It was good to hear and see these two, and their conversation was wonderful. Sharon has become a well-versed advocate for those with MS. The fact that she has MS and understands all of the medical terminology and scientific talk-- and takes it upon herself to travel and document this research--is so helpful for all of the laypeople around the world who wish to understand more about CCSVI research. Thank you, Sharon!!! You are a dynamo and we all appreciate you!!! Thanks also to Florence D'Eon for all of her technological and photographic support. She also has MS and travels on her own to document the science. Thank you!!
The Brave Dreams trial is a scientifically robust, double-blinded, placebo controlled trial. It is currently embargoed--meaning we will not know specific results until it is published in a peer-reviewed journal. Because it is an interdisciplinary study involving neurologists, interventionalists, vascular and imaging specialists, it is going to take a lot of work to get the results vetted by all, and written up in a manuscript everyone agrees to. Dr. Zamboni stressed that this is essential, in order to have the science taken seriously and published.
What we do know--this was a six center study throughout Italy. 200 subjects started the year long study, 125 people completed it. They were mostly RRMS and some SPMS (under 5.5 EDSS) who were investigated, treated (or not if they were in the sham control) and followed a year through completion of this study. There were primary endpoints, which Dr. Zamboni explained were OBJECTIVE. This means that these changes were not subjective, or based on patient's feelings, but were measurable by approved medical instrumentation. These objective measurements included volume of bladder, visual acuity, timed walking and manual dexterity, as well as MRI lesion consideration. All of these measurements were looked and compared during 3, 6, 9, and year intervals. The first paper will report on these primary endpoints after treatment, and will hopefully be available next June.
As Dr. Zamboni stressed---this type of trial is unique and should become the gold standard for MS treatments. NO drug trial has ever been weighted and measured in such a precise, objective way.
To the patients, Dr. Zamboni asked us all to "be patient". There will be more coming on how CCSVI treatment improves perfusion and cerebrospinal flow, as well as how it helps with depression, memory, fatigue, and cognition. This research is more "like an opera"--it is going to take cross-disciplinary collaboration and cooperation. Across disciplines and countries.
For those who are out of wait---this news is frustrating. For many of us, the time it is taking to gain scientific acceptance is far too long. And as many have stated--how can having slowed venous drainage be good for the brain? Shouldn't CCSVI be repaired?
There are other CCSVI treatment trials happening now or planned for the future at Alfred Hospital in Australia, in Canada, and through the ISNVD. As to the comment that CCSVI science is "dead"-- many scientists agree that the study is just beginning. To claim that vascular MS research is over, simply because this is taking time and hard work, is absurd.
The 2017 ISNVD conference will be in Taormina, Italy in May. It will focus on the microbleeds and inflammation in the brain, neurodegenrative disease, stroke, the heart brain connection and vascular interventions. It will bring together international imaging specialists, neurologists and vascular specialists. This will be a meeting of hearts and brains. Patients, caregivers and laypeople are invited to attend.
link to ISNVD 2017
Onward,
Joan
