Multiple Sclerosis
Conditions
Keywords
Brain-Computer interface, Motor imagery, Multiple sclerosis, Neurofeedback, Motor rehabilitation
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).
Interventions
DEVICEBrain Computer Interface
The device used to deliver the Motor Imagery (MI)-based Brain-Computer Interface (BCI) training consists of a wearable EEG headset connected to a laptop that provides real-time multimodal neurofeedback in an extended reality environment.
Sponsors
Pasquale Arpaia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2 groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modulation of ERD/ERS patterns during Motor Imagery (MI) tasks | 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
| Measure | Time frame | Description |
|---|---|---|
| System Usability and User Acceptance | Week 12 (end of treatment) | 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. |
Countries
Italy
Contacts
CONTACTRoberta Lanzillo Lanzillo, Medical Doctor in Neurology
CONTACTAntonio Esposito, PhD Researcher in Engineering
Outcome results
None listed