NCT07472556Not yet recruiting
Using Motor Imagery-based Brain-computer Interface With Multiple Sclerosis Patients.
Clinical Investigation Into the Use of a Motor Imagery-based Brain-computer Interface for Rehabilitation Support in Patients With Multiple Sclerosis.
Source: ClinicalTrials.gov · Last updated 16 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 9 Mar 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Pasquale Arpaia
- Diseases
- Multiple sclerosis
- NCT number
- NCT07472556
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Jul 2026 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- MMSE \< 24
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro di Sclerosi Multipla dell'Azienda Ospedaliera Universitaria Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.