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

Not Yet RecruitingNA

Sponsor: Pasquale Arpaia

Conditions: Multiple Sclerosis

Interventions: Brain Computer Interface

Countries: Italy

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Naples, Italia, Italy