PREMiSe study results

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

Re: PREMiSe study results

Postby NZer1 » Tue Apr 16, 2013 3:32 am

Another point to add to the list, is that the phase 2 PTA treated (non sham) people were technically not 'treated'.
The outcome percentage or flow created from the PTA was not to a 'standard' that is defined as optimal for symptom or progression altering measurable by xyz testing.
Dr S long ago stated that the testing procedures or landmarks in MS were not detailed enough and asked support to find or design better that would be industry accepted for multicentre use. The Ebers study and report has come out since and using meta analysis shows the failure of the test methods used for MS treatment outcomes.
Dr Zivadinov has publicised previously other improvements such as CSF improvements measured by Cine MRI and this was not used in the mix for this trial?
MRI imaging of lesions is known to change monthly independent of symptom changes, this has been studied and peer reviewed articles exist, MRI findings also do not match the symptoms as has been stated years ago, so what is happening at BNAC?
Who looked comfortable and who looked very uncomfortable and was cut short in the staged PR interview, WHY?
So many conflicting things that were known would discredit this trial were used from get go, WHY?

It appears that there is a rift inhouse at BNAC and a power struggle exists to direct CCSVI and MS learning. Does BNAC have issues with research direction that has caused this screen play?

;)
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Re: PREMiSe study results

Postby centenarian100 » Thu Apr 18, 2013 3:08 am

marcstck wrote:So much potentially vital information has been lost due to the lack of long-term tracking of CCSVI treatment patients. Of the 30,000 patients treated, we only know the outcomes of a tiny percentage. It's really a shame…


indeed.
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Re: PREMiSe study results

Postby centenarian100 » Thu Apr 18, 2013 3:13 am

NZer1 wrote:Who looked comfortable and who looked very uncomfortable and was cut short in the staged PR interview, WHY?


Is someone in bed with Dr. Zivadinov?! DUN DUN DUUUUUUN!
:roll:
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Re: PREMiSe study results

Postby NZer1 » Thu Apr 18, 2013 1:09 pm

centenarian100 wrote:
NZer1 wrote:Who looked comfortable and who looked very uncomfortable and was cut short in the staged PR interview, WHY?


Is someone in bed with Dr. Zivadinov?! DUN DUN DUUUUUUN!
:roll:


I saw that Dr Z was uncomfortable and I think that was an indicator he was put in a situation by others. I personally think he is not happy with the performance of BNAC regarding this trial. Just to clarify!

;)
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Re: PREMiSe study results

Postby Robnl » Thu Apr 18, 2013 9:38 pm

I still think it is all in the 'game' bnac is playing. I suspect a 'it's logical that the results......, because...' will come. They did it before...
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Re: PREMiSe study results

Postby NZer1 » Thu Apr 18, 2013 10:47 pm

I had the thought earlier and haven't started going on about it yet. Thanks to Carol Schumacher for reminding me :). So I will start,
Dr Zivadinov has spoken frequently about the Thalamus pathway and the atrophy found in the Thalamus region in PwMS. It may have give some credibility to the recent study if it linked genuine other recent MS findings rather than the methods of measurement used which are said to be inappropriate for MS studies by the Ebers paper! The other aspect of recent finding the Fox pathology and silicon visual proof of Vascular issues is another milestone for CCSVI which would create test insights for future measurement options in CCSVI research projects.
Both of items of measurement of defined issues have been avoided in the BNAC Phase 1 and Phase 2 stages, WHY?

Abstract
Arterial spin labeling (ASL) is a noninvasive technique that can measure cerebral blood flow (CBF). To our knowledge, there is no study that examined regional CBF of multiple sclerosis (MS) patients by using this technique. The present study assessed the relationship between clinical presentations and functional imaging data in MS using pseudocontinuous arterial spin labeling (pCASL). Twenty-seven patients with MS and 24 healthy volunteers underwent magnetic resonance imaging and pCASL to assess CBF. Differences in CBF between the two groups and the relationships of CBF values with the T2-hyperintense volume were evaluated. Compared to the healthy volunteers, reduced CBF was found in the bilateral thalami and right frontal region of the MS patients. The volume of the T2-hyperintense lesion was negatively correlated with regional CBF in some areas, such as both thalami. Our results suggest that demyelinated lesions in MS mainly have a remote effect on the thalamus and that the measurement of CBF using ASL could be an objective marker for monitoring disease activity in MS.
http://www.sciencedirect.com/science/ar ... 5X13001021

