Buffalo Newsletter

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Postby Billmeik » Thu Feb 04, 2010 8:57 pm

I guess we learn more when somebody from Buffalo speaks at the conference in Hamilton tomorrow?
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Postby Billmeik » Thu Feb 04, 2010 8:58 pm

I guess we learn more when somebody from Buffalo speaks at the conference in Hamilton tomorrow?
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Postby MS_Jess » Thu Feb 04, 2010 9:53 pm

sbr487 wrote:The article is full of +ve comments but I just started worrying if the research team has decided to do a course correction after seeing the initial results ... I hope I am wrong ...


Hi sbr487,

I think the newsletter is all very positive. Of course, I don't have answers, but I doubt a course correction is the purpose of Phase II trials. From the research perspective, Phase II implies trying to better understand the results from Phase I. And based on the following quote from the newsletter:

"In preparation, statisticians are at this time working to determine how many subjects are needed for age group, gender, and level of MS progression."

I suspect they are using Phase II to try and determine whether there is any correlation between the varying types of venous malformations and the different types of MS, gender, age, level and type of disability, etc.

To all, I have been watching the forum quietly for about a month now. You are all an amazing, informed group of people and I am so happy to finally join the forum! The information you collectively contribute is truly phenomenal. I can't wait for Buffalo to release the full results of the study!

-Jess
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Postby Jugular » Thu Feb 04, 2010 9:56 pm

Not only does this newsletter strongly hint that CCSVI will be substantially validated when the large scale study results are released mid-February, it hints that they are developing treatments for CCSVI that do not involve angioplasty or stents.

That they are announcing making CCSVI testing generally available beginning when the test results are publically released is highly significant. The testing will include testing for iron deposits (which is something more than what was measured in the Zamboni study) as well as use of a Doppler device designed specifically for testing CCSVI . Not only does this suggests that they have found merit in Zambonis discovery, but they have taken it a step further.

Here are some juicy snippets:

We believe our CCSVI studies
testing Dr. Paolo Zamboni’s
controversial CCSVI theory will
result in groundbreaking discoveries
in the field of MS.

...

I can further tell you that our
research will pose new and provocative
questions about the
CCSVI theory which will be addressed
in the second phase of
the CTEVD Study.

...

BNAC-JNI is
pleased to announce that we will
begin to offer CCSVI Diagnostic
Venous Testing beginning in
mid-February 2010. Patients
may be referred by their neurologists
or be self-referred.

...

A new Doppler machine, specifically developed
for CCSVI, will be used
for all diagnostic procedures.

...

In the
future, we will perform doubleblind
controlled trials using a
treatment that is different from
those used by either Prof. Zamboni
or Prof. Michael Dake of
Stanford University.
...

Together, we are on our way to
discovering about CCSVI. We
continue to believe this research
will be integral to changing the
way MS is defined and treated.


Indeed!
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Postby ErikaSlovakia » Thu Feb 04, 2010 11:48 pm

Extremely good news!!!
Erika
Aug. 7, 09 Doppler Ultras. in Poland, left Jugul. valve problem, RRMS since 1996, now SPMS,
- Nov.3,09: one stent in the left jug. vein in Katowice, Poland, LDN, never on DMDs
- Jan. 19, 11: control venography in Katowice - negative but I feel worse
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Postby eve » Fri Feb 05, 2010 12:15 am

Really really happy about this. Great development. lucky me, I have an appointment with my neuro in 2 weeks. :D
dx 2002,RRMS,  suspected begin of MS 1978 (age 10)
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Postby costumenastional » Fri Feb 05, 2010 12:21 am

Newbie or not MSJess gave us a fantastic present.

MAKE THIS A STICKY PLEASE HAHA.

Eve, i suggest you print this article and feed the papers to your neuro.
It's a total of 5 pages (a4 size). You think he ll be able to digest?
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Postby Algis » Fri Feb 05, 2010 12:51 am

Go Jess Go!! :D
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Postby eve » Fri Feb 05, 2010 1:02 am

Costumenastional - i've been collecting data for weeks now - I think I will walk in with a file larger than he's got on me. :lol:
dx 2002,RRMS,  suspected begin of MS 1978 (age 10)
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Postby NoDrainer » Fri Feb 05, 2010 1:14 am

BNAC CCSVI Newsletter

Buffalo Neuroimaging Analysis Center

Volume 1, Issue 1

A periodic newsletter from the Buffalo Neuroimaging Analysis Center

Letter from the Director

Dr. Robert Zivadinov, MD, PhD
Director, Buffalo Neuroimaging
Analysis Center
February 4, 2010

My Friends,

I write to you today as researchers from the Buffalo Neuoroimaging Analysis Center (BNAC) and the Jacobs Neurological Institute (JNI) at the University at Buffalo are completing their analysis of the first of several studies on chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis (MS). In a few weeks, we will announce the findings of CCSVI prevalence in the first 500 subjects, who participated in the study, Combined Transcranial and Extracranial Venous Doppler (CTEVD) evaluation in MS and related diseases.

