The first national CCSVI treatment study is approved

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

Postby nicknewf » Wed Sep 01, 2010 7:54 pm

So upset about the CanGov back down after their meetings with the MSSC "experts" that I missed the Albany Study gettign the go ahead. Sweet!

(Anyone know the rules on unblinding the study?)
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Postby Cece » Wed Sep 01, 2010 9:27 pm

MegansMom wrote:I guess this is good news, but hey, I wouldn't want to be one of the sham procedure patients.

I guess its good if you don't have health insurance because they sure will have to be covering the procedure cost. But asking people to get a venogram twice is a lot to ask.

If I had the anomaly I would want it fixed pronto! Afterall we are talking about potential Brain damage and MS progression without venous impairment repair.

Bravo to those brave enough to join this study!

I agree with much of this. Having a venogram twice wouldn't bother me particularly; heck, this is what Dr. Mehta is doing already with his conservative treatment of one jugular done per procedure. But there will be a year of no treatment in between those two venograms, for those in the sham group.

Still I want to choose my words carefully because I support Dr. Mehta's trial. There is an opportunity here, I think, if you are near Albany but without insurance; if you are not entirely convinced about CCSVI's merits and are therefore willing to let it be decided for you; if the MRIs and neurologist exams done throughout the year would be something you otherwise wouldn't have access to; if you are altruistic and willing to make what could be a personal health sacrifice for the sake of the research. I have to admit my own bias, which is that CCSVI is an effective treatment, but it's studies like Dr. Mehta's that are needed to prove that. It is possible that the sham group will be the lucky ones and that they'll have a better outcome or less risks than the treated group.
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Postby Cece » Wed Sep 01, 2010 9:56 pm

My question for Dr. Mehta would be how many CCSVI procedures he'll have done prior to starting the trial. And if there is anything else he can do to gain mastery of the techniques of finding and effectively treating CCSVI.

I'm Team Mehta, but beneath that shirt I've got a Team Sclafani shirt too, and from him we've heard that it's not yet time to have randomized trials; that they need to get the techniques straightened out and full expertise obtained before such a testing of them.
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Postby MrSuccess » Wed Sep 01, 2010 11:19 pm

Cece -
Dr. Mehta is doing what Dr. S cannot do .... and that is starting a 600 person CCSVI Trial..... NOW .....

It doesn't get any better than that .

Of the 600 ...... 400 will get the Liberation treatment ..... NOW

How can you possibly find ANY fault with that ?

I am certain Dr. Scalfani is pleased with this great news.

Happy Poet - from what I have read in your posts ..... you are a gentle soul ..... and I admire that quality in a person .

The CCSVI story has been quite dramatic at times .... the people involved have gone through hell and high water .... to advance the treatment .

Reading each and every post on CCSVI as it evolved .... was gut wrenching at times . A death. A disasterous stent migration .....
advancements ....... roadblocks ..... uncertainy and out right fear ...in the posts of those involved....

All of those efforts have finally paid off ...... with a great price paid .... to be where we are today. Thousands of pwMS getting treatment from Australia to Kuwait to Poland .... and now the USA.

And finally ....... Clinical Trials .

I say ..... show some respect for all the pwMS and our heroic CCSVI doctors ..... that have brought us to where we are today :idea:

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Postby eric593 » Wed Sep 01, 2010 11:42 pm

Cece wrote:It is possible that the sham group will be the lucky ones and that they'll have a better outcome or less risks than the treated group.


That would mean that the treatment wasn't effective then if the sham group did better than the treated group. That can't possibly be the outcome that you want though since you believe in the treatment, right? It would effectively shut down any future procedures if that were the result.
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Postby Cece » Wed Sep 01, 2010 11:49 pm

MrSuccess wrote:However ..... Dr. Mehta is doing what Dr. S cannot do .... and that is starting a 600 person CCSVI Trial..... NOW .....

Dr. Mehta is doing what Dr. Sclafani chose not to do. (He has stated in his thread that his irb wanted a randomized trial but that he stood his ground on the belief that it was too soon.)

Different choices by different doctors. We are spectators....

Eric, yeah, I think it's highly unlikely that the sham group would come out ahead of the treated group. Just covering all bases. I want the results to be amazingly in favor of CCSVI treatment for all.
eric593 wrote:It would effectively shut down any future procedures if that were the result.

If this is true, then it is very good reason to do a trial carefully and with the best possible techniques.

It's like the Georgetown trial. I read someone here saying that was shut down, that they weren't getting the results they expected. (Looking for confirmation on this.) We have to tread carefully, as much as positive results help, negative could hurt.
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Postby MrSuccess » Thu Sep 02, 2010 8:54 am

Cece - some of your observations are starting to worry me .....

Do you really believe Dr. Sclafani would decline to organize a CCSVI Trial ...... supported by the NIH ? That makes no sense.

Dr. Sclafani had difficulties from his own hospital's IRB .

