Preventing the Progression of Multiple Sclerosis: Early Rehabilitative Treatment and Multimodal Assessment - Part A
NCT ID: NCT06219291
Last Updated: 2024-01-23
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
80 participants
OBSERVATIONAL
2022-07-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Observational
Observation of the natural course of the disease
Eligibility Criteria
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Inclusion Criteria
* Stable disease course (without worsening over 1 point at the EDSS in the last 3 months)
* Expanded Disability Status Scale (EDSS) \<2.5
Exclusion Criteria
* Mini-Mental State Examination \< 27
* Other cardiovascular or orthopedic diseases that interfere with physical exercise
* Undefined or not confirmed diagnosis of MS (Polman criteria)
* Progressive course of the disease
18 Years
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
Azienda Sanitaria Locale di Cagliari
OTHER
Fondazione Don Carlo Gnocchi Onlus
OTHER
Responsible Party
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Principal Investigators
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Marco Rovaris, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Fondazione Don Carlo Gnocchi
Raffaella Chieffo, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Ospedale San Raffaele
Eleonora Cocco, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale Binaghi ASL Cagliari, Sardegna
Locations
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Ospedale Binaghi ASL Cagliari
Cagliari, , Italy
IRCCS Ospedale San Raffele
Milan, , Italy
IRCCS Fondazione Don Carlo Gnocchi
Milan, , Italy
Countries
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References
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Gervasoni E, Torchio A, Bertoni R, Chieffo R, Rocca MA, Pau M, Cocco E, Morozumi T, Filippi M, Cattaneo D, Rovaris M. Beyond EDSS: multidomain impairments are detectable and associated with walking disorders in low-disabled people with multiple sclerosis. J Neurol. 2025 May 18;272(6):404. doi: 10.1007/s00415-025-13128-7.
Other Identifiers
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03_17/02/2021 Part A
Identifier Type: -
Identifier Source: org_study_id
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