NCT07525609

Neurofeedback-Guided BCI Motor Imagery for Upper-Limb Recovery in Chronic Stroke

Neurofeedback-guided Motor Imagery Using a Brain-Computer Interface in Chronic Stroke: a Controlled Pilot Study on Upper-limb Function and Brain Symmetry

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: CESPU-Escola Superior de Tecnologias da Saúde de Tâmega e Sousa · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Stroke
• Upper Limb Rehabilitation

Interventions

Type	Name	Description
OTHER	Motor imagery-based training - Real Neurofeedback	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.
OTHER	Motor imagery-based training - Sham Neurofeedback	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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-01-01
• Completion: 2015-07-01
• First posted: 2026-04-13
• Last updated: 2026-04-13