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BCI_MI_SM_2026Brain-Computer Interface for Upper Limb Motor Rehabilitation in Multiple Sclerosis

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Study Aim

This study aims to evaluate how well a Brain-Computer Interface (BCI) neurofeedback protocol enhances your ability to control specific brain activity patterns during upper limb motor imagery tasks, if you are a patient with Multiple Sclerosis.

What is being tested

Brain Computer Interface

Device
Who is being recruted

Autoimmune Diseases+4

+ Demyelinating Diseases

+ Immune System Diseases

From 18 to 60 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2026
See protocol details

Summary

Principal SponsorPasquale Arpaia
Study ContactRoberta Lanzillo Lanzillo, Medical Doctor in NeurologyMore contacts
Last updated: March 17, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2026

Actual date on which the first participant was enrolled.

This clinical trial focuses on evaluating a wearable brain-computer interface (BCI) system that uses motor imagery (MI) to support upper limb rehabilitation in patients with Multiple Sclerosis (MS). The main aim is to understand if this BCI system can enhance the voluntary control of brain signals during MI tasks in MS patients. Additionally, the study seeks to determine if this system is user-friendly, acceptable, and suitable for remote rehabilitation. The trial is particularly important as it could pave the way for new methods to improve motor function in individuals with MS. Participants in this study will either receive BCI-based neurofeedback plus conventional motor therapy or only standard rehabilitation. Those in the experimental group will attend 24 neurofeedback sessions over 12 weeks, performing EEG-based motor imagery tasks with visual and haptic feedback in immersive extended reality. All participants will complete evaluations at baseline, 6 weeks, 12 weeks, and 1-month post-treatment, which include assessments of motor imagery ability, manual dexterity, perceived fatigue, and system usability. The primary outcome is to measure the improvement in the modulation of brain signals during MI tasks.

Official TitleClinical Investigation Into the Use of a Motor Imagery-based Brain-computer Interface for Rehabilitation Support in Patients With Multiple Sclerosis.
Principal SponsorPasquale Arpaia
Study ContactRoberta Lanzillo Lanzillo, Medical Doctor in NeurologyMore contacts
Last updated: March 17, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDemyelinating DiseasesImmune System DiseasesMultiple SclerosisNervous System DiseasesAutoimmune Diseases of the Nervous SystemDemyelinating Autoimmune Diseases, CNS

Criteria

6 inclusion criteria required to participate
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

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5 exclusion criteria prevent from participating
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)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Centro di Sclerosi Multipla dell'Azienda Ospedaliera Universitaria Federico II

Napoli, ItalyOpen Centro di Sclerosi Multipla dell'Azienda Ospedaliera Universitaria Federico II in Google Maps
Recruiting soonOne Study Center