StrokeNCT07875257
Evaluation of an Adaptive Neurotechnology Based on Motor Imagery in Patients Who Suffered a Left Hemisphere Stroke
A study testing BCI sessions with neurofeedback and BCI sessions without neurofeedback in people with Stroke and Brain Computer Interface, run by Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia at 1 site in Argentina.
Trial summary
This randomized clinical trial will evaluate the feasibility and performance of a co-adaptive motor imagery brain-computer interface (BCI) for upper-limb rehabilitation in adults with subacute left-hemisphere stroke. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke, Brain Computer Interface, Motor Imagery
- What is being tested?
- BCI sessions with neurofeedback and BCI sessions without neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Oct 2026to Oct 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years;
- Medical diagnosis of a first left hemisphere stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) or clinical evaluation;
- Stroke occurred within the last 90 days;
- Brunnstrom recovery stage III-V for the upper limb and Brunnstrom recovery stage II-V for the hand;
- Ashworth score ≤2 in elbow flexors and finger flexors;
- Score in the attention/executive function dimension of the Montreal Cognitive Assessment (MoCA): ≥ 3;
- Mild to moderate aphasia: on the NIHSS scale, aphasia subscore ≤2 points;
- No right homonymous hemianopia as determined by visual field confrontation.
Who cannot join
- Individuals with a neurological or psychiatric condition that would preclude participation in the study;
- Individuals with a history of trauma or rheumatological conditions affecting the mobility of the right upper limb;
- Individuals with skin damage at the electrode contact point, infection, or allergy to the electrodes;
- Patients with tracheostomies, intracranial metallic implants, metallic pacemakers, or craniotomies;
- Individuals with any medical contraindication to participating in the protocol;
- Individuals not currently participating in an upper limb research protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This randomized clinical trial will evaluate the feasibility and performance of a co-adaptive motor imagery brain-computer interface (BCI) for upper-limb rehabilitation in adults with subacute left-hemisphere stroke. The study will investigate whether continuous neurofeedback improves BCI control and learning compared with binary feedback based on correct or incorrect task performance. Participants will be randomly assigned to a neurofeedback group or a group receiving binary feedback. The intervention consists of BCI calibration followed by 10 real-time BCI training sessions. EEG and surface EMG signals will be recorded throughout the BCI sessions. BCI performance will be assessed using decoding accuracy and the algorithmic support provided by the Supportive Backward Adaptation (SBA) method, together with motor and neurophysiological measures.
Read the detailed description
Brain-computer interfaces (BCIs) based on motor imagery provide a means of translating patterns of brain activity into artificial control signals and may be used as a complementary technology for upper-limb motor rehabilitation after stroke. Surface electroencephalography (EEG) is a non-invasive method for recording brain activity during motor imagery. However, BCI performance may vary across sessions because of changes in the user's ability to perform the mental task and variability in EEG signals.
This study will evaluate coAR.BCI (coAdaptive Rehabilitative BCI), a co-adaptive motor imagery BCI developed for upper-limb rehabilitation. The system incorporates Supportive Backward Adaptation (SBA), an adaptive decoding approach designed to account for changes in EEG patterns across sessions. The study will also evaluate a neurofeedback strategy intended to provide participants with continuous information regarding their performance during motor imagery.
This is a randomized clinical trial including 12 adults with a first supratentorial left-hemisphere stroke in the subacute phase. Participants will be randomly assigned to one of two groups: a neurofeedback group or a control group receiving binary feedback without neurofeedback.
The study comprises an initial motor assessment, a BCI calibration session, 10 BCI application sessions, and a final motor assessment. During BCI sessions, participants will perform motor imagery of hand opening and closing and a relaxation/no-movement condition while interacting with a computer-based avatar. The task consists of attempting to collect coins using the imagined movement of the hand. EEG will be recorded using 15 electrodes over sensorimotor cortical areas. Surface electromyography (EMG) will also be recorded from finger flexor muscles.
In the neurofeedback group, participants will receive feedback regarding the quality of their motor imagery performance in addition to feedback indicating whether the detected mental task was correct. In the control group, participants will receive binary corrective feedback without the additional neurofeedback component.
BCI performance will be evaluated throughout the intervention using decoding accuracy and the algorithmic support provided by the SBA method. Neurophysiological measures, including EEG spectral features and activation patterns, will also be analyzed. Motor function will be assessed before and after the intervention using the Fugl-Meyer Assessment for the upper limb, Wolf Motor Function Test, and Modified Ashworth Scale.
