NCT07374276

BCI With Virtual Reality for Stroke Rehabilitation: A Crossover Study

Brain-Computer Interface (BCI) With Virtual Reality (VR) in Upper Limb Rehabilitation After Stroke: A Randomized Crossover Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Technical University of Lisbon · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	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	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.

Timeline

• Start date: 2026-01-05
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2026-01-28
• Last updated: 2026-02-03

Locations

1 site across 1 country: Portugal