Clinical Investigation Into the Use of a Motor Imagery-based Brain-computer Interface for Rehabilitation Support in Patients With Multiple Sclerosis.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Modulation of ERD/ERS patterns during Motor Imagery (MI) tasks
Study Overview
Brief Summary
The goal of this clinical trial is to evaluate the effectiveness of a wearable brain-computer interface (BCI)-based neurofeedback system using motor imagery (MI) to support upper limb motor rehabilitation in patients with Multiple Sclerosis (MS). The main questions it aims to answer are:
Does BCI-mediated neurofeedback enhance the voluntary modulation of sensorimotor rhythms (ERD/ERS) during motor imagery tasks in MS patients?
Is the proposed BCI system usable, acceptable, and potentially suitable for telerehabilitation contexts?
Researchers will compare a group undergoing BCI-based neurofeedback plus conventional motor therapy with a control group receiving only standard rehabilitation, to determine whether the intervention leads to superior EEG modulation and clinical outcomes.
Participants will:
Undergo 24 neurofeedback sessions over 12 weeks (2 per week), (experimental group), or do not receive any therapy (control group);
Complete baseline and follow-up evaluations (6 weeks, 12 weeks, and 1-month post-treatment) including motor imagery ability (MIQ-3), manual dexterity (9-Hole Peg Test, AMSQ), perceived fatigue (FSS), and usability (SUS);
Perform EEG-based motor imagery tasks with visual and haptic feedback in immersive extended reality (experimental group only).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of multiple sclerosis according to McDonald criteria 2017 (Thompson, 2018)
- •Age between 18 and 60 years
- •No clinical or radiological relapses in the 3 months prior to enrollment
- •Mild spasticity, defined as a score ≤1 on the Modified Ashworth Scale
- •Preserved cognitive function, defined as MMSE ≥ 24
- •Ability to understand and independently sign informed consent
Exclusion Criteria
- •MMSE < 24
- •Presence of neurological or psychiatric comorbidities that may interfere with the intervention or understanding of procedures
- •Severe visual deficits or upper limb orthopedic conditions preventing task execution or EEG cap use
- •Dermatological, cranial, or other conditions contraindicating EEG cap use (e.g., active scalp lesions, known allergy to electrode materials, recent neurosurgical procedures)
- •Any clinical condition deemed by the physician to be incompatible with participation or patient safety
Arms & Interventions
Neurofeedback
Participants in this group will receive 24 sessions (2 per week for 12 weeks) of Motor Imagery (MI)-based Brain-Computer Interface (BCI) training with real-time multimodal neurofeedback in extended reality.
Intervention: Brain Computer Interface (Device)
Controllo
Participants in this group will not receive any experimental therapy. They will continue their standard upper limb motor rehabilitation therapy, if included in their clinical care plan.
Outcomes
Primary Outcomes
Modulation of ERD/ERS patterns during Motor Imagery (MI) tasks
Time Frame: From baseline to week 12
Evaluate the efficacy of a Brain-Computer Interface (BCI)-based neurofeedback protocol in enhancing voluntary modulation of sensorimotor rhythms (Event-Related Desynchronization/Synchronization - ERD/ERS) during upper limb MI tasks in patients with Multiple Sclerosis (MS).
Secondary Outcomes
- System Usability and User Acceptance(Week 12 (end of treatment))
Investigators
Pasquale Arpaia
Full Professor of Electrical and Electronic Measurements at the Department of Electrical Engineering and Information Technologies (DIETI) and Director of the Interdepartmental Research Center in Healthcare Management and Healthcare Innovation (CIRMIS)
Federico II University