Multiple SclerosisBCI_MI_SM_2026NCT07472556
Using Motor Imagery-based Brain-computer Interface With Multiple Sclerosis Patients.
A study testing Brain Computer Interface in people with Multiple Sclerosis, run by Pasquale Arpaia at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Brain Computer Interface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Roberta Lanzillo Lanzillo, Medical Doctor in Neurology contact
Antonio Esposito, PhD Researcher in Engineering contact
Italy1 site
Centro di Sclerosi Multipla dell'Azienda Ospedaliera Universitaria Federico II
Naples, Italia, 80125
Roberta Lanzillo, Medical Doctor in Neurology, +39 081 746 3741, roberta.lanzillo@unina.it
Antonio Esposito, PhD Researcher in Engineering, antonio.esposito9@unina.it
About this study
Official title: 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?
Read more
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).
- Conditions
- Multiple Sclerosis
- Being tested
- Brain Computer Interface
- Keywords
- Brain-Computer interface, Motor imagery, Multiple sclerosis, Neurofeedback, Motor rehabilitation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Computer InterfaceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Brain Computer Interface |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline to week 12
Secondary outcomes (1)
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.
Measured: Week 12 (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pasquale Arpaia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pasquale Arpaia, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472556
- Sponsor's protocol ID
- BCI_MI_SM_2026
- Acronym
- BCI_MI_SM_2026
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation Into the Use of a Motor Imagery-based Brain-computer Interface for Rehabilitation Support in Patients With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT07472556
- Acronym / sponsor ID
- BCI_MI_SM_2026 / BCI_MI_SM_2026
- Conditions
- Multiple Sclerosis
- Keywords
- Brain-Computer interface, Motor imagery, Multiple sclerosis, Neurofeedback, Motor rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pasquale ArpaiaUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback | Experimental | Device: Brain Computer InterfaceParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Computer InterfaceThe 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. | Device | Neurofeedback |
Primary outcome
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).
1 secondary outcome
System Usability and User Acceptance
Time frame: Week 12 (end of treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roberta Lanzillo Lanzillo, Medical Doctor in Neurology contact
Antonio Esposito, PhD Researcher in Engineering contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Computer Interface in people with Multiple Sclerosis, run by Pasquale Arpaia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberta Lanzillo Lanzillo, Medical Doctor in Neurology (+39 081 746 3741, roberta.lanzillo@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modulation of ERD/ERS patterns during Motor Imagery (MI) tasks (time frame: From baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.