Using Motor Imagery-based Brain-computer Interface With Multiple Sclerosis Patients.

Clinical Investigation Into the Use of a Motor Imagery-based Brain-computer Interface for Rehabilitation Support in Patients With Multiple Sclerosis.

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).

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