Motor Imagery-based Brain-Computer Interface coupled with Virtual Reality (MI-BCI-VR)Motor Imagery-based Brain-Computer Interface (MI-BCI)
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.
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.
Study 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. 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Change in Upper Limb Motor Function (Fugl-Meyer Assessment - Upper Extremity) — 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) — 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) — 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 — 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 — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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