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Preventing the Progression of Multiple Sclerosis: Early Rehabilitative Treatment and Multimodal Assessment - Part A

NCT06219291 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-01-23

No results posted yet for this study

Summary

Motor performance of people with Multiple Sclerosis (PwMS) can decline since the onset of the disease.

Longitudinal studies are needed to detect early worsening in mobility and balance using wearable devices for activity tracking and neurophysiological techniques for investigating brain functional adaptation. Similarly, neurophysiological assessment can provide evidences on the integrity of brain motor networks and mechanisms underlying cortical plasticity in the early disease phase, potentially providing a set of reliable prognostic factors of disease progression in early diagnosed PwMS.

Furthermore, disease progression might be delayed using physical activity, which is effective in PwMS with moderate disability to ameliorate mobility and promoting brain reorganization and seems promising also for PwMS in the early stages of the disease. Functional Near-Infrared Spectroscopy (fNIRS) measures blood flow which accompanies neuronal activity, thus, it can provide spatial information about changes in cortical activation patterns and it could represent a useful tool for studying the effect of exercise on cortical plasticity. The aims of the study in non-disabled PwMS are: 1) a) to assess the presence of subclinical balance and walking impairments using wearable devices and multimodal gait analysis and b) to investigate cortical activity during exercise, 2) to define prognostic factors associated to disease progression and 3) to study the efficacy of physical activity in preventing the worsening of mobility and stimulating brain functional adaptation.

Conditions

Interventions

OTHER

Observational

Observation of the natural course of the disease

Sponsors & Collaborators

  • IRCCS San Raffaele

    collaborator OTHER

  • Azienda Sanitaria Locale di Cagliari

    collaborator OTHER

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Principal Investigators

  • Marco Rovaris, MD · IRCCS Fondazione Don Carlo Gnocchi

  • Raffaella Chieffo, MD · IRCCS Ospedale San Raffaele

  • Eleonora Cocco, MD · Ospedale Binaghi ASL Cagliari, Sardegna

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2024-07-07
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06219291 on ClinicalTrials.gov