity, capturing both temporal dynamics and spatial patterns of brain reorganization.
Feasibility is further evaluated through indicators such as adherence to the intervention protocol, participant retention, and the practicality of implementing EEG-based neurofeedback in a rehabilitation context. These elements are intended to inform protocol optimization and the design of future randomized controlled trials.
- Conditions
- Stroke, Upper Limb Rehabilitation
- Being tested
- Motor imagery-based training - Real Neurofeedback, Motor imagery-based training - Sham Neurofeedback
- Keywords
- Brain-machine interface, Neuroplasticity, Physical therapy, Stroke Rehabilitation, Upper-limb recovery
- 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 training - Real NeurofeedbackOther
Also called Physiotherapy based on a problem-solving therapeutic model
Participants completed 12 sessions of motor imagery (MI)-based training (30 minutes/session, 3× weekly) using an EEG-based BCI system (Emotiv® EPOC headset, 14 channels). During each session, participants imagined moving their right or left hand to push a virtual ball, guided by directional cues. Real-time neurofeedback of the ball movement was provided contingent on participants' brain activity. Each MI session was followed by a standardized physiotherapy session based on a problem-solving therapeutic model.
Motor imagery-based training - Sham NeurofeedbackOther
Also called Physiotherapy based on a problem-solving therapeutic model
Participants completed 12 sessions of motor imagery (MI)-based training (30 minutes/session, 3× weekly) using an EEG-based BCI system (Emotiv® EPOC headset, 14 channels). Participants completed the same MI-based training and physiotherapy schedule. During MI, they received sham feedback: pre-recorded visual feedback from previous sessions, not contingent on their brain activity. All other procedures, including trial structure, session frequency, and physiotherapy, were identical to the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Motor imagery-based training - Real Neurofeedback | Experimental | Participants perform motor imagery tasks combined with real-time EEG-based brain-computer interface (BCI) neurofeedback alongside a standardized four-week physiotherapy program. Feedback is contingent on participants' brain activity to reinforce sensorimotor activation patterns. Receives: Other: Motor imagery-based training - Real Neurofeedback |
| Motor imagery-based training - Sham Neurofeedback | Sham comparator | Participants perform the same motor imagery tasks with sham (non-contingent) feedback alongside the same physiotherapy program. Feedback is visually similar but not based on actual brain activity, serving as a control for nonspecific effects of training. Receives: Other: Motor imagery-based training - Sham Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroplasticity
Assessed using combined EEG-fMRI measures. EEG was recorded with a 64-channel MRI-compatible system during motor execution (ME) and motor imagery (MI) tasks for both hands, with simultaneous fMRI acquisition. Brain symmetry index (BSI) was computed from mu (8-13 Hz) and beta (14-30 Hz) band activity in ipsilesional (C1, C3, FC1, FC3) and contralesional (C2, C4, FC2, FC4) motor cortical regions. fMRI data were acquired on a 3.0 Tesla scanner and analyzed using standard preprocessing and SPM8 to evaluate functional activation patterns.
Measured: Pre- and post-intervention (4 weeks)
Secondary outcomes (5)
Upper-limb motor function - Action Research Arm Test (ARAT)
Functional assessment of upper-limb dexterity. Scored independently by two blinded raters from video recordings. Score range: 0 to 57. Direction: Higher scores indicate better upper limb function.
Measured: Pre- and post-intervention (4 weeks)
Upper-limb motor function - Fugl-Meyer Assessment - Upper Extremity. (FMA-UE)
Fugl-Meyer Assessment - Upper Extremity. The FMA-UE is a stroke-specific, impairment-based subscale of the Fugl-Meyer Assessment that evaluates motor function of the upper extremity, including reflex activity, voluntary movement within and out of synergy patterns, coordination, and speed. It is widely used to quantify motor recovery following stroke. Score range: 0 to 66. Direction: Higher scores indicate less motor impairment (better upper limb function). Summary description:
Measured: Pre- and post-intervention (4 weeks)
Upper-limb motor function - Motor Assessment Scale (MAS)
Motor Assessment Scale - Upper Limb Items. This subset of the Motor Assessment Scale includes the upper limb-related items (upper arm function, hand movements, and advanced hand activities). Each item is scored from 0 to 6, providing a focused assessment of functional motor performance of the upper limb in individuals post-stroke. Score range: 0 to 18. Direction: Higher scores indicate better upper limb motor function
Measured: Pre- and post-intervention (4 weeks)
Handgrip strength
Measured using a Baseline® Hydraulic Hand Dynamometer; three trials per hand averaged.
Measured: Pre- and post-intervention (4 weeks)
Global disability - modified Rankin Scale (mRS)
The Modified Rankin Scale (mRS) is a clinician-reported outcome measure of global disability following stroke. It assesses the level of functional independence, ranging from 0 (no symptoms) to 6 (death), and is widely used in clinical trials to evaluate overall outcome and disability. Score range: 0 to 6. Direction: Higher scores indicate greater disability (worse outcome)
Measured: Pre- and post-intervention (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study startMar 2012
- Primary completionJan 2015
- Study completionJul 2015
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.