** Why was this NOT an outcomes measurement in the recent BNAC trial where they were testing 'safety' and then the minimum amount of PTA treatment required for the change in symptoms or other measurement?
It is getting to the point where egos seem to be flexing towards saying that CSF flow changes matter more than the original Franz Schelling findings and the Dr Zamboni assessment systems of reflux/back jets that are observed in MS and seen on Fonar Upright MRI.**

:)
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Re: PREMiSe study results

Postby Cece » Fri Nov 22, 2013 6:15 am

http://www.prweb.com/releases/2013/11/prweb11353748.htm
Press release on PREMiSe from VEITH symposium.
Ah, salt in the wound.
PREMiSe is believed to be the first prospective randomized double-blinded, controlled study of balloon angioplasty for MS performed with Institutional Review Board approval in a rigorous fashion in the U.S. with significant safeguards in place to ensure careful determination of risks and benefits. All screening, diagnostic, interventional and follow-up procedures and visits were performed at no cost to the patients.

"The study’s key findings are that while the treatment is safe and was not associated with serious adverse events, it did not provide sustained improvement in MS patients,” explained Zivadinov.

The trial enrolled 30 MS patients. Phase 1 was a safety trial, involving 10 MS patients and Phase II involved a total of 20 MS patients, who were randomized to receive treatment or placebo. Researchers found no difference in clinical symptoms, brain lesions as determined on MRIs or quality of life outcomes between MS patients who underwent balloon angioplasty to correct CCSVI and those who did not receive the treatment.

It was an underpowered study with not enough patients enrolled. The FDA then required studies to have a higher number of patients (Dr. Siskin's trial was asked to enroll 200) which is part of why that trial was stopped. Can't win either way. At least the safety findings have continued with the procedure being safe with no adverse events in the PREMiSe study, which admittedly is small.
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Re: PREMiSe study results

Postby NZer1 » Fri Nov 22, 2013 10:51 am

Cece I think that having two objectives is a good way to achieve results that have meaning.

The key point here is that the first objective of testing the safety of the procedure has once again shown safety is not a risk factor under the care of an experienced CCSVI IR.

The second part of this study asks a very different question and uses measuring techniques that haven't been proven to be accurate for the task of defining MS disease markers, "Researchers found no difference in clinical symptoms, brain lesions as determined on MRIs or quality of life outcomes between MS patients who underwent balloon angioplasty to correct CCSVI and those who did not receive the treatment." So can these conclusions be considered trustworthy?

If for instance if PTA is performed and an outcome of a 20% improvement in flow has been achieved, is the measurement of 20% the outcome a success or would a change in symptoms for the PwMS be a successful outcome?

It appears that the unsaid % gain from the PTA by BNAC has been used as the measurement for PTA targeted success, BUT, has it not been studied or trialled to show it is there is a required minimum improvement before PTA can be purposeful, AND it has not been shown that there may be unseen or unknown 'other' flow impediments causing flow problems other than the jugulars!

If for instance 70% improvement is said to be a target outcome but does not show symptom improvement then is the trialling at 70% the best target outcome?

If for instance 78% improvement gives symptomatic improvement and greater than 78% improvement gives more consistent benefit then would the statement of assumptions by the BNAC Team be correct in saying that " "The study’s key findings are that while the treatment is safe and was not associated with serious adverse events, it did not provide sustained improvement in MS patients,” explained Zivadinov."

It appears that the second half of the statement is UNTRUE!

:)
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Re: PREMiSe study results

Postby cheerleader » Fri Nov 22, 2013 11:02 am

...and....
more PR but no published paper. Still only that damn poster. How is this possible?
Seriously. The only published paper to come out of PREMiSe is phase one that showed improved CSF flow in patients treated in Italy.

I do believe it's because phase 2 did not meet the end point of 75% improvement in venous flow, only maintaining less than 50%. The patients in the sham end of the trial had the same, exact level of venous hemodynamic improvements as those that were treated. They did not correct CCSVI.

from the never-published study poster:
• In phase 2, improvement was observed also in treatment (p=0.02) and sham (p=0.04) arms at month 1 but did not reach >75% restoration of the venous outflow compared to baseline. No differences in VHISS improvement (Venous Hemodynamic insuffiency Severity Score) were detected between phase 2 treated and sham groups (p=0.894).


http://ccsviinms.blogspot.com/2013/04/a ... il-17.html

why doesn't anyone question this? A trial which cannot reach its endpoint is called a failed trial. And it's tossed into the trash.
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Re: PREMiSe study results

Postby MrSuccess » Fri Nov 22, 2013 2:51 pm

sigh. let me say this once again. In order to advance Chronic Cerebrospinal Venous Insufficiency .... as both an accepted medical diagnosis AND a safe and effective medical procedure ..... certain things have to happen.

Starting with getting CCSVI talked about and published in Neuro circles.

