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Sponsor: Fondazione Don Carlo Gnocchi ETS
Conditions: Multiple Sclerosis, Relapsing-Remitting
Interventions: personalized combined physical and cognitive intervention
Countries: Italy
Our project proposal is based on an individualized rehabilitation approach in patients with early stage relapsing remission (RR) MS. This approach will be based on risk stratification obtained using several clinical and demographic parameters that are not commonly used in clinical practice. This risk score will be obtained from an extensive neuropsychological, psychosocial and physical assessment to which patients will undergo at baseline and at one-year follow-up.The risk score will allow a better stratification of patients' risk of disease worsening/progression and the application of a preventive and personalized strategy.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * diagnosis of RRMS based on the 2017 McDonald criteria; * age ≥ 18 years; * EDSS ≤ 2.0; * disease duration ≤ 5 years; * verification of MS subtype, * duration of disease and EDSS will be accomplished by obtaining a signed consent form for the release of medical information from the treating neurologist. Exclusion Criteria: * history of relevant psychiatric comorbidities. * Severely depressed subjects assessed through the Beck Depression Inventory (scores ≥ 29); * relapses or corticosteroid treatment in the 30 days before inclusion; * history of substance abuse; * presence of non-MS related physical or cognitive impairment that could make the patient unable to complete the study assessments.
- Florence, Italy