Using Motor Imagery-based Brain-computer Interface With Multiple Sclerosis Patients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brain Computer Interface.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Investigation Into the Use of a Motor Imagery-based Brain-computer Interface for Rehabilitation Support in Patients With Multiple Sclerosis.
Overview
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).
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.
Primary outcome measures
- Modulation of ERD/ERS patterns during Motor Imagery (MI) tasks [Time frame: From baseline to week 12]
Secondary outcome measures (1)
- System Usability and User Acceptance [Time frame: Week 12 (end of treatment)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Centro di Sclerosi Multipla dell'Azienda Ospedaliera Universitaria Federico II — Naples
Identifiers
NCT: NCT07472556 · BCI_MI_SM_2026