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

NCT06219291 | Unknown

• 1 other identifier: 03_17/02/2021 Part A
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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

Multiple Sclerosis

Keywords

early phase; non-disabled

Outcome Measures

Primary Outcomes (1)

• Six Minute Walk test (SMWT)

  Assesses distance in meters walked over 6 minutes as a sub-maximal test of endurance capacity.

  Baseline, Follow-up 1year, Follow-up 2year

Secondary Outcomes (3)

• Concentration of oxygenated hemoglobin (Delta oxyHb)

  Baseline, Follow-up 1year, Follow-up 2year

• Expanded Disability Status Scale (EDSS)

  Baseline, Follow up 1year, Follow up 2year

• Regularity of gait

  Baseline, Follow-up 1year, Follow-up 2yearr

Other Outcomes (16)

• Dual Task Cost

  Baseline, Follow-up 1year, Follow-up 2year

• Dual-task Impact on Daily-living Activities Questionnaire (DIDA-Q)

  Baseline, Follow-up 1year, Follow-up 2year

• Timed 25 foot walk (T25FWT)

  Baseline, Follow-up 1year, Follow-up 2year

Interventions

Observational OTHER

Observation of the natural course of the disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited within Persons with Multiple Sclerosis attending the clinical centers for routine medical visits willing to participate to the study after the presentation of the information sheet.

You may qualify if:

• Age \> 17 years
• Stable disease course (without worsening over 1 point at the EDSS in the last 3 months)
• Expanded Disability Status Scale (EDSS) \<2.5

You may not qualify if:

• Major depression
• 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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• IRCCS San Raffaele: collaborator
• Azienda Sanitaria Locale di Cagliari: collaborator

Study Sites (3)

Ospedale Binaghi ASL Cagliari

Cagliari, Italy

Location

IRCCS Ospedale San Raffele

Milan, 20100, Italy

Location

IRCCS Fondazione Don Carlo Gnocchi

Milan, 20148, Italy

Location

Related Publications (1)

• 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.

  PMID: 40382461 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Marco Rovaris, MD

  IRCCS Fondazione Don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

• Raffaella Chieffo, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

• Eleonora Cocco, MD

  Ospedale Binaghi ASL Cagliari, Sardegna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: January 23, 2024
• Study Start: July 1, 2022
• Primary Completion: July 7, 2024
• Study Completion: December 1, 2025
• Last Updated: January 23, 2024

Record last verified: 2023-07

Locations

IT (3)