- 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
- Model description
- This is a parallel assignment interventional study in which participants with chronic stroke are randomly assigned to one of two groups: (1) experimental group receiving motor imagery with real-time EEG-based brain-computer interface (BCI) neurofeedback, or (2) control group receiving motor imagery with sham feedback. Both groups undergo the same standardized physiotherapy program. Participants and outcome assessors are double-blinded to minimize bias. Each participant receives only one type of intervention throughout the four-week study period, allowing direct comparison of effects between real and sham neurofeedback while maintaining consistent training conditions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- CESPU-Escola Superior de Tecnologias da Saúde de Tâmega e Sousa
- Sponsor type
- University, hospital or other
- Collaborators
- ICVS - Life and Health Sciences Research Institute
- Responsible party
- Principal investigator, Raquel da Gloria Teixeira de Carvalho Ribeiro, CESPU-Escola Superior de Tecnologias da Saúde de Tâmega e Sousa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525609
- Sponsor's protocol ID
- NEURO-MI BCI Stroke
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 23 Apr 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 due to privacy and confidentiality concerns. The dataset contains detailed neurophysiological and behavioral measures from a small sample of chronic stroke patients, which could potentially allow identification of participants. Data sharing was also not included in the informed consent, and ethical approvals were obtained based on participant privacy protections.
Publications
Carvalho R, Azevedo E, Marques P, Dias N, Cerqueira JJ. Physiotherapy based on problem-solving in upper limb function and neuroplasticity in chronic stroke patients: A case series. J Eval Clin Pract. 2018 Jun;24(3):552-560. doi: 10.1111/jep.12921. Epub 2018 Apr 25.
PubMed 29691951
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback-guided Motor Imagery Using a Brain-Computer Interface in Chronic Stroke: a Controlled Pilot Study on Upper-limb Function and Brain Symmetry
- ClinicalTrials.gov ID
- NCT07525609
- Acronym / sponsor ID
- NEURO-MI BCI Stroke
- Conditions
- Stroke, Upper Limb Rehabilitation
- Keywords
- Brain-machine interface, Neuroplasticity, Physical therapy, Stroke Rehabilitation, Upper-limb recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- CESPU-Escola Superior de Tecnologias da Saúde de Tâmega e SousaUniversity, hospital or other
- Collaborators
- ICVS - Life and Health Sciences Research Institute
- Study start
- Mar 2012 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Apr 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.
Stroke can lead to long-term impairment of upper-limb function, particularly in the chronic phase, where recovery is often limited. Brain-computer interface (BCI) systems combined with motor imagery (MI) are emerging as promising neurorehabilitation approaches. Providing real-time neurofeedback during MI may enhance motor recovery by promoting use-dependent neuroplasticity; however, evidence in individuals with chronic stroke remains limited.
This controlled pilot study aims to evaluate the feasibility and preliminary effects of an EEG-based BCI neurofeedback intervention combined with MI and physiotherapy on upper-limb motor function and brain activation patterns in individuals with chronic stroke. Participants are assigned to either an experimental group receiving MI with real-time EEG-based neurofeedback or a control group receiving MI with sham feedback, alongside a standardized four-week physiotherapy program.
Motor function is assessed using validated clinical measures, including the Action Research Arm Test, Fugl-Meyer Assessment, Motor Assessment Scale, and grip strength, with changes interpreted according to clinically meaningful thresholds. Neurophysiological changes are explored through EEG-based measures of brain symmetry and task-related functional MRI.
It is expected that participants receiving real neurofeedback will show greater improvements in upper-limb function and more adaptive brain activation patterns compared to those receiving sham feedback. Findings from this study will help determine the feasibility of this approach and inform the design of larger trials to evaluate its effectiveness in chronic stroke rehabilitation.
Detailed description
This study follows a double-blind design in which both participants and outcome assessors are unaware of group allocation, minimizing potential sources of bias. The inclusion of a sham feedback condition is intended to control for nonspecific effects related to task engagement, attention, and exposure to the intervention environment.
The neurofeedback protocol is based on real-time modulation of EEG-derived sensorimotor rhythms during motor imagery tasks. In the experimental group, feedback is contingent on participants' brain activity, enabling reinforcement of targeted neural patterns. In the control group, feedback is non-contingent but visually similar, ensuring maintenance of blinding.
To ensure intervention fidelity, the protocol is delivered over a fixed duration with standardized procedures across participants. The integration of the neurofeedback intervention within a structured rehabilitation schedule is designed to minimize variability and support consistency in delivery.
Outcome interpretation incorporates minimal clinically important difference (MCID) thresholds to distinguish clinically meaningful improvements. In addition, the combined use of EEG and task-related functional MRI provides complementary insight into neuroplasticity, capturing both temporal dynamics and spatial patterns of brain reorganization.
