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Clinical Trials in Italy / NCT07472556
Starting soon Not applicable

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

NCT07472556 · tracked via the Priya Life Science Italy tracker
Sponsor
Pasquale Arpaia
Phase
Not applicable
Started
2026-07-01
Last updated
2026-03-16

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

Brain Computer Interface

Brain 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.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

  • 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).

Trial sites (1)

FacilityCityRegionStatus
Centro di Sclerosi Multipla dell'Azienda Ospedaliera Universitaria Federico II Naples Italia

Other trials for the same condition

Olfactory and Trigeminal Functions in Patients With Multiple Sclerosis: Case-control Study Starting soon
Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis Recruiting
Design and Validation of Innovative Strategies Based on Dual-Task Approach Active, not recruiting
A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis Active, not recruiting
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07472556 on ClinicalTrials.gov ↗ ← All trials in Italy