Centro di Sclerosi Multipla dell'Azienda Ospedaliera Universitaria Federico II
Naples, Italia, 80125, Italy
Location contact
Antonio Esposito, PhD Researcher in Engineering
CONTACT
Roberta Lanzillo, Medical Doctor in Neurology
CONTACT
Not Yet Recruiting
NCT Number: NCT07472556
Using Motor Imagery-based Brain-computer Interface With Multiple Sclerosis Patients.
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).
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Brain Computer Interface
DeviceThe 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 outcomes
-
Modulation of ERD/ERS patterns during Motor Imagery (MI) tasks
Time frame: From baseline to week 12
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).
Secondary outcomes
-
System Usability and User Acceptance
Time frame: Week 12 (end of treatment)
Assess usability, satisfaction, and acceptability of the BCI-based neurofeedback system through the System Usability Scale (SUS) and participant feedback. Analyze correlations with functional clinical outcomes and evaluate potential for home-based telerehabilitation use.
Study contacts
Contact information is provided by the study sponsor or research team.
Antonio Esposito, PhD Researcher in Engineering
CONTACT
Roberta Lanzillo Lanzillo, Medical Doctor in Neurology
CONTACT
Sponsors and collaborators
Lead sponsor
Pasquale Arpaia
Other
Registry information
Official study title
Clinical Investigation Into the Use of a Motor Imagery-based Brain-computer Interface for Rehabilitation Support in Patients With Multiple Sclerosis.
Acronym: BCI_MI_SM_2026
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Mar 16, 2026
- Registry last updated
- Mar 16, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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