Using Motor Imagery-based Brain-computer Interface With Multiple Sclerosis Patients. (BCI_MI_SM_2026)

March 13, 2026 updated by: Pasquale Arpaia

Clinical Investigation Into the Use of a Motor Imagery-based Brain-computer Interface for Rehabilitation Support in Patients With Multiple Sclerosis.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Roberta Lanzillo Lanzillo, Medical Doctor in Neurology
  • Phone Number: +39 081 746 3741
  • Email: roberta.lanzillo@unina.it

Study Contact Backup

Study Locations

  • Italy
    • Italia
      • Napoli, Italia, Italy, 80125
        • Centro di Sclerosi Multipla dell'Azienda Ospedaliera Universitaria Federico II
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neurofeedback
Participants in this group will receive 24 sessions (2 per week for 12 weeks) of Motor Imagery (MI)-based Brain-Computer Interface (BCI) training with real-time multimodal neurofeedback in extended reality.
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.
No Intervention: Controllo
Participants in this group will not receive any experimental therapy. They will continue their standard upper limb motor rehabilitation therapy, if included in their clinical care plan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modulation of ERD/ERS patterns during Motor Imagery (MI) tasks
Time Frame: 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).
From baseline to week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability and User Acceptance
Time Frame: 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.
Week 12 (end of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pasquale Arpaia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCI_MI_SM_2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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