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Observational Study on Multiple Sclerosis

NCT04133779 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1767

Last updated 2019-10-21

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Fondazione Italiana Sclerosi Multipla

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-29
Primary Completion
2012-05-30
Completion
2012-05-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04133779 on ClinicalTrials.gov