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

Don Carlo Gnocchi Onlus Foundation

Status: Invitation-only

Conditions: Multiple Sclerosis

Treatments: Other: Observational

Study type: Observational

Funder types: Other

Identifiers

NCT06219291

03_17/02/2021 Part A

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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