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

NCT07472556 | Not Yet Recruiting

• 1 other identifier: BCI_MI_SM_2026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis

Keywords

Brain-Computer interface; Motor imagery; Multiple sclerosis; Neurofeedback; Motor rehabilitation

Outcome Measures

Primary Outcomes (1)

• Modulation of ERD/ERS patterns during Motor Imagery (MI) tasks

  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 Outcomes (1)

• System Usability and User Acceptance

  Week 12 (end of treatment)

Study Arms (2)

Neurofeedback

EXPERIMENTAL

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

Controllo

NO INTERVENTION

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.

Interventions

Brain Computer Interface DEVICE

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.

Neurofeedback

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pasquale Arpaia: lead

Study Sites (1)

Centro di Sclerosi Multipla dell'Azienda Ospedaliera Universitaria Federico II

Naples, Italia, 80125, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Central Study Contacts

Roberta Lanzillo Lanzillo, Medical Doctor in Neurology

CONTACT

+39 081 746 3741; roberta.lanzillo@unina.it

Antonio Esposito, PhD Researcher in Engineering

CONTACT

antonio.esposito9@unina.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor of Electrical and Electronic Measurements at the Department of Electrical Engineering and Information Technologies (DIETI) and Director of the Interdepartmental Research Center in Healthcare Management and Healthcare Innovation (CIRMIS)

Model Details: 2 groups

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

IT (1)