Now that a CCSVI trial has been activated ..... you are reacting with fear of the results ..... ie ..... the Georgetown rumour ......

Cece .... this CCSVI trial is what is needed TODAY.

As with all CCSVI investigations ..... it will come with mixed results that can and will be seen .... as positive or negative .

I give you ...... the glass is half FULL ...or is it .... half EMPTY ... as an example of what to expect .

I certainly agree with Dr. Sclafani 's opinion that an established method of detection and ----most importantly ---- an established method of corrective CCSVI remedy ..... be the end result .

Do you not agree that Dr. M's CCSVI investigation will not reach that objective after 600 try's ? :wink:

Add in Buffalo ..... Stanford ...... add in all the other CCSVI investigations and their eventual data collaboration ..... and things will look pretty damn good.


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Postby bigfoot14 » Thu Sep 02, 2010 11:39 am

Does it suprise anybody that this study has not been mentioned on the MNSS web site yet? :twisted:
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Postby Cece » Thu Sep 02, 2010 12:02 pm

In defense of the idea that Dr. Sclafani could too do a RCT with sham if he wanted to, he talks about this on page 194 of his thread, in response to me asking, "But the RCTs aren't waiting, are they?" along with his explanation about what happened when carotid stenting first entered RCTs as a new technique. He specifically says that he refused to be forced into a RCT with sham as suggested.

I think these trials are the best thing ever for the CCSVI movement if they get positive results. And the worst thing ever if they end up with lukewarm or nada results.

This is not to single out Dr. Mehta, other docs are moving forward with RCTs too. And for this to be a NATIONAL study is huge. Serious kudos to him.
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Postby marcstck » Thu Sep 02, 2010 3:20 pm

Just want to clear something up here. I applaud the approval of this trial, as a matter of fact, despite my considerable trouble standing, I give a standing ovation…

But-it is not supported by the NIH. It is simply listed on their clinical trials website, which lists all of the clinical trials currently ongoing in the US, The vast majority have no connection to the NIH whatsoever, including this one.

I spoke to an NIH IR earlier this week, and they are still not on board with the CCSVI hypothesis. Not ruling it out, not ruling it in, but judging from my conversation, they're highly skeptical…
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Postby bestadmom » Thu Sep 02, 2010 3:46 pm

Cece is correct that DR. Sclafani chose not to acquiesce to the IRB at his hospital and use the protocol Dr. Mehta is. The only way Dr. S can get an IRB approved by an outside source, which is what the Hubbards, Mehta, and Dr. Lynn in West Palm have, is by treating outside of his employer's hospital. Since he isn't in a private practice, his choices are limited.

I know for a fact that Georgetown has ceased it's treatments,. The outcomes were not what they wanted - patients restenosed and they wouldn't retreat them. Also, the azygos wasn't properly imaged and to do so midstream meant changing a fixed protocol.

Considering the Georgetown outcomes, Dr. Sclafani has a good point when he says treatments needs to be standardized. It's a very new field with lots to learn. It's going to take a while and I am glad I am a guinea pig. My outcome hasn't been positive, but I still believe that once Dr. Sclafani gets another shot at my jugulars, he'll liberate me.
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Postby MrSuccess » Thu Sep 02, 2010 4:24 pm

marc - thanks for rounding up that information -

Happy Poet regarding the NIH approving Dr. M's trial.

sources are ?



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Postby marcstck » Thu Sep 02, 2010 5:12 pm

MrSuccess wrote:marc - thanks for rounding up that information -

Happy Poet regarding the NIH approving Dr. M's trial.

sources are


Mr. Success


The confusion probably arose out of the fact that the trial is listed on the clinical studies.gov website, which is "a service of the United States National Institutes of Health". Easy to understand how such a mistake to be made. I think I previously stated that the site lists all US research, which is a misstatement. It actually lists most of the research being done worldwide.

The citation regarding the study doesn't make it clear who is doing the funding. They could be getting funding from a national source, but I can't find that info.

Generally speaking, the NIH carries out its research at its own facility in Bethesda, Maryland. They do, though, provide grant money to outside organizations…
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Postby Drury » Fri Sep 03, 2010 11:15 am

Wouldn't it make sense for all doctors to be on the same page before a trial is put into action? If they are not sharing information and going about it their own way isn't that a recipe for disaster?

I do not understand why they cannot pool their information and come up with a unified method of testing and then have trials?

Am I missing something here?

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Postby HappyPoet » Fri Sep 03, 2010 1:22 pm

bestadmom, I think of you as a hero.

Marc, thank you for your time researching the NIH and clinicaltrials.gov, for understanding how such a mistake could be honestly made, and for the important clarification you gave us.

Everyone, I apologize for the confusion my mistake caused.

Cece, you spoke of choosing your words carefully -- to me, trying to participate here is sometimes like walking in a minefield.
Last edited by HappyPoet on Sat Sep 04, 2010 4:58 pm, edited 1 time in total.
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