The next Buffalo study commences this week

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

The next Buffalo study commences this week

Postby L » Wed Jun 30, 2010 9:04 am

UB researchers launch MS study

University at Buffalo researchers in the department of neurosurgery will launch a study on a new therapy for multiple sclerosis patients.

The double-blind study will test the safety and efficacy of interventional endovascular therapy, known as “liberation treatment,” on MS symptoms and progression.

Dr. Adnan Siddiqui, principal investigator, was featured in a New York Times story about the therapy published June 28. The therapy uses balloons and stents to open narrowed veins based on a theory by an Italian researcher that veins in the neck and chest might cause improper drainage of blood from the brain, resulting in eventual injury to brain tissue.

To remedy these blockages, the Italian researcher, Dr. Paolo Zamboni of the University of Ferrara, has treated MS patients with angioplasty, a treatment commonly used by cardiologists and other endovascular surgeons to treat atherosclerosis. There have been no large studies yet on the efficacy of the treatment, although the procedure has begun to be used by some doctors around the U.S. and abroad on an experimental basis.

Researchers at UB will launch a study to determine if such a therapy to correct blockages will improve MS symptoms or progression. The Prospective Randomized Endovascular therapy in Multiple Sclerosis (PREMiSe) will be the first randomized, double-blind study of balloon angioplasty for MS.

Siddiqui will work with co-investigators Dr. Elad Levy and Dr. L. Nelson Hopkins, both also with UB’s department of neurosurgery.

The first phase of the study is taking place this week, when 10 MS patients from the U.S. and Canada will undergo the procedure at Millard Fillmore Gates Circle Hospital. A second phase will randomize 20 MS patients to undergo either the procedure or a sham angioplasty. Based on the results, researchers will pursue an extension of the protocol to study a larger number of patients.


http://www.bizjournals.com/buffalo/stor ... ily23.html
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Postby Daisy3 » Wed Jun 30, 2010 9:51 am

Do you know how long this study is planned for?

Can we expect the results next year?
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Re: The next Buffalo study commences this week

Postby CureOrBust » Thu Jul 01, 2010 5:59 am

A second phase will randomize 20 MS patients to undergo either the procedure or a sham angioplasty.
Does anyone know what they mean by a "sham angioplasty"? Are they actually going to insert a catheter, but not balloon it?
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Postby Rieja » Thu Jul 01, 2010 6:06 am

Correct. Hence the double blind. People will not know wether or not the balloon actually was inflated though the catheter will be inserted. In this way they can rule out placebo effect (mind over matter).
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First 10 patients

Postby nicknewf » Sun Jul 04, 2010 3:02 pm

Does anyone know how the first 10 patients fared?
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ain't no foolin an MSer

Postby hwebb » Sun Jul 04, 2010 3:19 pm

Double blind...get real. Let me tell you, when they inflate a balloon in your vein you are well and truly aware of the inflation (causes pressure).
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Postby Nunzio » Sun Jul 04, 2010 4:08 pm

Except for the magic of Propofol, the same anesthetic used for colonoscopy;
And Michael Jackson said "it is to die for"
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Postby 1eye » Sun Jul 04, 2010 11:57 pm

With me I think it was a lot of valium. But thanks. Wife gets colonoscopy tomorrow.
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'MS' is over - if you want it
Patients sans/without patience
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Postby Rokkit » Mon Jul 05, 2010 8:54 am

Nunzio wrote:Except for the magic of Propofol, the same anesthetic used for colonoscopy;
And Michael Jackson said "it is to die for"

That's a good point. I had a colonoscopy once and I had zero short-term memory during and for an hour after the procedure. You might be aware of the balloon at the time but you sure won't remember it. If they use that drug, anyway. Good idea though.
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Postby fogdweller » Mon Jul 05, 2010 11:01 am

Rieja wrote:Correct. Hence the double blind. People will not know wether or not the balloon actually was inflated though the catheter will be inserted. In this way they can rule out placebo effect (mind over matter).


Very interesting. Several of us on this web site have been speculating about this. I doubted that it would be ethical to make an incision, insert a catheter, and perhaps prescribe blood thinners on a patient that was not being treated. I guess with adequate informed consent that much of the procedure is safe enough to allow.

Proof of efficacy that does not require 2 or 3 years follow up is another issue. Do you know what measures they intend to use?
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Postby Rieja » Mon Jul 05, 2010 2:57 pm

I have zero medical expertise but if I wanted to make sure that there is no placebo effect, I would knock people out (through an anesthetist I assume) and perform the procedure on some and not the others. Now those going in know the the "rules" of what is happening. Consent must be given.

I truly believe that in the case of CCSVI treatments there is no placebo effect but the scientist in me wants the proof on paper :)
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Postby Vivianne766 » Mon Jul 05, 2010 3:21 pm

Rieja wrote:Correct. Hence the double blind. People will not know wether or not the balloon actually was inflated though the catheter will be inserted. In this way they can rule out placebo effect (mind over matter).



Sounds really stupid to me. What a waste ! :x
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Postby Nunzio » Mon Jul 05, 2010 4:16 pm

I know it sound stupid and even cruel, but it is the only way to progress quickly.Once you have a double blind study showing an effect, nobody can dispute the findings. At the end of the study the patients that did not received the treatment will be treated too and sometimes the key can be broken earlier if there is an obvious benefit from the treatment.
Of course patients that are going downhill quickly should not participate in the study but seek treatment elsewhere.
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UB update

Postby Murchy » Thu Jul 08, 2010 11:31 pm

Latest update from Buffalo... no results, just that the first 10 have been done...

http://www.buffalo.edu/ubreporter/2010_07_07/ms_trial
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Postby MrSuccess » Fri Jul 09, 2010 7:34 am

just reviewed the University of Buffalo newsletters July 5th edition :

Paul Dressel states in his article : The association has been confirmed by independent researchers from many institutions, including UB. :!: :!: :!:

Mr. Dressel closes the article with the following :

Researchers note that if angioplasty proves to be effective in improving MS symptoms , the implications for the future of MS treatment could be monumental

Well worth reading the whole article.

The UB are proceeding slowly and carefully . The first phase is making sure the procedure is SAFE . Which I already have decided .... is .

Some say the study will take years to confirm or deny if the procedure is effective ..... I think not ..... based on testimonials of patients and doctors that have already gone down the CCSVI road.

Good work ... Dr. Zivadov ..... Salute Dr. Zamboni :!:




Stay Calm and Carry On .............




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