Observational Study of the Prevalence of CCSVI in Multiple Sclerosis and in Other Neurodegenerative Diseases
Condition: Multiple Sclerosis; Neurodegenerative Diseases
MeSH terms: Multiple Sclerosis; Neurodegenerative Diseases; Sclerosis
Study type: Observational

Summary: 
      The presence of abnormalities in the cerebral venous circulation, defined as Chronic
      Cerebrospinal Venous Insufficiency (CCSVI), has recently been reported in patients with
      Multiple Sclerosis (MS), in healthy subjects and in subjects with other neurological
      diseases. These reports have aroused much interest both in the scientific world and, above
      all, among the communities of patients and Associations having the aim of aiding people with
      MS and of promoting scientific research into this disease.

      In the literature published so far there is a lack of verification in large samples of the
      prevalence of CCSVI in MS compared with that observed in healthy subjects and in those with
      other diseases of the nervous system.

      This is an observational study investigating the prevalence of CCSVI in subjects with MS and
      comparing it with the prevalence observed in a control population consisting of Healthy
      Controls (HC) and in a population affected by other neurological diseases of the central
      nervous system of degenerative, vascular, inflammatory and autoimmune origin.

      A total of at least 1,200 adults with MS will be included in the study, as well as 400
      healthy subjects and 400 subjects with other neurodegenerative diseases.
    

Detailed description: 
      It has been recently reported the possible presence of abnormalities in the cerebral venous
      circulation of people with MS, in healthy controls and in people with other neurological
      diseases. These reports have aroused much interest both in the scientific world and, above
      all, among the communities of patients and Associations having the aim of aiding people with
      MS and of promoting scientific research into this disease. In particular, the studies by
      Zamboni and colleagues (Ferrara University) and by Zivadinov and colleagues (University of
      Buffalo) have suggested an association between CCSVI and MS that was widely reported by the
      mass media world-wide.

      It can be noted that in the literature published so far there is a lack of verification in
      large samples of the prevalence of CCSVI in MS compared with that observed in healthy
      subjects and in those with other diseases of the nervous system. The recent and authoritative
      contributions from the scientific community involved with MS stressing the need for closely
      controlled and suitably designed clinical studies for investigating the hypotheses suggested
      with regard to CCSVI (with the necessary thoroughness and with the promptness demanded by the
      public opinion) are therefore definitely justified.

      The possibility that there may be a new pathogenic mechanism underlying the development of
      MS, not in line with the majority of the experimental data concerning the aetiopathogenesis
      of this disease, has produced a strong echo throughout the scientific community.
      Increasingly, in recent months, both the working groups mentioned above and new authors have
      developed further research studies in order to confirm and extend the results obtained and to
      lay scientifically sound foundations for possible therapeutic applications for this
      discovery.

      The Fondazione Italiana Sclerosi Multipla (FISM) Onlus, in its capacity as Promoter of this
      study, wishes, responsibly, to produce the best possible answer for people with MS all over
      the world. It therefore feels that it is necessary to proceed with the utmost scientific
      thoroughness, initially by means of a large-scale sample study for evaluating the prevalence
      of venous abnormalities in MS compared with that observed in normal controls and in controls
      with other diseases of the nervous system. In this context, the features of this study that
      distinguish it from previous studies and from the current state of knowledge are the
      following:

        1. Blind multi-Site observational study using the Echo-Color-Doppler equipment assigned to
           the study;

        2. Size of the sample with MS, of at least 1200 study subjects;

        3. Evaluation of the prevalence of CCSVI and of other malformations of the venous
           haemodynamics in the Clinically Isolated Syndrome (CIS), Relapsing-Remitting (RR),
           Primary Progressive (PP) and Secondary Progressive (SP) forms of MS, using a larger
           sample than those involved up to the present time.

      In this observational study, the prevalence of CCSVI and of other malformations of the venous
      haemodynamics will be evaluated in different forms of MS and in other diseases of the nervous
      system. This is therefore an observational study investigating the prevalence of CCSVI in
      subjects with MS and comparing it with the prevalence observed in a control population
      consisting of healthy subjects and in a population of people with other neurological diseases
      of the central and peripheral nervous system of degenerative, vascular, inflammatory and
      autoimmune origin.

      The study is a multi-Site observational study. A total of at least 1,200 adults with MS will
      be included in the study, as well as 400 healthy subjects and 400 subjects with other
      neurodegenerative diseases.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A total of at least 1,200 adults with MS will be included in the study, as well as 400
        healthy subjects and 400 subjects with other neurodegenerative diseases.
      
Keywords: Multiple Sclerosis; Other Neurodegenerative Diseases; Chronic CerebroSpinal Venous Insufficiency; Prevalence; Case-control