DrSclafani answers some questions

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

Postby drsclafani » Wed Apr 07, 2010 1:35 pm

Why is there so much resistance to ensuring that MS Patients have adequate blood flow in their heads?


you do not have a monopoly on foggy thinking
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Postby CRHInv » Wed Apr 07, 2010 1:47 pm

It would be great to have a tool that would assess brain fog Is there one already? This was one of the most amazing, crazy, borderline miraculous improvements I had almost immediately after my procedure.

If I can ever be of help, I'm in.
dx 4/09 * Stanford appointment 11/09/09 * One stent left, low jugular 11/10/09!<br />One year from treatment, I have my life back.  Placebo schmebo.
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Brain Fog

Postby rettahb » Wed Apr 07, 2010 2:05 pm

Family Elder, I wand to be you!
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Postby drsclafani » Wed Apr 07, 2010 2:08 pm

My question (thinking outloud here) at what point is a procedure considered "non" experimental and / or safe? Is it a certain number? Certain number without complications? what? and why would ins. companies pay for experimental procedures/treatments?


Safe procedures can still be experimental. Dangerous practice can still be standard of care.

The term "research" indicates that an activity is designed to test an idea or hypothesis that enables one to make a conclusion about the idea. For example, the idea that angioplasty with our without stents of jugular and azygous vein stenoses was first researched by Zamboni when he did an open label (non-blinded) study of 65 patients to prove his hypothesis. When one does research, the questions must be stated clearly and the methods used to evaluate objectively the results must be elaborated before the project begins. Research is not done on an individual because statistical confirmation is part of proving the points.

The practice of medicine is different. It refers to treatments that are planned and caried out soley for the benefit of the well being of an individual patient and has a reasonable chance of success. For example, if I use a stent designed for the bile ducts for a narrowing of a vein, that is fine. I am entitled to do it. When we set up a study to determine whether those stents will be adequate in a group of patients and plan to publish those results, then we must design and implement a research project and that project must have oversight.

These ethical standards and guidelines were created in reaction to indescriminant unsafe research projects done during the middle of the 20th Century not only in Nazi German, but also in the United States.

One of the roles of the IRB is to assure that patients' rights are considered when research is done.
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Postby ozarkcanoer » Wed Apr 07, 2010 2:09 pm

Please add to the questionnaire the rating of Pain with a capital P and Fatigue with a capital F. So many people with MS have hidden "subjective" symptoms like pain and fatigue who walk just fine !! Even our highly educated neuros don't seem to understand the impact of chronic fatigue and pain in our lives.

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Postby drsclafani » Wed Apr 07, 2010 2:19 pm

hey Doc,

Research for what? To see if its related to MS, this is a vascular issue. Or research to see if CCSVI can be done on veins? Which I believe ballooning is being done on veins daily around the world. Plus volumes of research has already been done on CCSVI. I am just tired of getting that word research thrown in are faces. Not directed at you. I understand you are just a messenger at this point and your hands are tied.


i am no messenger in this. i am in this with you but do not expect to have hundreds of ccsvi treatment center popping up until doctors are convinced that what we all believe and hope is proven. This is not a TV show that you can cancel in two years.

There are lots of bad medicine, bad techniques, bad results that no one know about. Zamboni reported a small number of patients and almost half had no benefit. half those that did had recurrent stenosis and many of those had recurrent symptoms. He had no complications but i have

So why would you expect all the doctors to jump on this without more data.

I understand and share your frustration. I understand your sense of urgency and sense of futility of all the crappy treatments available. But we are not going to win by sulking. Lets NOT do procedures uncontrolled, where the operators have no obligation to share their data so that we can work out the glitches, enhance the treatments, understand the limitations, avoid the complications. Going to a doc in the box at this early stage is like wasting the knowledge.
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Postby Johnson » Wed Apr 07, 2010 2:21 pm

I would be honored to lead this patient based research project if the group wants. Of course, I would have to run it through the Downstate IRB.

Wouldn't that be a kick in the ass. to have you guys involved in an IRB sanctioned project!


This member of the group would be honoured to have you lead such a project, and to participate. Let's kick some ass.

