Brain-computer interface to support arm rehabilitation in people with multiple sclerosis
Tests a brain-computer interface for arm rehabilitation in adults with multiple sclerosis.
Plain-language title generated from the registry record
Registry title: Using Motor Imagery-based Brain-computer Interface With Multiple Sclerosis Patients.
Key facts
- Where
- Naples, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07472556, who can take part
Where in Italy
- Centro di Sclerosi Multipla dell'Azienda Ospedaliera Universitaria Federico IINaples, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pasquale Arpaia
- Trial code
- NCT07472556
- Record updated
- 16 March 2026
- Original description
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:Read full original descriptionShow less
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).
Inclusion: 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: 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; MMSE < 24.