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

NCT07472556 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-16

No results posted yet for this 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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Pasquale Arpaia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-09-30
Completion
2026-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07472556 on ClinicalTrials.gov