by FACEBOOK - CCSVI in Multiple Sclerosis - January 15, 2011 |
The Ethics Committee of Ferrara has approved the experimental protocol of randomized controlled trials to evaluate clinical efficacy and safety of the intervention of unblocking the extracranial veins in patients with multiple sclerosis and diagnosis of "chronic cerebrospinal venous insufficiency (CCSVI ) called BRAVE DREAMS.
The study includes a comparison of surgery versus phlebography with venous angioplasty. a control treatment that is only performed phlebography. Eligible patients are aged 18-65 years, with MS defined according to the criteria of McDonald's and with a confirmed diagnosis of CCSVI.
The study has two primary endpoints:
a) clinical (improvement / stability / deterioration in a synthetic functional endpoint) at 12 months
b) MRI (active lesions at 12 months).
The study is intended as a multi-center, with availability in the centers of clinical skills and equipment needed in order to participate in the study. It is expected to recruit about 550 patients. The duration of the planned follow-up is 12 months. Evaluations concerning the follow-up will be conducted in a blinded fashion.
List of centers that sent the request to join the study for experimental angioplasty in patients with MS and CCSVI (study BRAVE DREAMS)
A committee will evaluate the credentials of these centers in making this site known as the Centres have completed the training phase and become operational for the selection of patients who want to join.
