Status:
COMPLETED
Resilience in Young Adults Newly Diagnosed With Multiple Sclerosis
Lead Sponsor:
Universita di Verona
Collaborating Sponsors:
Azienda Ospedaliera Universitaria Integrata Verona
Fondazione Italiana Sclerosi Multipla
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-45 years
Brief Summary
This study aims to fill the gap of knowledge on the biopsychosocial (BPS) characteristics and resilience of young adults newly diagnosed with Multiple Sclerosis, to evaluate the relationship among the...
Detailed Description
Multiple sclerosis (MS) is the most common neurological disease causing disability in young adults and is widely recognized as a major stress factor. Several studies have shown that the first years af...
Eligibility Criteria
Inclusion
- MS diagnosis in the 2 years prior to study inclusion, according to the revised McDonald Criteria (Thompson et al., 2018);
- MRI of the brain in the 6 months prior to or within one month after screening visit according to a standardized protocol (including pre- and post-contrast volumetric T1-weighted, 3D Fluid Attenuated Inversion Recovery (FLAIR), and 3D Double Inversion Recovery (DIR) sequences for brain imaging, and sagittal and axial pre- and post-contrast volumetric T1-weighted, T2-weighted and short tau inversion recovery (STIR) sequences for spinal cord imaging)
- Italian speakers.
Exclusion
- Clinically relevant cognitive deficits as evaluated by the treating neurologist
- Treatment with any disease-modifying therapy (DMT) for MS at inclusion and by completion of study procedures (maximum two months from consent); steroids administration up to 30 days prior to inclusion is allowed.
Key Trial Info
Start Date :
February 26 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03825055
Start Date
February 26 2019
End Date
March 31 2022
Last Update
November 15 2022
Active Locations (1)
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1
Azienda Ospedaliera Universitaria Integrata Verona, Policlinico G.B. Rossi
Verona, Veneto, Italy, 37134