BCI_MI_SM_2026Brain-Computer Interface for Upper Limb Motor Rehabilitation in Multiple Sclerosis
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.
Brain Computer Interface
Autoimmune Diseases+4
+ Demyelinating Diseases
+ Immune System Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
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