An interventional study of BCI sessions with neurofeedback and BCI sessions without neurofeedback in Stroke, Brain Computer Interface and Motor Imagery, sponsored by Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia. Enrolling by invitation at 1 site in Argentina. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia · Not applicable, Interventional, and Health services research
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.
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
with performance feedback in the movement imagery during the video game that helps the learning process in operating a BCI
Device: BCI sessions with neurofeedback
without performance feedback in the movement imagery during the video game
Device: BCI sessions without neurofeedback
10 video game sessions using a brain-computer interface (BCI) with real time performance neurofeedback
10 video game sessions using a brain-computer interface (BCI) without real time performance neurofeedback
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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 3 weeks
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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 3 weeks
Plan to share: Undecided — Only IPDs used for the publication of the results will be included.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia