the National MS Society (U.S.) to Investigate the Relationship of CCSVI to Multiple Sclerosis
Project Title
Principle
Investigator(s) Study Plan
Amount Funded (CDN Unless
Specified) First-Year Progress189 Cerebral Venous MS to help determine whether the veins are abnormal very early in the MS process190
$196,579.14 The team received research ethics board (REB) approval and began enrolling children and teenagers who have MS and healthy controls of the same age. The team’s ultrasound team received training in Dr. Zamboni’s original techniques. The team has created ultrasound and brain imaging procedures suited to explore venous drainage in children.
Determining the patients with MS and healthy controls. In those patients with MS who exhibit signs of abnormalities of vein drainage, the team will explore whether the sites and severity of vein abnormalities correlate with common markers of MS disease activity.191
$199,994.18 The team received REB approval and began recruiting a cross-section of people with MS. The team’s ultrasound technologists have been trained to do scanning as originally done by Dr.
Zamboni and they have refined their scanning protocol. The team upgraded to a new 3 Tesla (3T) MRI scanner, which is twice as strong as standard clinical MRI and expanded their MRI team. The 3T machine went online in March 2011 and is being used to conduct MR venography scans to compare against the ultrasound tests.
Project Title Principle
Investigator(s) Study Plan
Amount Funded (CDN Unless
Specified) First-Year Progress189 Study of CCSVI
To use the ultrasound methods used in Dr. Zamboni’s original study and alternative imaging methods to produce highly detailed images of the head and neck veins in patients with early and later MS, individuals with other neurological conditions and healthy controls. The team will also be measuring the rate at which blood flows in the veins.192
US$586,436 The team received approval of the study from the institutional review board (IRB) and is actively recruiting participants with early and later stages of MS, individuals with other conditions and healthy controls. The team’s ultrasound expert received training in Dr. Zamboni’s original techniques. The team has refined its MR venography protocol and has determined that it will use a relatively new contrast agent or dye. The team has also standardized locations along the length of veins where it takes blood flow measurements.
To use the ultrasound methods used in Dr. Zamboni’s original study, an MRI test that looks specifically at controls. The team will also examine the neck and spinal cord veins obtained via autopsy from people with MS and non-MS controls.193
US$571,261 The team received approval of the study from the IRB and began recruiting and scanning study participants.
The ultrasound team was trained in the techniques originally used by Dr. Zamboni and has standardized the protocol and analysis to achieve consistent results.
The team also developed and standardized techniques for studying autopsy specimens for signs of CCSVI and has gathered autopsy specimens of venous tissue from nine MS tissue donors and six donors who did not have MS. The team is analyzing the data and has submitted abstracts reporting preliminary findings anatomy of veins in the neck, chest and spine and to assess for iron deposits in the brain.
The team will also measure levels of iron in the brain in those with and without vein blockages.194
$102,866 The team obtained REB approval and has been conducting the first phase of scanning, using MRI and MR venography, in people without MS. Team members have been trained in the ultrasound techniques originally used by Dr. Zamboni.
Project Title Principle
Investigator(s) Study Plan
Amount Funded (CDN Unless
Specified) First-Year Progress189 Investigation with MS and controls without MS, using catheter venography, Doppler ultrasound (such as what was originally done by Dr. Zamboni to identify CCSVI) and magnetic resonance studies of the veins. The study will include family members, such as identical twins of MS patients who have not developed MS, in the control group.195
$200,000 Both study sites received REB approval and the ultrasound technologists were trained by Dr. Zamboni. The sites have had two rounds of recruitment and scanned “a significant number of participants.” Radiologists at both sites met to ensure the consistency of their protocols.
It is anticipated that all testing will be completed by the end of 2011. in individuals with all major clinical types of MS and people in various non-MS control groups. The team will also study whether the ultrasound findings can be confirmed by other non-invasive imaging techniques to determine the most reliable method to screen for CCSVI.196
US$574,958 The team received IRB approval and began recruiting participants. The team’s neurosonographer received intensive training for intracranial and extracranial ultrasound scanning techniques. The team has
“scanned a significant number of participants”;
however the team has encountered difficulty in recruiting non-MS control subjects and study participants becoming ineligible to continue after receiving the venoplasty procedure outside the bounds of the study.
Source
See references cited in the table.