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

NCT07525609 | Completed

• 1 other identifier: NEURO-MI BCI Stroke
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke; Upper Limb Rehabilitation

Keywords

Brain-machine interface; Neuroplasticity; Physical therapy; Stroke Rehabilitation; Upper-limb recovery

Outcome Measures

Primary Outcomes (1)

• Neuroplasticity

  Assessed using combined EEG-fMRI measures. EEG was recorded with a 64-channel MRI-compatible system during motor execution (ME) and motor imagery (MI) tasks for both hands, with simultaneous fMRI acquisition. Brain symmetry index (BSI) was computed from mu (8-13 Hz) and beta (14-30 Hz) band activity in ipsilesional (C1, C3, FC1, FC3) and contralesional (C2, C4, FC2, FC4) motor cortical regions. fMRI data were acquired on a 3.0 Tesla scanner and analyzed using standard preprocessing and SPM8 to evaluate functional activation patterns.

  Pre- and post-intervention (4 weeks)

Secondary Outcomes (5)

• Upper-limb motor function - Action Research Arm Test (ARAT)

  Pre- and post-intervention (4 weeks)

• Upper-limb motor function - Fugl-Meyer Assessment - Upper Extremity. (FMA-UE)

  Pre- and post-intervention (4 weeks)

• Upper-limb motor function - Motor Assessment Scale (MAS)

  Pre- and post-intervention (4 weeks)

• Handgrip strength

  Pre- and post-intervention (4 weeks)

• Global disability - modified Rankin Scale (mRS)

  Pre- and post-intervention (4 weeks)

Study Arms (2)

Motor imagery-based training - Real Neurofeedback

EXPERIMENTAL

Participants perform motor imagery tasks combined with real-time EEG-based brain-computer interface (BCI) neurofeedback alongside a standardized four-week physiotherapy program. Feedback is contingent on participants' brain activity to reinforce sensorimotor activation patterns.

Other: Motor imagery-based training - Real Neurofeedback

Motor imagery-based training - Sham Neurofeedback

SHAM COMPARATOR

Participants perform the same motor imagery tasks with sham (non-contingent) feedback alongside the same physiotherapy program. Feedback is visually similar but not based on actual brain activity, serving as a control for nonspecific effects of training.

Other: Motor imagery-based training - Sham Neurofeedback

Interventions

Motor imagery-based training - Real Neurofeedback OTHER

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.

Also known as: Physiotherapy based on a problem-solving therapeutic model

Motor imagery-based training - Real Neurofeedback

Motor imagery-based training - Sham Neurofeedback OTHER

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.

Also known as: Physiotherapy based on a problem-solving therapeutic model

Motor imagery-based training - Sham Neurofeedback

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 years
• First-ever cortical ischemic stroke affecting the left middle cerebral artery (MCA) territory
• ≥12 months since stroke onset
• Stroke diagnosis confirmed by structural neuroimaging (MRI or CT)
• Lesion localization confirmed based on clinical and radiological criteria

You may not qualify if:

• Complete hand plegia
• Presence of language or cognitive impairment, as assessed by the Montreal Cognitive Assessment (MoCA)
• Presence of attentional deficits
• Presence of visual impairments that may interfere with task performance
• Diagnosis of depression
• Pre-stroke dependence in activities of daily living
• Left-handedness, as assessed by the Edinburgh Handedness Inventory
• Inability to perform motor imagery tasks
• Contraindications to MRI (e.g., metallic implants, implanted electronic devices, or claustrophobia)

Sponsors & Collaborators

• ICVS - Life and Health Sciences Research Institute: collaborator
• CESPU-Escola Superior de Tecnologias da Saúde de Tâmega e Sousa: lead

Related Publications (1)

• Carvalho R, Azevedo E, Marques P, Dias N, Cerqueira JJ. Physiotherapy based on problem-solving in upper limb function and neuroplasticity in chronic stroke patients: A case series. J Eval Clin Pract. 2018 Jun;24(3):552-560. doi: 10.1111/jep.12921. Epub 2018 Apr 25.

  PMID: 29691951 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study design includes double blinding, in which participants and outcome assessors are unaware of group allocation. This approach minimizes potential bias from expectation effects, observer influence, or differences in engagement between groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Auxiliar Professor

Model Details: This is a parallel assignment interventional study in which participants with chronic stroke are randomly assigned to one of two groups: (1) experimental group receiving motor imagery with real-time EEG-based brain-computer interface (BCI) neurofeedback, or (2) control group receiving motor imagery with sham feedback. Both groups undergo the same standardized physiotherapy program. Participants and outcome assessors are double-blinded to minimize bias. Each participant receives only one type of intervention throughout the four-week study period, allowing direct comparison of effects between real and sham neurofeedback while maintaining consistent training conditions.

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 13, 2026
• Study Start: March 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share