Italian multicentre observational study of the prevalence of CCSVI in multiple sclerosis (CoSMo study): rationale, design, and methodology

Abstract

Chronic cerebro-spinal venous insufficiency (CCSVI) has been proposed as a “congenital malformation” implicated in the pathogenesis of multiple sclerosis (MS). However, numerous studies failed to confirm its presence in MS patients. This paper presents the rationale, design, and methodology adopted in the CoSMo study, conducted with the aim of verifying whether or not CCSVI is linked to MS. The primary endpoint of the CoSMo study is to compare the prevalence of CCSVI in patients with MS versus patients affected by other neurodegenerative diseases (OND) and healthy volunteers. CoSMo is a multicenter, blinded, prevalence study recruiting 2,000 adult subjects, involving 43 MS centers across Italy. Assessment of the presence or absence of CCSVI is performed by color-coded duplex (CCD) sonography and two out of the five criteria according to Zamboni are necessary for the diagnosis of CCSVI. Local CCD examination carried out by a certified sonologist and the central image readings performed by experts in the field are blinded. An advanced protocol is also described in this paper. The application of a rigorous methodological design will definitively confirm whether an association exists between CCSVI and MS. Should an association be observed, this study also further examines the link between CCSVI and the severity of MS. The addition of subgroups without MS and OND also provides information on whether CCSVI is specific to MS only. Results from the CoSMo study will play a crucial role in the possible studies concerning the potential treatment of CCSVI in MS.

Observational case-control study of the prevalence of chronic cerebrospinal venous insufficiency in multiple sclerosis: results from the CoSMo study

“…The rationale, study design and methodology were recently published. 30 The primary objective of the CoSMo study, named after the Italian words ''CCSVI: Studio Osservazionale Sclerosi Multipla e OND,'' which translates to Observational Study of the prevalence of CCSVI in multiple sclerosis and OND, is to compare the prevalence of CCSVI in MS patients, healthy controls (HCs) and patients with other neurological diseases (ONDs). The secondary objectives are the evaluation of the correlation of CCSVI with demographic and clinical parameters.…”

Internal Jugular Vein and Multiple Sclerosis Story

“…Comi et al [7] published the results of their "Italian multicenter observational study of the prevalence of CCSVI in multiple sclerosis" (CoSMo study) which attempted to validate the presence of CCSVI in MS using Zamboni's DU criteria. He CoSMo group found that in MS patients, the presence of CCSVI was 3.26%.…”

A Swan Song for CCSVI

“…There are now two recent publications of good and unbiased quality, studying approximately 2000 patients, that show that CCSVI has no higher prevalence in MS than in any other group of patients without MS or healthy volunteers, which proves the hypothesis of CCSVI and venous congestion in relation to MS to be wrong [2,3]. Next to the five Zamboni criteria, many followers were encouraged by the observation that some MS patients responded positively to the balloon dilatation treatment.…”

“…Others have been less cautious, focusing instead more on the perceived opportunities of this new technique. Now that two major studies [2,3] have shown that CCSVI does not exist-not in MS and not in any other group, such as siblings of MS patients and healthy volunteers-it is perhaps time to draw some conclusions regarding the introduction of future new and socalled promising interventional procedures.…”