The study will also collect clinical-demographic variables and pre- and post-session measures related to perceived anxiety, rest, mental effort, fatigue, and intrinsic motivation.
The study is designed to investigate the feasibility and learning process associated with the use of a co-adaptive BCI and to examine differences in BCI control and adaptation between participants receiving continuous neurofeedback and those receiving binary feedback.
- Conditions
- Stroke, Brain Computer Interface, Motor Imagery, Neurofeedback, Upper Extremity, Rehabilitation
- Being tested
- BCI sessions with neurofeedback, BCI sessions without neurofeedback
- Keywords
- Brain-Computer Interface, Motor Imagery Neurofeedback, Neurofeedback, Stroke Rehabilitation, Upper Limb Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCI sessions with neurofeedbackDevice
10 video game sessions using a brain-computer interface (BCI) with real time performance neurofeedback
BCI sessions without neurofeedbackDevice
10 video game sessions using a brain-computer interface (BCI) without real time performance neurofeedback
| Study group | Role | What they receive |
|---|---|---|
| BCI with neurofeedback | Experimental | with performance feedback in the movement imagery during the video game that helps the learning process in operating a BCI Receives: Device: BCI sessions with neurofeedback |
| BCI without neurofeedback | Other | without performance feedback in the movement imagery during the video game Receives: Device: BCI sessions without neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Assessment
The Fugl-Meyer Assessment (FMA) is a standardized, performance-based clinical scale used to evaluate motor impairment and recovery after stroke. It assesses motor function of the upper and lower extremities, as well as other domains such as sensory function, balance, joint range of motion, and joint pain.
The motor component is divided into upper-extremity and lower-extremity sections and evaluates movement, reflex activity, coordination, and speed. Each item is typically scored on a 3-point ordinal scale: 0 = cannot perform, 1 = performs partially, and 2 = performs fully.
The FMA is widely used in stroke rehabilitation to quantify motor impairment, monitor changes over time, and evaluate treatment outcomes. Higher scores indicate better motor and functional performance.
Measured: From enrollment to the end of treatment at 3 weeks
Wolf Motor Function Test
The Wolf Motor Function Test (WMFT) is a standardized clinical assessment used to evaluate upper-extremity motor ability in individuals with neurological conditions, particularly after stroke. It measures both movement quality and the time required to complete functional and strength-based tasks.
The test includes a series of tasks involving the arm and hand, such as lifting objects, reaching, grasping, and performing functional movements. Performance is commonly evaluated using task completion time and a functional ability rating, which reflects the quality of movement.
The WMFT is widely used in stroke rehabilitation to quantify upper-limb motor impairment, monitor changes over time, and assess the effectiveness of rehabilitation interventions. Shorter completion times and higher functional ability scores indicate better performance.
Measured: From enrollment to the end of treatment at 3 weeks
Secondary outcomes (2)
Electroencephalography (EEG)
Electroencephalography (EEG) will be recorded across the sessions. EEG from 13 electrode positions covering the sensorimotor area will be registered.
From the EEG different outcome measures will be assessed: event related desynchronization (ERD), event related resynchronization (ERD), periodic alpha power, periodic beta power, aperiodic component, signed R2, as well as P300 component changes across sessions.
Measured: From enrollment to the end of treatment at 3 weeks
Electromyography (EMG)
Electromyography (EMG) will be recorded across the sessions. EMG from a finger extensor muscle will be recorded, this biosignal will only be used for controlling purposes: checking for voluntary or involuntary moments associated with the motor imagery tasks.
Measured: From enrollment to the end of treatment at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Oct 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanina Lado, Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875257
- Sponsor's protocol ID
- 067/2018
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Only IPDs used for the publication of the results will be included.
Publications
Peterson V, Spagnolo V, Galvan CM, Nieto N, Spies RD, Milone DH. Towards subject-centered co-adaptive brain-computer interfaces based on backward optimal transport. J Neural Eng. 2025 Jul 8;22(4). doi: 10.1088/1741-2552/addb7a.
PubMed 40398442Liao W, Li J, Zhang X, Li C. Motor imagery brain-computer interface rehabilitation system enhances upper limb performance and improves brain activity in stroke patients: A clinical study. Front Hum Neurosci. 2023 Mar 14;17:1117670. doi: 10.3389/fnhum.2023.1117670. eCollection 2023.
