(Reuters) November 26 - The ethics committee of the San Anna hospital in Ferrara (Italy) has approved Prof Zamboni’s randomized double blinded clinical trial to study the diagnosis and treatment of CCSVI, a vascular condition that according to Zamboni is strongly correlated to MS.







The trial has given a go to involve over 500 patients across Italy after the ethics committee gave its approval.





The study includes two phases. An assessment of diagnostic and then a therapeutic assessment of the outcome of the liberation treatment, which involves the unblocking of some veins draining the brain and spinal cord in patients. It is thought that stenosis of blood vessels prevents normal blood flow leading to the 'onset' of CCSVI.









In a recent interview, Zamboni revealed further details about this study. It will involve approximately 15 centres in Italy and double blinded and randomized in order to avoid any residual doubt on the so-called placebo effect. There will be an objective measurement, not just the subjective clinical assessment of a neurologist, but also by using the proper device for measuring motor activity, balance, and neural activity. The study will be completed in two years.









One of the main objectives of the trial is to ascertain whether there is indeed a link between CCSVI and multiple sclerosis. Association which not all specialists agree. In particular, neurologists have expressed some doubt in recent months. According to Zamboni this may be the only study to help us understand the role of CCSVI treatment in MS



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