BRAVE DREAMS (abbreviation of BRA.VE DR.E.A.M.S.), is for BRAin VEnous DRainage Exploited Against Multiple Sclerosis. It is the name of the clinical study to evaluate the efficacy and safety of the intervention of unblocking the extra-cranial veins in patients with multiple sclerosis diagnosed with "Chronic Cerebro-Spinal Venous Insufficiency (CCSVI)”.
The trial is sponsored by the University Hospital of Ferrara where Professor Paolo Zamboni is the principal researcher.
On November, 28th 2010 the trial protocol was approved by the Ethical Committee of Ferrara. About 20 institutes in Italy asked to participate at the study; at present their credentials are under evaluation by a special committee.
BRAVE DREAMS is multicenter double-blind trial that is expected to recruit 679 patients. It will compare the outcomes of an intervention of phlebography including venous angioplasty, with the outcomes of a simple phlebography without angioplasty.
The primary objective of this study is the measurement of physical and cognitive conditions in order to evaluate if the unblocking intervention can slow down or prevent their deterioration and consequently prevent disabilities. The physical functions (balance, vision, ambulation, sphincter functions) will be measured by diagnostic instruments that are objective and not only by a subjective neurological evaluation. The trial will involve patients aged between 18 and 65 years- diagnosed with multiple sclerosis according to McDonald’s criteria1 and with a confirmed diagnosis of CCSVI. A reservation list will not be open to participate at the study: as typically happens in the trials, the subjects will be recruited directly from neurological centers involved in the trial.
For more information:
University Hospital of Ferrara:
The Trial costs
The General Director of the University Hospital of Ferrara - Dr. Gabriele Rinaldi – declared that each one of the patients admitted to the testing phase will cost € 3,368 (about US$ 4’600). Additional costs will comprise the centralized reading of MRIs, journey and accommodation, and other organizational costs; total cost of the trial arrives to 2.5 millions of euro. At present the certain contributions of Hilarescere Foundation, and Emilia Romagna Region, are estimated to be respectively € 200 thousand and € 180 thousand. The sustainment of some direct costs (MRI, ultrasound, etc.) could increase the resources available to € 600-700 thousand. Nevertheless, the current funds guarantee less than the 30% of total cost.
Synopsis, diagram and flowchart of the study BRAVE DREAMS
BRAVE DREAMS is a randomized controlled trial to evaluate clinical efficacy and safety of the intervention of unblocking the extra-cranial veins in patients with multiple sclerosis and diagnosis of "chronic cerebrospinal venous insufficiency” (CCSVI). The study includes a comparison of a phlebography without intervention with venous angioplasty.
Eligible patients are aged 18-65 years, diagnosed with Multiple Sclerosis according to McDonald's critera and with a confirmed CCSVI diagnosis.
The study has two primary endpoints:
- clinical (improvement / stability / deterioration in a synthetic functional endpoint) at 12 months
- MRI (active lesions at 12 months).
The study is intended as a multi-center one, according to the availability of technical skills and instruments of the institutes that will apply for the study. It is expected to recruit 567 patients. The duration of the follow-up is 12 months. The follow-up evaluations will be performed in a blinded way.
1 McDonald WI, Compston A, Edan G, et al. (2001). "Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis ". Ann. Neurol. 50 (1): 121–7. doi:10.1002/ana.1032. PMID 11456302.
Polman CH, Reingold SC, Edan G, et al. (2005). "Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria"". Ann. Neurol. 58 (6): 840–6. doi:10.1002/ana.20703. PMID 16283615.