NCT07472556

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Pasquale Arpaia · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2026-07-01
• Primary completion: 2026-09-30
• Completion: 2026-11-30
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: Italy