Clinical trial NCT06219291: Preventing the Progression of Multiple Sclerosis: Early Rehabilitative Treatment and Multimodal Assessment - Part A
Official title: Preventing the Progression of Physical Disability and Promoting Brain Functional Adaptation in People With Multiple Sclerosis: Integration of Early Rehabilitative Treatment and Multimodal Clinical and Instrumental Assessment - Part A
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Multiple Sclerosis
Keywords: early phase
non-disabled
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: IRCCS San Raffaele
name: Azienda Sanitaria Locale di Cagliari
First posted: 2024-01-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Six Minute Walk test (SMWT)
timeFrame: Baseline, Follow-up 1year, Follow-up 2year
Secondary outcomes:
measure: Concentration of oxygenated hemoglobin (Delta oxyHb)
timeFrame: Baseline, Follow-up 1year, Follow-up 2year
measure: Expanded Disability Status Scale (EDSS)
timeFrame: Baseline, Follow up 1year, Follow up 2year
measure: Regularity of gait
timeFrame: Baseline, Follow-up 1year, Follow-up 2yearr
Other outcomes:
measure: Dual Task Cost
timeFrame: Baseline, Follow-up 1year, Follow-up 2year
measure: Dual-task Impact on Daily-living Activities Questionnaire (DIDA-Q)
timeFrame: Baseline, Follow-up 1year, Follow-up 2year
measure: Timed 25 foot walk (T25FWT)
timeFrame: Baseline, Follow-up 1year, Follow-up 2year
measure: Fullerton Advanced Balance Scale - Short version (FAB-s)
timeFrame: Baseline, Follow-up 1year, Follow-up 2year
measure: Explosive power
timeFrame: Baseline, Follow-up 1year, Follow-up 2year
measure: Tactile sensitivity (Monofilament Test)
timeFrame: Baseline, Follow-up 1year, Follow-up 2year
measure: Nine Hole peg Test (NHPT)
timeFrame: Baseline, Follow-up 1year, Follow-up 2year
measure: The revised Brief Visuospatial Memory Test (BVMTR):
timeFrame: Baseline, Follow-up 1year, Follow-up 2year
measure: California Verbal Learning Test (CVLT2):
timeFrame: Baseline, Follow-up 1year, Follow-up 2year
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline, Follow-up 1year, Follow-up 2year
measure: Multiple Sclerosis Walking Scale 12 (MSWS-12)
timeFrame: Baseline, Follow-up 1year, Follow-up 2year
measure: Fatigue Severity Scale (FSS)
timeFrame: Baseline, Follow-up 1year, Follow-up 2year
measure: Community Integration Questionnaire (CIQ)
timeFrame: Baseline, Follow-up 1year, Follow-up 2year
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, Follow-up 1year, Follow-up 2year
measure: Lifetime Total Physical Activity Questionnaire (LTPAQ)
timeFrame: Baseline, Follow-up 1year, Follow-up 2year
measure: Amount of physical activity
timeFrame: Baseline, Follow-up 1year, Follow-up 2year
Locations:
city: Cagliari
country: Italy
facility: Ospedale Binaghi ASL Cagliari
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffele
city: Milan
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi
Study officials:
affiliation: IRCCS Fondazione Don Carlo Gnocchi
name: Marco Rovaris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Ospedale San Raffaele
name: Raffaella Chieffo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Binaghi ASL Cagliari, Sardegna
name: Eleonora Cocco, MD
role: PRINCIPAL_INVESTIGATOR
References: