NCT04133779

Observational Study on Multiple Sclerosis

Multiple Sclerosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,767 (actual)
• Sponsor: Fondazione Italiana Sclerosi Multipla · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentre observational study which involves 43 of the major Italian centres that treat MS. The duration expected for the study participation of each subject was exclusively the necessary one for the screening visit and execution of the ecocolor-Doppler test, which could have also been executed on the same day.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
PROCEDURE	neurological examination, Kurtzke EDSS, Barthel scale, ecocolor-Doppler	For the subjects diagnosed with MS (group A), who did not need to be in a period of clinical relapse of the disease (at least 30 days from the last clinical relapse), the duration and the form of the disease was indicated (CIS, RR, SP or PP). The Investigator has submitted these subjects to a neurological examination which included the standard neurological examination, the Kurtzke EDSS (Kurtzke Expanded Disability Status Scale) comprising the functional systems of Kurtzke and the Barthel scale. After completing the selection phase following the previous examinations, the subjects were directed towards the qualified practitioner for the ecocolor-Doppler examination which was performed in blind.
PROCEDURE	neurological evaluation, ecocolor-Doppler	For the subjects affected by OND and ONDi, as in the groups C and D respectively, the Investigator has performed, beside the anamnesis and the physical examination, a specific neurological evaluation which included the compilation of the Barthel scale for the disability evaluation. After completing the selection phase following the previous examinations, the subjects were directed towards the qualified practitioner for performing the ecocolor-Doppler examination which was performed in blind.
PROCEDURE	medical history, vital signs, ecocolor-Doppler	For the healthy subjects (HC) of the group B, the Investigator has solely performed the medical history and a check of the vital signs, reporting the demographic and clinical data of the subjects. After completing the selection phase following the previous examinations, the subjects were directed towards the qualified practitioner for the ecocolor-Doppler examination which was performed in blind.

Timeline

• Start date: 2010-12-29
• Primary completion: 2012-05-30
• Completion: 2012-05-30
• First posted: 2019-10-21
• Last updated: 2019-10-21