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

• Conditions: Multiple Sclerosis

• Registration Number: NCT06219291
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2023-07
• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-07-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Six Minute Walk test (SMWT)	Baseline, Follow-up 1year, Follow-up 2year	Assesses distance in meters walked over 6 minutes as a sub-maximal test of endurance capacity.

Secondary Outcome Measures

Name	Time	Method
Concentration of oxygenated hemoglobin (Delta oxyHb)	Baseline, Follow-up 1year, Follow-up 2year	The differences in oxyHb during task period and resting state. Data will be extracted from functional Near InfraRed Spectroscopy (fNIRS) assessment.
Regularity of gait	Baseline, Follow-up 1year, Follow-up 2yearr	Instrumental gait indexes will be extracted from an Inertial Measurement Unit (IMU) during the a walking test.
Expanded Disability Status Scale (EDSS)	Baseline, Follow up 1year, Follow up 2year	Assess the neurological impairment as a result of Multiple Sclerosis, ranging from 0 (normal neurological exam) to 10 (death due to Multiple Sclerosis).

Trial Locations

Locations (3)

Ospedale Binaghi ASL Cagliari; 🇮🇹 Cagliari, Italy

IRCCS Fondazione Don Carlo Gnocchi; 🇮🇹 Milan, Italy

IRCCS Ospedale San Raffele; 🇮🇹 Milan, Italy