PubMed 36999132Dussard C, Pillette L, Dumas C, Pierrieau E, Hugueville L, Lau B, Jeunet-Kelway C, George N. Influence of feedback transparency on motor imagery neurofeedback performance: the contribution of agency. J Neural Eng. 2024 Oct 9;21(5). doi: 10.1088/1741-2552/ad7f88.
PubMed 39321834
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Adaptive Neurotechnology Based on Motor Imagery in Patients Who Suffered a Left Hemisphere Stroke
- ClinicalTrials.gov ID
- NCT07875257
- Acronym / sponsor ID
- 067/2018
- Conditions
- Stroke, Brain Computer Interface, Motor Imagery, Neurofeedback, Upper Extremity, Rehabilitation
- Keywords
- Brain-Computer Interface, Motor Imagery Neurofeedback, Neurofeedback, Stroke Rehabilitation, Upper Limb Rehabilitation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundación para la Lucha contra las Enfermedades Neurológicas de la InfanciaUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 15 Oct 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.
This randomized clinical trial will evaluate the feasibility and performance of a co-adaptive motor imagery brain-computer interface (BCI) for upper-limb rehabilitation in adults with subacute left-hemisphere stroke. The study will investigate whether continuous neurofeedback improves BCI control and learning compared with binary feedback based on correct or incorrect task performance. Participants will be randomly assigned to a neurofeedback group or a group receiving binary feedback. The intervention consists of BCI calibration followed by 10 real-time BCI training sessions. EEG and surface EMG signals will be recorded throughout the BCI sessions. BCI performance will be assessed using decoding accuracy and the algorithmic support provided by the Supportive Backward Adaptation (SBA) method, together with motor and neurophysiological measures.
Detailed description
Brain-computer interfaces (BCIs) based on motor imagery provide a means of translating patterns of brain activity into artificial control signals and may be used as a complementary technology for upper-limb motor rehabilitation after stroke. Surface electroencephalography (EEG) is a non-invasive method for recording brain activity during motor imagery. However, BCI performance may vary across sessions because of changes in the user's ability to perform the mental task and variability in EEG signals.
This study will evaluate coAR.BCI (coAdaptive Rehabilitative BCI), a co-adaptive motor imagery BCI developed for upper-limb rehabilitation. The system incorporates Supportive Backward Adaptation (SBA), an adaptive decoding approach designed to account for changes in EEG patterns across sessions. The study will also evaluate a neurofeedback strategy intended to provide participants with continuous information regarding their performance during motor imagery.
This is a randomized clinical trial including 12 adults with a first supratentorial left-hemisphere stroke in the subacute phase. Participants will be randomly assigned to one of two groups: a neurofeedback group or a control group receiving binary feedback without neurofeedback.
The study comprises an initial motor assessment, a BCI calibration session, 10 BCI application sessions, and a final motor assessment. During BCI sessions, participants will perform motor imagery of hand opening and closing and a relaxation/no-movement condition while interacting with a computer-based avatar. The task consists of attempting to collect coins using the imagined movement of the hand. EEG will be recorded using 15 electrodes over sensorimotor cortical areas. Surface electromyography (EMG) will also be recorded from finger flexor muscles.
In the neurofeedback group, participants will receive feedback regarding the quality of their motor imagery performance in addition to feedback indicating whether the detected mental task was correct. In the control group, participants will receive binary corrective feedback without the additional neurofeedback component.
BCI performance will be evaluated throughout the intervention using decoding accuracy and the algorithmic support provided by the SBA method. Neurophysiological measures, including EEG spectral features and activation patterns, will also be analyzed. Motor function will be assessed before and after the intervention using the Fugl-Meyer Assessment for the upper limb, Wolf Motor Function Test, and Modified Ashworth Scale.
The study will also collect clinical-demographic variables and pre- and post-session measures related to perceived anxiety, rest, mental effort, fatigue, and intrinsic motivation.
The study is designed to investigate the feasibility and learning process associated with the use of a co-adaptive BCI and to examine differences in BCI control and adaptation between participants receiving continuous neurofeedback and those receiving binary feedback.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| BCI with neurofeedback | Experimental | Device: BCI sessions with neurofeedbackwith performance feedback in the movement imagery during the video game that helps the learning process in operating a BCI |
| BCI without neurofeedback | Other | Device: BCI sessions without neurofeedbackwithout performance feedback in the movement imagery during the video game |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 65 years;
- Medical diagnosis of a first left hemisphere stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) or clinical evaluation;
- Stroke occurred within the last 90 days;
- Brunnstrom recovery stage III-V for the upper limb and Brunnstrom recovery stage II-V for the hand;
- Ashworth score ≤2 in elbow flexors and finger flexors;
Key exclusion criteria (6 listed)
- Individuals with a neurological or psychiatric condition that would preclude participation in the study;
- Individuals with a history of trauma or rheumatological conditions affecting the mobility of the right upper limb;
- Individuals with skin damage at the electrode contact point, infection, or allergy to the electrodes;
- Patients with tracheostomies, intracranial metallic implants, metallic pacemakers, or craniotomies;
- Individuals with any medical contraindication to participating in the protocol;
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 |
|---|---|---|
| BCI sessions with neurofeedback10 video game sessions using a brain-computer interface (BCI) with real time performance neurofeedback | Device | BCI with neurofeedback |
| BCI sessions without neurofeedback10 video game sessions using a brain-computer interface (BCI) without real time performance neurofeedback | Device | BCI without neurofeedback |
Primary outcome
Fugl Meyer Assessment
Time frame: From enrollment to the end of treatment at 3 weeks
The Fugl-Meyer Assessment (FMA) is a standardized, performance-based clinical scale used to evaluate motor impairment and recovery after stroke. It assesses motor function of the upper and lower extremities, as well as other domains such as sensory function, balance, joint range of motion, and joint pain. The motor component is divided into upper-extremity and lower-extremity sections and evaluates movement, reflex activity, coordination, and speed. Each item is typically scored on a 3-point ordinal scale: 0 = cannot perform, 1 = performs partially, and 2 = performs fully. The FMA is widely used in stroke rehabilitation to quantify motor impairment, monitor changes over time, and evaluate treatment outcomes. Higher scores indicate better motor and functional performance.
Wolf Motor Function Test
Time frame: From enrollment to the end of treatment at 3 weeks
The Wolf Motor Function Test (WMFT) is a standardized clinical assessment used to evaluate upper-extremity motor ability in individuals with neurological conditions, particularly after stroke. It measures both movement quality and the time required to complete functional and strength-based tasks. The test includes a series of tasks involving the arm and hand, such as lifting objects, reaching, grasping, and performing functional movements. Performance is commonly evaluated using task completion time and a functional ability rating, which reflects the quality of movement. The WMFT is widely used in stroke rehabilitation to quantify upper-limb motor impairment, monitor changes over time, and assess the effectiveness of rehabilitation interventions. Shorter completion times and higher functional ability scores indicate better performance.
2 secondary outcomes
Electroencephalography (EEG)
Time frame: From enrollment to the end of treatment at 3 weeks
Electromyography (EMG)
Time frame: From enrollment to the end of treatment at 3 weeks
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 15 Oct 2026.
- Background: PubMed 40398442Peterson V, Spagnolo V, Galvan CM, Nieto N, Spies RD, Milone DH. Towards subject-centered co-adaptive brain-computer interfaces based on backward optimal transport. J Neural Eng. 2025 Jul 8;22(4). doi: 10.1088/1741-2552/addb7a.
- Background: PubMed 36999132Liao W, Li J, Zhang X, Li C. Motor imagery brain-computer interface rehabilitation system enhances upper limb performance and improves brain activity in stroke patients: A clinical study. Front Hum Neurosci. 2023 Mar 14;17:1117670. doi: 10.3389/fnhum.2023.1117670. eCollection 2023.
- Background: PubMed 39321834Dussard C, Pillette L, Dumas C, Pierrieau E, Hugueville L, Lau B, Jeunet-Kelway C, George N. Influence of feedback transparency on motor imagery neurofeedback performance: the contribution of agency. J Neural Eng. 2024 Oct 9;21(5). doi: 10.1088/1741-2552/ad7f88.
- Individual participant dataSharing planned: Undecided. Only IPDs used for the publication of the results will be included.
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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.
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 BCI sessions with neurofeedback and BCI sessions without neurofeedback in people with Stroke and Brain Computer Interface, run by Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia at 1 site in Argentina.
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 6 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: enrolling by invitation, as of the sponsor's last update on 15 Oct 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 Argentina. 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?
Fugl Meyer Assessment (time frame: From enrollment to the end of treatment at 3 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 NCT07875257, 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 15 Oct 2026.