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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurofeedback | 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. |
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| Controllo | No Intervention | Participants in this group will not receive any experimental therapy. They will continue their standard upper limb motor rehabilitation therapy, if included in their clinical care plan. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain Computer Interface | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Modulation of ERD/ERS patterns during Motor Imagery (MI) tasks | 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). | From baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| System Usability and User Acceptance | 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. | Week 12 (end of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberta Lanzillo Lanzillo, Medical Doctor in Neurology | Contact | +39 081 746 3741 | roberta.lanzillo@unina.it | |
| Antonio Esposito, PhD Researcher in Engineering | Contact | antonio.esposito9@unina.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro di Sclerosi Multipla dell'Azienda Ospedaliera Universitaria Federico II | Naples | Italia | 80125 | Italy |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D062207 | Brain-Computer Interfaces |
| ID | Term |
|---|---|
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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2 groups
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |