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

N/ANot Yet RecruitingNCT07472556

Pasquale Arpaia40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Modulation of ERD/ERS patterns during Motor Imagery (MI) tasks

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).

Time frame: From baseline to week 12

Secondary Outcomes

System Usability and User Acceptance

Assess usability, satisfaction, and acceptability of the BCI-based neurofeedback system through the System Usability Scale (SUS) and participant feedback. Analyze correlations with functional clinical outcomes and evaluate potential for home-based telerehabilitation use.

Time frame: Week 12 (end of treatment)