Clinical Investigation Into the Use of a Motor Imagery-based Brain-computer Interface for Rehabilitation Support in Patients With Multiple Sclerosis.

Not yet recruitingNot a drug-phase studyMS (type not specified)NCT07472556

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Brain Computer Interface

What it measured

Main measures

  • Modulation of ERD/ERS patterns during Motor Imagery (MI) tasks

    From baseline to week 12

    MRI lesionsArm and hand function

Other measures (1)

  • System Usability and User Acceptance

    Week 12 (end of treatment)

    Quality of life (reported by participants)Feasibility

Who could take part

MS (type not specified) · 18 to 60

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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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History

    1. Started

      Jul 2026

    2. Main results due

      Sept 2026

    3. Finished

      Nov 2026

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