Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 10:53 AM
Study NCT ID:
NCT07472556
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Motor Imagery-based Brain-computer Interface With Multiple Sclerosis Patients.
Sponsor:
Pasquale Arpaia
Organization:
Study Overview
Official Title:
Clinical Investigation Into the Use of a Motor Imagery-based Brain-computer Interface for Rehabilitation Support in Patients With Multiple Sclerosis.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BCI_MI_SM_2026
Brief 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). 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).
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: