Dr. Zamboni, the man who pioneered CCSVI treatment for multiple sclerosis, is set to launch a new study in July 2011. He identified the purpose of this study:
“To assess in a double blinded randomized control trial (RCT) study design safety and effectiveness of balloon angioplasty of the main extracranial and extravertebral veins in multiple sclerosis (MS) associated to chronic cerebrospinal venous insufficiency (CCSVI).”
Since his last study medical professionals have pointed out the necessity of such a trial and the Canadian government has also been asserting the need for CCSVI treatment to be proven safe.
There will be 679 patients taking part, with half being given a fake CCSVI procedure.
Every three months the patients will be monitored very carefully for dynamic and static balance, walking, manual dexterity, sphincter control and vision. They will undergo MRI scans and Doppler ultrasounds. Chronic fatigue, cognitive function, memory, emotional status, bladder problems and relapse rate are also to be examined.
The inclusion criteria was also identified:
•patients that have CCSVI associated with MS
•relapsing-remitting and\or secondary progressive
•18-65 years of age
•disease duration of under 10y
•No relapse in the 30 days before the procedure
•clinical stability over the last 6 months
•Patients having the best available therapy
Ken Torbert, founder of CCSVI Locator, wrote on ccsvi.nl that he believes the inclusion criteria is quite narrow and that even if Zamboni sees strong results for CCSVI treatment, governments will only want to make it available to people who fit the criteria he used.
Read the full article on CCSVI.nl
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