Feasibility is further evaluated through indicators such as adherence to the intervention protocol, participant retention, and the practicality of implementing EEG-based neurofeedback in a rehabilitation context. These elements are intended to inform protocol optimization and the design of future randomized controlled trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a parallel assignment interventional study in which participants with chronic stroke are randomly assigned to one of two groups: (1) experimental group receiving motor imagery with real-time EEG-based brain-computer interface (BCI) neurofeedback, or (2) control group receiving motor imagery with sham feedback. Both groups undergo the same standardized physiotherapy program. Participants and outcome assessors are double-blinded to minimize bias. Each participant receives only one type of intervention throughout the four-week study period, allowing direct comparison of effects between real and sham neurofeedback while maintaining consistent training conditions.
| Arm | Type | Receives |
|---|---|---|
| Motor imagery-based training - Real Neurofeedback | Experimental | Other: Motor imagery-based training - Real NeurofeedbackParticipants perform motor imagery tasks combined with real-time EEG-based brain-computer interface (BCI) neurofeedback alongside a standardized four-week physiotherapy program. Feedback is contingent on participants' brain activity to reinforce sensorimotor activation patterns. |
| Motor imagery-based training - Sham Neurofeedback | Sham comparator | Other: Motor imagery-based training - Sham NeurofeedbackParticipants perform the same motor imagery tasks with sham (non-contingent) feedback alongside the same physiotherapy program. Feedback is visually similar but not based on actual brain activity, serving as a control for nonspecific effects of training. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged ≥18 years
- First-ever cortical ischemic stroke affecting the left middle cerebral artery (MCA) territory
- ≥12 months since stroke onset
- Stroke diagnosis confirmed by structural neuroimaging (MRI or CT)
- Lesion localization confirmed based on clinical and radiological criteria
Key exclusion criteria (9 listed)
- Complete hand plegia
- Presence of language or cognitive impairment, as assessed by the Montreal Cognitive Assessment (MoCA)
- Presence of attentional deficits
- Presence of visual impairments that may interfere with task performance
- Diagnosis of depression
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 training - Real NeurofeedbackAlso: Physiotherapy based on a problem-solving therapeutic modelParticipants completed 12 sessions of motor imagery (MI)-based training (30 minutes/session, 3× weekly) using an EEG-based BCI system (Emotiv® EPOC headset, 14 channels). During each session, participants imagined moving their right or left hand to push a virtual ball, guided by directional cues. Real-time neurofeedback of the ball movement was provided contingent on participants' brain activity. Each MI session was followed by a standardized physiotherapy session based on a problem-solving therapeutic model. | Other | Motor imagery-based training - Real Neurofeedback |
| Motor imagery-based training - Sham NeurofeedbackAlso: Physiotherapy based on a problem-solving therapeutic modelParticipants completed 12 sessions of motor imagery (MI)-based training (30 minutes/session, 3× weekly) using an EEG-based BCI system (Emotiv® EPOC headset, 14 channels). Participants completed the same MI-based training and physiotherapy schedule. During MI, they received sham feedback: pre-recorded visual feedback from previous sessions, not contingent on their brain activity. All other procedures, including trial structure, session frequency, and physiotherapy, were identical to the experimental group. | Other | Motor imagery-based training - Sham Neurofeedback |
Primary outcome
Neuroplasticity
Time frame: Pre- and post-intervention (4 weeks)
Assessed using combined EEG-fMRI measures. EEG was recorded with a 64-channel MRI-compatible system during motor execution (ME) and motor imagery (MI) tasks for both hands, with simultaneous fMRI acquisition. Brain symmetry index (BSI) was computed from mu (8-13 Hz) and beta (14-30 Hz) band activity in ipsilesional (C1, C3, FC1, FC3) and contralesional (C2, C4, FC2, FC4) motor cortical regions. fMRI data were acquired on a 3.0 Tesla scanner and analyzed using standard preprocessing and SPM8 to evaluate functional activation patterns.
5 secondary outcomes
Upper-limb motor function - Action Research Arm Test (ARAT)
Time frame: Pre- and post-intervention (4 weeks)
Upper-limb motor function - Fugl-Meyer Assessment - Upper Extremity. (FMA-UE)
Time frame: Pre- and post-intervention (4 weeks)
Upper-limb motor function - Motor Assessment Scale (MAS)
Time frame: Pre- and post-intervention (4 weeks)
Handgrip strength
Time frame: Pre- and post-intervention (4 weeks)
Global disability - modified Rankin Scale (mRS)
Time frame: Pre- and post-intervention (4 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 23 Apr 2026.
- Results publication: PubMed 29691951Carvalho R, Azevedo E, Marques P, Dias N, Cerqueira JJ. Physiotherapy based on problem-solving in upper limb function and neuroplasticity in chronic stroke patients: A case series. J Eval Clin Pract. 2018 Jun;24(3):552-560. doi: 10.1111/jep.12921. Epub 2018 Apr 25.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality concerns. The dataset contains detailed neurophysiological and behavioral measures from a small sample of chronic stroke patients, which could potentially allow identification of participants. Data sharing was also not included in the informed consent, and ethical approvals were obtained based on participant privacy protections.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Motor imagery-based training - Real Neurofeedback in people with Stroke and Upper Limb Rehabilitation, run by CESPU-Escola Superior de Tecnologias da Saúde de Tâmega e Sousa.
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 9 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 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Neuroplasticity (time frame: Pre- and post-intervention (4 weeks)). 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 NCT07525609, 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 23 Apr 2026.