We believe our CCSVI studies testing Dr. Paolo Zamboni’s controversial CCSVI theory will result in groundbreaking discoveries in the field of MS. Dr.Zamboni’s theory states that CCSVI is a complex vascular condition characterized by narrowing of the extra-cranial veins that restrict the normal outflow of blood from the brain. This restriction then causes alterations in blood flow patterns within the brain that eventually cause injury to brain tissue and degeneration of neurons.

As many of you are aware, enrollment in the first phase of the CTEVD study was closed in late December. What I can tell you today is that the preliminary results are exciting scientifically and will generate a great deal of discussion among our colleagues, the worldwide press, and individuals like you who are following very closely any developments about CCSVI. We are planning a press release by mid-February, as well as submission of these findings to the American Academy of Neurology annual conference as late breaking news.

I can further tell you that our research will pose new and provocative questions about the CCSVI theory which will be addressed in the second phase of the CTEVD Study. For this next phase, we will include an additional 500 participants who will be examined with a new Doppler machine specifically developed for CCSVI. In preparation, statisticians are at this time working to determine how many subjects are needed for each age group, gender, and level of MS progression. Once we have the numbers, applicants who fit the research profile will be contacted according to the order in which they completed the online questionnaire, and the second phase of screening will begin. When we have confirmed the requisite 500 new participants, we will notify by email the remaining individuals (13,000+) who filled out the online questionnaire with hopes of participating in the study.

As scientists, we are, of course, excited to be engaged in developing a new understanding of MS, a disease that has confounded the medical profession for over 200 years. I speak for the entire BNAC-JNI research team and Dr. Bianca Weinstock-Guttman to let you know that this particular research is having an impact like no other we have known. We have been simultaneously humbled and inspired by the unprecedented volume of requests to participate in the CTEVD study.

At BNAC and JNI, we appreciate the urgency people with MS have exhibited to learn immediately, even before the definitive CCSVI research is complete, whether their veins are constricted.

Therefore, in response to the overwhelming desire they have expressed since learning about the CCSVI theory, we have made a momentous decision. After consulting the Institutional Review Board at the University at Buffalo using preliminary results from the first phase of the CTEVD study that included 500 subjects, BNAC-JNI is pleased to announce that we will begin to offer CCSVI Diagnostic Venous Testing beginning in mid-February 2010. Patients may be referred by their neurologists or be self-referred.

Core testing will include the following:

• 3 Tesla MRI of the brain with quantitative measurement of the level of iron deposits in the brain on susceptibility-weighted imaging, with a report by a neuroradiologist.

• 3 Tesla MRI of the neck aimed at visualization of the jugular, vertebral and other collateral veins, with a report by a neuro-radiologist.

• Doppler exam of the head and neck to acquire images of the direction of venous blood flow in different body positions, with a report by a neuroradiologist.

• Clinical visit that will provide assessment of patient status, discuss the findings and provide a comprehensive summary report with recommendations for the future.

There will also be optional examinations for neuropsychological and rehabilitation assessments, if necessary. Testing for each patient will be done over two days here at Buffalo General Hospital. A new Doppler machine, specifically developed for CCSVI, will be used for all diagnostic procedures.

BNAC-JNI will be the first Center in North America to use such a machine, and will begin to provide training for other Centers that have expressed an interest in mastering the art of CCSVI diagnosis. We wanted to let people know now that they will be able to look to BNAC for comprehensive diagnosis of venous constriction.

Furthermore, we realize that not all MS patients will be able to afford the costs of the diagnostic services in addition to travel to Buffalo. Therefore, we are planning to approach several major insurance providers to request reimbursement approval for these proposed diagnostic tests. Please understand, however, that discussions and negotiations with these companies may take at least 18 months before reimbursements for CCSVI
tests are approved.

