Efficacy and safety of venous angioplasty of the extracranial veins for multiple sclerosis. Brave dreams study (brain venous drainage exploited against multiple sclerosis): study protocol for a randomized controlled trial

Abstract

Background: Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system with a disabling progressive course. Chronic cerebrospinal venous insufficiency (CCSVI) has recently been described as a vascular condition characterized by restricted venous outflow from the brain, mainly due to blockages of the internal jugular and azygos veins. Despite a wide variability among studies, it has been found to be associated with MS. Data from a few small case series suggest possible improvement of the clinical course and quality of life by performing percutaneous balloon angioplasty (PTA) of the stenotic veins. Study design and methods: This is a multicenter, randomized, parallel group, blinded, sham-controlled trial to assess the efficacy and safety of PTA. Participants with relapsing remitting MS or secondary progressive MS and a sonographic diagnosis of CCSVI will be enrolled after providing their informed consent. Each participant will be centrally randomized to receive catheter venography and PTA or catheter venography and sham PTA. Two primary end points with respect to efficacy at 12 months are (1) a combined end point obtained through the integration of five functional indicators, walking, balance, manual dexterity, bladder control, and visual acuity, objectively measured by instruments; and (2) number of new brain lesions measured by T2-weighted MRI sequences. Secondary end points include annual relapse rate, change in Expanded Disability Status Scale score, proportion of patients with zero, one or two, or more than two relapses; fatigue; anxiety and depression; general cognitive state; memory/attention/calculus; impact of bladder incontinence; and adverse events. Six hundred seventy-nine patients will be recruited. The follow-up is scheduled at 12 months. Patients, treating neurologists, trained outcome assessors, and the statistician in charge of data analysis will be masked to the assigned treatment.

MR Venography in Patients with Multiple Sclerosis and Correlation with Clinical and MRI Parameters

“…As limitations, we did not evaluate patients using Doppler sonography but we decided to use MRI since this is the conventional imaging technique to follow‐up MS patients; also MRV has a very good interobserver variability, while Doppler studies to evaluate CCSVI had been frequently criticized by the group of Zamboni et al due to the different technique utilized …”

Multiple Sclerosis in a 23 Years Old Woman Treated by Venous Angioplasty for Chronic Cerebrospinal Venous Insufficiency: A DNA Study by Flow Cytometry

“…The CCSVI syndrome is associated with neurodegenerative disorders. Endovascular therapy appears to be a safe and reliable method for treating CCSVI [10,11]. The high incidence of recurrence of the MS in our case highlights the necessity of the genetic profile analysis in the patients and their first degree relatives.…”

Funding CCSVI research is/was a waste of valuable time, money and intellectual energy: Yes

“…It was suggested that this test was the gold standard for diagnosis of chronic cerebrospinal venous insufficiency (CCSVI) that can be made if at least two criteria are fulfilled. 3 Zamboni and his colleagues found CCSVI in all MS patients they examined, with a sensitivity, specificity, positive and negative predictive value of 100%. No other diagnostic test has ever obtained such positive results.…”