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Monday, March 19, 2012 12:37 AM | CCSVI in MS Toronto Volg link

Approximately 685 patients for the Brave Dreams trial on multiple sclerosis.

 

March 15 2012 - The "brave dreams" by Paolo Zamboni seem destined to come true. Today was officially the start of the Brave Dreams project, a study held in twenty different research centers to test the efficacy and safety of therapy supported by the physician to treat multiple sclerosis.

The Emilia Romagna fully fund the testing, the company and University Hospital of Ferrara will coordinate everything. "They can offer willing to study only patients between 18 and 65 years of age - said Zamboni - with the most common forms of multiple sclerosis: relapsing remitting or secondary progressive, already followed by at least two years by one of the twenty centers involved in the project. "This last parameter was determined because, to tell if the person can be adapted or not the trial, "the neurologist must have the data and the confidence that only the long-standing acquaintance with the patient can provide." They will then professionals involved in research to contact patients.

From an initial selection of subjects - about 685 - it will then pass to the planning of measures to free the extracranial veins - venous angioplasty, the focal point upon which the entire method - which may be real or simulated. "The study that we are making is called double-blind - illustrates Zamboni - because a group of patients will be subjected to therapy and not a group. Only the surgeon will know who was operated on and who was subject to control only phlebography. Both patients and their physicians will be kept in the dark." Only after a year of monitoring data collected will be used to determine if the path indicated to be continued or abandoned.

"We now let the scientists do their job quietly - said Gabriel Rinaldi, director of St. Anne. The hype generated by this research has already taken too much controversy. Brave Dreams has become a brand that no one can use, even for fundraising. The activism of groups of patients in this way should not cause confusion or spread of enthusiasm: the trial is precisely because they are still not enough confirmation of the validity of the method."

The Emilia Romagna is the first institution in Italy supports what he calls "a real scientific endeavor." Continue to monitor the progress of the predetermined path multidisciplinary committee that has already been busy defining its technical design. In May, expected to begin the selection of participants, operators of several centers have in fact already completed the necessary training to start the project. No word yet on which cities will be the first to start the work, also - remember and concludes Zamboni - "so that researchers can engage in an atmosphere as comfortable as possible, and to prevent migration of patients would still not considered given the constraint of two years, will not be made public the names of the participating centers. "

Translated from:

http://www.estense.com/?p=205011