BNAC–JNI is proud to be one of the first neurology centers in North America to provide this comprehensive new patient service. We will use the expertise we have developed in our CCSVI research to diagnose venous blockage. With this knowledge, patients and their neurologists will be able to discuss appropriate next steps in their treatment.

Let me now tell you about some other work BNAC is doing in CCSVI. Together with Dr. Zamboni, we are at this time completing the final phases of the EndoVascular Treatment study in MS (EVTMS). We expect preliminary results to be presented by Dr. Zamboni in Florida in early February.

BNAC-JNI has also taken the first step towards treatment of CCSVI. Together with world experts in vascular surgery from the Department of Neurosurgery at the University of Buffalo, we will soon begin the Controlled Randomized EndovaScular Therapy (CRET) study for CCSVI. This will be a 6-month study that will evaluate the safety and preliminary efficacy of therapeutic angioplasty, and will include 30 patients with MS.

In order to avoid any confusion about potential candidates for this study, we will use the same approach as for phase 2 of the CTEVD study: applicants who fill out the newly created CRET questionnaire, fit the research profile and express willingness to undergo endovascular treatment will be contacted according to the order in which they complete the online questionnaire. We will also consider in the selection process those patients who have already sent emails expressing willingness to undergo endovascular treatment.

Positive results from this study will lead to organization of larger clinical trials in MS. In conclusion, I must reemphasize here what I have said many times in interviews over the past year. We cannot recommend endovascular treatment to MS patients before we fully understand the safety of any approach we may propose. In the future, we will perform doubleblind controlled trials using a treatment that is different from those used by either Prof. Zamboni or Prof. Michael Dake of Stanford University. After our initial controlled safety trial concludes, we will test the efficacy of this new procedure on a larger sample of MS patients.

Like you, we want the research to be completed as soon as possible. Only then will it be possible to arrive at a consensus about treatments. We began the first study out of faith that the implications of Dr. Zamboni’s CCSVI theory were so far-reaching that we were impelled to forge ahead with what will be a $5 million study. Working with the University at Buffalo Foundation and the JNI, we have begun our fundraising campaign. In a few days we will submit a request for a major grant to the National Multiple Sclerosis Society in response to their recent call for proposals.

As you will also read in this newsletter, we have had an outpouring of gifts in the past few weeks from people around the world. We are very grateful for this support. To the many people who ask, “When will BNAC be able to say if the CCSVI theory is valid?” we must say that a big part of the answer is, “The sooner we have the funds, the faster we will be able to conclude all the studies we envision.” More about how you can help appears later in this newsletter.

Thank you again to everyone who has been following our research, to those who participated in our first study, to those interested in phase 2 of the CTEVD study, and to everyone who has contributed gifts both large and small.

We understand that everyone with MS hopes for a cure right now. We ask for your patience a little longer to give us time to complete this scientifically valid study. Like you, we look forward to the possibility of a proven and safe endovascular treatment for MS. While we cannot recommend such treatment today, with your understanding and help, we hope we will be able to do so in the future.

Together, we are on our way to discovering about CCSVI. We continue to believe this research will be integral to changing the way MS is defined and treated.

Sincerely,

Robert Zivadinov, MD, PhD
Director
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Postby costumenastional » Fri Feb 05, 2010 1:28 am

Eve, in this case i suggest not to feed him but to hit him with them!!!

Anyway, i doubt he is going to read them.

Just make sure to hit and run if possible!!!!!!
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so amazing

Postby coin » Fri Feb 05, 2010 4:33 am

have been reading the posts and read about tears...yeap fill like that as well and just hope that this appraoch will help as many as possible and even if it helps only some MS patients...cannot wait to read about the official results and then we should storm the hospitals etc here in Germany!!!!!!
let keep our fingers crossed that our hopes and wishes will be fulfilled :D

best from bavaria
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Postby jr5646 » Fri Feb 05, 2010 5:04 am

WOW!!!!!!!!!!!

And just to think... A "housewife" from Southern California's dedication to helping not only her husband, but ALL of us, this would not have occurred.. I sincerely believe that !!


A HUGE THANKS to Joan Beal (Cheerleader) for all of your tireless efforts. Words cannot even begin to describe my elation and I'm sure all of us with MS (and families) are feeling.
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Postby Boreas » Fri Feb 05, 2010 5:10 am

Yeah! All thumbs up for JOAN :!: :!: :!:
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Postby costumenastional » Fri Feb 05, 2010 5:12 am

Respect.
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