As MrSuccess has learned .... the secret to getting things done ..... is to convince others that it was THEIR idea all along. :idea:

Think about it.


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Re: PREMiSe study results

Postby CureOrBust » Fri Nov 22, 2013 4:48 pm

Cece wrote:
"The study’s key findings are that while the treatment is safe and was not associated with serious adverse events, it did not provide sustained improvement in MS patients,” explained Zivadinov.
If I took a pill (say Fampridine for example) and the effects wore off, I would take another pill. And the drug maker can explain its because the half-life of the checmical in my system.

When they are researching most medical treatments, if they get any change, to me the big question is WHY are these improvements not permanent :?: . Which is what most people are alluding to (ie flow returns to bad flow).

If it has any positive effects, I would not understand why this would not be a burning question at the forefront that would need to be definitively explained.
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Re: PREMiSe study results

Postby ton » Sat Nov 23, 2013 6:41 am

I would like to know what thinks dr Zamboni about the results of this study.
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Re: PREMiSe study results

Postby 1eye » Sat Nov 23, 2013 8:29 am

Is there a paper yet? Meantime we have Dr. Zivadinov working with Dr. Beggs and publishing on it. To have an an corruptible team you need scientists with nothing to gain personally from the results. There are many ways a scientist can benefit from a result: I can think of money, prestige, personal involvement. Some people are disparaged because they think people can have the latter, personal involvement (Dr. Beggs' wife has "MS" as Dr. Zamboni's did). I think that motivation is a much less corruptible one than money. I am having a serious problem with studies going back and forth and people saying CCSVI is Dead Long live CCSVI Zamboni is a twerp Long live Zamboni Freedman is great down with Freedman meanwhile I am dying. Oh, I know "MS" doesn't kill, but my friend died, and the Greek from Detroit died and people have died from the procedure and so-and-so is suing such-and-such, and I CAN'T WALK AND I CAN'T SING and I CAN'T WORK and when are you so called scientists and Doepps and Freedmans and the extremists and the weak-minded and the nosy and the taxpayer, and all of you bickering, whingeing, impotent, nay-saying, meddling, nit-picking, Professional bitches going to offer anybody like me an alternative to this? For God's sake stop this Pharma-ego-turf-Nobel-Prize-competion-patient-protection-slanderous-pseudo-science BULLSHIT. With carers like you, who needs killers? Get off the pot! I don't care what you think. I don't care what you think. I don't care what you think. The press doesn't care about you. Go away! Got it? You copy? Clear?

Calming down, taking 2 lorazepams, drinking hot choclate, spraying nitroglycerine, chanting Hari Krishna Krishna Krishna Hari Hari breathe, breathe, All You Need is Love, Love it could be worse it could be worse it could be worse it could be...you could be in Guantanamo Bay........... aaaaah, I feel much better......never mind.
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Re: PREMiSe study results

Postby Ernst » Wed Nov 27, 2013 12:53 pm

I was going to ask if Buffalo trial is published.. but it isn't yet? Im also wondering why unpublished and small trial, with no correction with blood flow, is so much in media? Study result is used as an proved evidence against CCSVI.. absolutely horrible. Why positive studies, are not in media.. like blinded study from Italy which was recently published and result was very clear that CCSVI is related to MS? Quess this is going to be long war..
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Re: PREMiSe study results

Postby cheerleader » Wed Nov 27, 2013 1:54 pm

Ernst wrote:I was going to ask if Buffalo trial is published.. but it isn't yet? Im also wondering why unpublished and small trial, with no correction with blood flow, is so much in media? Study result is used as an proved evidence against CCSVI.. absolutely horrible. Why positive studies, are not in media.. like blinded study from Italy which was recently published and result was very clear that CCSVI is related to MS? Quess this is going to be long war..


Hi Ernst--
The PREMiSe phase two study has NEVER BEEN PUBLISHED. All this PR, and only a POSTER.
(sorry, I don't usually yell...but this situation has become ridiculous.)

The reason it has never been published? I believe it is because it did not reach its stated endpoint.
No one had >50% restoration of flow, and the endpoint was >75%. The study was a failure.

PREMiSe phase 1 was a SUCCESS. It reached its endpoint of >75% flow restoration.
It is a PUBLISHED PAPER in the Journal of Vascular Interventional Radiology.
http://www.ncbi.nlm.nih.gov/pubmed/23523158
CSF flow was increased, and cerebral hemodynamics were improved for 12 months.
But there was NO PR. Not one press release, not one 2-camera video. Nada, nulla, niente.

BNAC needs to answer to this.
http://ccsviinms.blogspot.com/2013/04/a ... il-17.html
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