BCI With Virtual Reality for Stroke Rehabilitation: A Crossover Study

NCT07374276 | Recruiting

• 2 other identifiers: 1801P.0128710.54499/2022.02283.PTDC
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Stroke; Brain-Computer Interface; Virtual Reality; Motor Imagery; Upper Extremity; Rehabilitation

Outcome Measures

Primary Outcomes (5)

• Change in Upper Limb Motor Function (Fugl-Meyer Assessment - Upper Extremity)

  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.

  Baseline and end of each 6-week intervention period (up to 15 weeks total, including washout).

• Change in Upper Limb Activity (Action Research Arm Test - ARAT)

  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.

  Baseline and end of each 6-week intervention period (up to 15 weeks total, including washout).

• Change in EEG Event-Related Desynchronization/Synchronization (ERD/ERS)

  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.

  During each intervention session across both 6-week intervention periods (up to 15 weeks total, including washout).

• Change in EEG Hemispheric Lateralization Index

  Changes in EEG-derived hemispheric lateralization indices during motor imagery tasks, used to evaluate intervention-related reorganization of cortical motor networks.

  During each intervention session across both 6-week intervention periods (up to 15 weeks total, including washout).

• Change in EEG Connectivity Measures

  Exploratory changes in EEG-based functional connectivity metrics between motor-related cortical regions during motor imagery tasks.

  During each intervention session across both 6-week intervention periods (up to 15 weeks total, including washout).

Other Outcomes (7)

• Cognitive Function (Montreal Cognitive Assessment - MoCA)

  Baseline and end of each 6-week intervention period (up to 15 weeks total, including washout).

• Stroke Patient Participation (Stroke Impact Scale - SIS)

  Baseline and end of each 6-week intervention period (up to 15 weeks total, including washout).

• Depressive Symptoms (Patient Health Questionnaire-9 - PHQ-9)

  Baseline and end of each 6-week intervention period (up to 15 weeks total, including washout).

Study Arms (2)

MI-VR-BCI Training

EXPERIMENTAL

Participants will perform motor imagery-based brain-computer interface training combined with immersive virtual reality and multimodal feedback (visual, auditory, and haptic).

Device: Motor Imagery-based Brain-Computer Interface coupled with Virtual Reality (MI-BCI-VR)

MI-BCI

ACTIVE COMPARATOR

Participants will perform motor imagery-based brain-computer interface (MI-BCI) training based on a cue-based protocol.

Device: Motor Imagery-based Brain-Computer Interface (MI-BCI)

Interventions

Motor Imagery-based Brain-Computer Interface coupled with Virtual Reality (MI-BCI-VR) DEVICE

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.

MI-VR-BCI Training

Motor Imagery-based Brain-Computer Interface (MI-BCI) DEVICE

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.

MI-BCI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Technical University of Lisbon: lead
• Centro de Medicina de Reabilitação de Alcoitão: collaborator

Study Sites (1)

Centro de Medicina de Reabilitação de Alcoitão

Alcabideche, Lisbon District, 2649-506, Portugal

RECRUITING

Related Links

• NOISyS project webpage providing an overview of the project, including objectives, consortium members, and outputs.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Athanasios Vourvopoulos, PhD

CONTACT

+351218418289; athanasios.vourvopoulos@tecnico.ulisboa.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Each participant will complete two intervention periods, corresponding to two different intervention types (MI-VR-BCI or MI-BCI), administered in a randomized order. A 3-week washout period will separate the two intervention periods. Pre- and post-intervention assessments will be conducted for each period, resulting in a total of four assessments per participant.

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 28, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)