From Dr. Zamboni on new published research

August 12, 2011 at 1:22pm

An important message from Dr. Zamboni regarding the newly published study placed online today.  This is the 2nd  CCSVI endovascular treatment study undertaken in Ferrara, Italy.  The patients were Italian and American, in cooperation with BNAC.   There were two groups, an immediate treatment group, and a delayed treatment group,  The MRI technicians were blinded as to who was in which group.  All patients were on disease modifying drugs before, during and after, for consistancy in treatment.   This is very important to understand.  Angioplasty for CCSVI reduced lesions, improved MS symtoms and reduced relapses, when compared to those in the delayed group on the drugs alone.  Here's the note from Dr. Zamboni-

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Here attached for you, from the site of the European Journal of Vascular Endovascular Surgery, the second treatment study.  This study is also known as MS-EVT treatment of American and Italian patients who have traveled from across the Atlantic to be treated.
http://www.ejves.com/article/S1078-5884%2811%2900201-2/abstract

The study design is unique in the history of medicine. The patients were operated on in Ferrara, but the results were audited in Buffalo. Patients were divided into two mixed groups of Italians and Americans. The first ITG  (immediate treatment group) was operated on immediately, while the second group DTG (delayed treatment group) was treated six months later, allowing us to compare the ITG with DTG. Finally, we compared patients in the second six months, when both groups were operated on.  Then, all patients were compared with their original state during the previous year, prior to PTA.

The study is small (we had no money to do more), however, is very strong, certainly stronger than that of 2009 JVS, as it eliminates many of the criticisms of the latter. Particularly--

1. There is a control group for comparison, in practice it as a randomized as possible for use in surgery

2. MRI measures are rigorous, high-standard 3-tesla, comparable and indisputable as completely blind

3. Patients were evaluated by neurologists and neuroradiologists of two centers

4. Statistical analysis was done by an independent statisticians and blinded.

What does it prove

1. Both groups after the PTA had a significant improvement in the MSFC score compared to previous year, with substantial maintenance of EDSS (no disease progression)

2. In the ITG during the first 6 months there were fewer relapses. The percentage has been on an annual basis of 0.16 against 0.66 of the DTG. In fact the DTG in the first six months received only drugs. After surgery, the DTG no longer had more relapses than the ITG, confirming the protective effect of PTA on relapses.

3. ITG  T2 lesion load decreased while the DTG increased. After the PTA in the DTG lesion load stabilized during the second six months.

4. Complications were zero, zero thrombosis

5. 27% restenosis

6. ITG had one patient- despite the PTA, who had a recurrence and worsening on the MRI, confirming that the MS-CCSVI can not be handled alone by only interventionist. This article suggests the causes of deterioration after PTA on which new studies are needed.

More results

1. Ahead Zivadinov and all 17 consecutive patients had venography confirmed CCSVI

2. the ITG had an effect more pronounced in brain volume reduction than that of the DTG, a likely anti-edema and anti-inflammatory effect of the PTA.

Key messages

* CCSVI is associated with MS --as the first treatment of the condition changes the clinical parameters of the second

* The modification of parameters in a blinded MRI is totally immune from the placebo effect, then measured the improvements are real

* The treatment is safe in safe hands and can be beneficial

* To say after these two pilot studies, positive treatment studies, epidemiological studies have to wait is not sustainable

Paolo Zamboni, MD

Director, Vascular Diseases Center

University of Ferrara

 Fasudil, cerebral blood flow and Michael J. Fox

July 31, 2011 at 1:36pm

In the news today, Michael J. Fox's foundation for Parkinson's research has awarded a grant to study a relatively new drug that improves cerebral blood flow after ischemic injury.  What is interesting is that this drug is also being studied as a treatment for MS.  This is the kind of drug that makes sense; one that helps after axonal death due to ischemia.   Let's also hope that CCSVI and the International Society for Neurovascular Disease research provides more answers for those with Parkinson's.

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GRAND RAPIDS -- Actor Michael J. Fox's foundation for Parkinson's research has awarded a $400,000 grant to fund research by Grand Rapids scientists into a drug that has the potential to halt the progression of the disease.

The focus of their efforts is Fasudil, a drug already approved in Japan to improve blood flow to the brain in stroke victims. It has shown similar positive outcomes in the U.S. in late-stage clinical trials.

Fasudil also showed potential for improving learning and memory and reducing the risk of Alzheimer's in a 2009 study by TGen and Arizona State University. VARI investigators discovered its potential for treating Parkinson's while testing drugs to reduce the toxicity caused by a gene implicated in Parkinson's disease.

"Fasudil has a very favorable safety profile in humans and is already available in Japan as an oral tablet, so upon successful milestone completion, we could be seeing clinical trials within two to three years," MacKeigan said in a statement.

http://news.msu.edu/story/9622/

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The reason it is also news for those of us in CCSVI, is because of Fasudil's affect on the endothelium, cerebral blood flow and nitric oxide.  This compound could be very helpful in recovery from brain and spinal cord injury due to CCSVI.   Here are some more studies on this drug:

Dr. Fox's and Cleveland Clinic CCSVI study update

July 14, 2011 at 1:52pm

The one year update from the National MS Society on the CCSVI studies did not supply any real hard data. It appears most of the teams are waiting for the 2 year mark to unveil their results.  This is disappointing, because the clock keeps ticking for those who have venous malformations and obstructions.

Dr. Fox's CCSVI study report caught my eye, since I've mentioned CCSVI and the effects of hydration many times on here, especially in relationship to hypovolemia, or low blood flow due to dehydration.

Here is the post where I mentioned the importance of hydration and blood flow.   Highly recommended reading:

http://ccsviinms.blogspot.com/2010/12/blood-flow-and-ccsvi-december-26-2010.html

I found it interesting that Dr. Fox's team is exploring hydration in relationship to CCSVI---and wondering if he will use hypovolemia as an explanation for CCSVI.

.....the state of hydration of the subject (whether they drank adequate amounts of fluids) could impact results of several of the criteria used to determine CCSVI. They concluded that these complications may help explain the mixed results reported thus far related to CCSVI and MS, and they have added to their aims a study designed to evaluate the impact of hydration on CCSVI assessments.

The reason this is important is that we know not everyone who has CCSVI is dehydrated.  My husband always drank adequate fluids, and he had two severely deformed jugular veins.  But adequate hydration IS essential for good bloodflow.

I also found another aspect of Dr. Fox's study interesting, in that Dr. Gabbiani has studied biopsies of internal jugular veins taken from living people with CCSVI, and found a collagen shift in the jugular vein tissue.  Wondering what Dr. Fox's team will find from autopsy tissue.  Looks like we'll find out in October 2011--which is sooner than the 2 year mark.

Dr. Fox’s team has also gathered autopsy specimens of venous tissue from 9 MS tissue donors and 6 donors who did not have MS. The team first had to develop and standardize techniques for studying these specimens for signs of CCSVI. They are analyzing their data and have submitted abstracts reporting preliminary findings related to this pathology study and their scanning results for consideration at the international ECTRIMS (European Committee for Treatment and Research in MS) meeting in October 2011. 

I'm going to be a glass half full gal today, and say that I am hopeful for these studies and all that we can learn to help pwMS and pwCCSVI.

Joan