Skip to main content
OpenTrials
Completed

NCT Number: NCT07525609

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Upper Limb Rehabilitation Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Other names: Physiotherapy based on a problem-solving therapeutic model

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.

Other names: Physiotherapy based on a problem-solving therapeutic model

Primary outcomes

  1. Neuroplasticity

    Time frame: Pre- and post-intervention (4 weeks)

    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.

Secondary outcomes

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

    Time frame: Pre- and post-intervention (4 weeks)

    Functional assessment of upper-limb dexterity. Scored independently by two blinded raters from video recordings. Score range: 0 to 57. Direction: Higher scores indicate better upper limb function.

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

    Time frame: Pre- and post-intervention (4 weeks)

    Fugl-Meyer Assessment - Upper Extremity. The FMA-UE is a stroke-specific, impairment-based subscale of the Fugl-Meyer Assessment that evaluates motor function of the upper extremity, including reflex activity, voluntary movement within and out of synergy patterns, coordination, and speed. It is widely used to quantify motor recovery following stroke. Score range: 0 to 66. Direction: Higher scores indicate less motor impairment (better upper limb function). Summary description:

  3. Upper-limb motor function - Motor Assessment Scale (MAS)

    Time frame: Pre- and post-intervention (4 weeks)

    Motor Assessment Scale - Upper Limb Items. This subset of the Motor Assessment Scale includes the upper limb-related items (upper arm function, hand movements, and advanced hand activities). Each item is scored from 0 to 6, providing a focused assessment of functional motor performance of the upper limb in individuals post-stroke. Score range: 0 to 18. Direction: Higher scores indicate better upper limb motor function

  4. Handgrip strength

    Time frame: Pre- and post-intervention (4 weeks)

    Measured using a Baseline® Hydraulic Hand Dynamometer; three trials per hand averaged.

  5. Global disability - modified Rankin Scale (mRS)

    Time frame: Pre- and post-intervention (4 weeks)

    The Modified Rankin Scale (mRS) is a clinician-reported outcome measure of global disability following stroke. It assesses the level of functional independence, ranging from 0 (no symptoms) to 6 (death), and is widely used in clinical trials to evaluate overall outcome and disability. Score range: 0 to 6. Direction: Higher scores indicate greater disability (worse outcome)

Sponsors and collaborators

Lead sponsor

CESPU-Escola Superior de Tecnologias da Saúde de Tâmega e Sousa

Other

Collaborators

  • ICVS - Life and Health Sciences Research Institute

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 13, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.