Dr. Sclafani. I have never encountered a doctor like you. Words fail me, but to say that I wish was your patient.
My name is not really Johnson. MSed up since 1993
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Postby drsclafani » Wed Apr 07, 2010 2:22 pm

why does this "research" even have to mention MS? What's been discovered is a new way to image and treat venous malformations and measure their effects on various functions. A certain set of symptoms seems to indicate that a venogram makes sense, just the same way that thousands of otherwise healthy adults are given catheter procedures because they have "chest pains"


the problem is you cannot separate these narrowings from MS. and we yet do not know which symptoms are ms and which are ccsvi

chest pain is a symptom. what is the symptom of ccsvi that is not part of the symptom complex of ms?
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Postby drsclafani » Wed Apr 07, 2010 2:27 pm

I suppose the big question is how long of a delay is it until the IRB has a chance to look over and (hopefully) approve all of this? Also, and I don't think you can really post this, but if there is a sense that they are likely to approve it and this is just a formality or if there is some true fighting that you will be doing to keep these procedures going.


i believe that our IRB understands the importance of this treatment and will not unduly delay their review. I will soon have a pre-review meeting so that they can understand before reading and have an opportunity to express their concerns and questions so that the official review will not have excessive back and forth.

The role and importance of an IRB is to protect patients from unscrupulous doctors and to assure patient safety, confidentiality and being informed. That the patient records are secure and confidential.

IRBs were started as a response to atrocities in Nazi Germany
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Postby Inge67 » Wed Apr 07, 2010 2:29 pm

Hi all, great idea this tracking record. In fact we are thinking about à similar online tool in the netherlands, but with the potential to make it international.

On a more personal note, i am starting my own tracking. I am due for the procedure in poland on april 27th. I am having fysiotherapy twice a week and my therapist is scoring my physical abilities through standardized tests. She is planning to give me a monthly follow up with the same tests in order to monitor progress.

She would advise everyone who is going to have the procedure to ask their fysio to take these test. So you can objectively measure progress.
For instance she measures balance on a scale, my ability to turn, to transfer from one chair to another., à 2 or 6 minute walking test etc etc.

If you are interested, i can ask the exact names of these tests. I presume that they are internationally accepted.

Hope this helps.

Inge
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Postby drsclafani » Wed Apr 07, 2010 2:33 pm

Wow... an IRB approval appears extremely complicated, labor / time intensive and potentially costly?

Any best and/or worst case guess how long it may take (assuming you are pressing forward with clinical research)? Any chance of getting an exemption? or even Quality of Life trial? Expedited review?


I am hopefull to restart in June.
I will use the time to try to organize more research projects, mobilize the site, and recruit additional neurologists. IT was the amount of patients who could undergo neurological exams that limited our procedures. I amhoping to end up doing more patients by the end of the year than I planned to do this year only a month ago

it is hard to start a train, but harder to stop it
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Postby Cece » Wed Apr 07, 2010 2:34 pm

June is not so far away....
Last edited by Cece on Wed Apr 07, 2010 3:13 pm, edited 1 time in total.
"However, the truth in science ultimately emerges, although sometimes it takes a very long time," Arthur Silverstein, Autoimmunity: A History of the Early Struggle for Recognition
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Postby DizzyLiz » Wed Apr 07, 2010 2:54 pm

Ahmen Dr Sal. What can we do to help?
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Postby markus77 » Wed Apr 07, 2010 2:58 pm

my apologies doc, messenger was the wrong choice of words. what i meant was because they have basically made you put the procedure on hold for the time being you can only answer questions.
STAY REAL MY FRIENDS

dx 1989, spms
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Postby bluesky63 » Wed Apr 07, 2010 3:17 pm

Dr. Sclafani, I see what you mean about having to separate what constitutes an MS symptom vs. a CCSVI symptom. But then I think I am a little confused, because I had an appointment with a local IR, an excellent person, who seemed to indicate that there were already accepted symptoms of a jugular venous stenosis/intracranial hypertension (headaches, visual problems, cognitive problems) that sound like we call MS problems.

And where am I going with this . . . I'm not sure except that I wonder why, if a person presents with this, why wouldn't they be able to go ahead and have a venogram/procedure -- who cares about the MS label?

So I might be answering my own thought here. I guess a person could go ahead and try to get a procedure done wherever they could based on their own unique set of circumstances -- which would be separate from the research that you are setting up in your own hospital. And if there is a centralized tracking database, we all can use it.

I will again make a pitch for the sleepiness scale (I think Dr. Dake used it, or at least a similar fatigue scale).

This is all so surreal. I love it. I said to someone else -- a year ago I had never heard of CCSVI, or Cheerleader, Dr. Sclafani, or any of the wonderful developments. I am so hopeful for the first time in years. I think I can wait a little longer. :-)
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