canadian headed to albany for ccsvi trial

[blossom]

First Saskatchewan resident heads to U.S. for possible MS liberation therapy
Published on Thursday August 16, 2012
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The Canadian Press

SASKATOON — A Saskatchewan man who is going to the U.S. to see if he can take part in the so-called liberation treatment for multiple sclerosis says he’s both terrified and excited.

Andrew Dahlen is the first Saskatchewan resident to go to Albany, N.Y., for the final eligibility screening in a two-year, double-blind clinical trial.

The province is putting up $2.2 million to have 86 Saskatchewan patients take part.

The nature of the double-blind study means half of those participating in the trial will receive liberation therapy and half will get a placebo procedure.

Dahlen says even if he were to get the placebo, that would still be good research on the progression of MS.

The 28-year-old Saskatoon resident also says the possible benefit would outweigh the risks.

The therapy was devised by Italian physician Paolo Zamboni, who has suggested MS may be caused by narrowed veins that prevent blood from properly draining from the brain. He says that could result in iron deposits that damage neurons. Zamboni calls the condition chronic cerebrospinal venous insufficiency, or CCSVI.

His treatment uses balloon angioplasty to open up the veins in the same way coronary arteries narrowed by plaque are unblocked.

The U.S. Food and Drug Administration issued a warning in May about liberation therapy.

The FDA warned health-care professionals and patients that injuries and deaths have been associated with the use of the experimental procedure.

[CureIous]

Thanks for posting this, I saw this article yesterday and thought it great that we have our Canadian brothers and sisters traveling to the US to take part in a double blinded study. Well at least they didn't leave out the FDA warnings, thankfully we have enough warnings to choke a horse. Good luck to him and his results. Very exciting news either way.

[erinc14]

why will it take 2 years ?

[Cece]

I guess they want to collect two years worth of data. Two years is fairly standard in MS drug trials. It's terribly long for the patients who end up in the sham arm to have to wait two years before actual treatment. Then again anyone in Canada who cannot afford CCSVI treatment has already waited nearly three years (since the 2009 CTV broadcast). The researchers may release preliminary results before the full two years is up.

Here's the study details: http://clinicaltrials.gov/ct2/show/NCT0 ... svi&rank=2

It talks about secondary patency so I think patients who restenose will have their veins reopened. That's very good.

[Cece]

Dahlen says that he won't know for 2 1/2 to 3 years which procedure he received.

Wasn't it just yesterday (two years ago) that we were discussing at length whether or not randomized controlled trials would be ethical? And here is one underway. I disagree with the two year duration. The reason for two years is to see the effects of vascular CCSVI treatment on neurological MS. If they were testing the effect of CCSVI treatment on CCSVI syndrome itself, this could be done in a 3 month trial.

It's like not treating someone for heart disease for two years to see what effect treating for heart disease has on MS.

"During the trials, some people will be given the actual procedure while others will receive a placebo treatment. Not even doctors know which one each person will get, until right before it happens. They open up a letter that says venography or venography and CCSVI," said Dahlen.

http://www.newstalk650.com/story/sask-m ... tudy/71089

We do really need the results of such studies, but what a sacrifice on the part of the patients.

"I'm a guinea pig, but if it's for the greater good it's awesome."

[blossom]

whee!! those people got more guts than i'd ever have. i wonder if they are gonna somehow keep an eye on them or have them come in for checkups? as we've seen here there have been some get improvements then restenose some no improvements and end up worse for the wear some blocked up and lost their veins some that probably got it done and never had a recheck you name it. it is kinda iffy to have it done "and know it" and leave a ir's hosp. and never hear much from them or have a real plan if something goes wrong.

i'm with you on this one cece-"i don't agree with how this is gonna be done." maybe we don't know the whole story and the dr.'s involved have a plan. i don't know the ins and outs about how all this works. i want to see research move forward on this too, but. hell i thought us early on ones were guini pigs and i really feel a lot of us really truly did not understand what could go wrong. we were patients not ir's. we'd never had that stuff done before.

well, i pray all goes well for all involved. ---that's a long time to go and not know what was what. "not that some of us know what's what anyway" they say my jugs still have flow but what about my agyous never had that checked and it's not 1-2-3 all that easy. and what i've read on tims those few that have had it checked and it's screwed up aren't doing so hot.

cece, am i getting this right that they all will have angioplasty but some will get ballooned and some not. man, i hope i'm getting it wrong. to get put out, have a wire run through chance scarring etc. like i said, knowing what i do know now-----. i hope the best for all.

[Cece]

cece, am i getting this right that they all will have angioplasty but some will get ballooned and some not. man, i hope i'm getting it wrong. to get put out, have a wire run through chance scarring etc. like i said, knowing what i do know now-----. i hope the best for all.

That's right, they'll all get a venogram done so they'll get the catheter in the veins starting at the femoral vein access and up to the jugulars. And the ones whose papers say venogram will just get the flouroscopy images taken of their stenoses but no ballooning. The ones whose paper says venogram + CCSVI will get the ballooning.

There has been two years now since Dr. Siskin became openly available as a provider treating CCSVI. That's a lot of time to gain experience and improve techniques. Then again there is great variance in techniques among the IRs. That says that techniques are not yet optimized and standardized.

I know I would pay out-of-pocket for the CCSVI procedure before signing up for a sham trial of such long duration. I wouldn't want to leave control of a major health decision up to chance! But I understand that the patients will be getting follow-up ultrasounds and follow-up procedures if they restenose, because the doctors will be measuring secondary patency, and secondary patency means how well the vein stays open after a restenosis is opened. That makes it a really sweet deal for the ones who actually get the venogram + CCSVI. Luck of the draw....

[tiltawhirl]

I still don't undertand just how people aren't going to know they got the sham procedure.
I was in a great deal of pain for brief periods as the ballons were being inflated. I just don't see how patients won't know this fact with a simple search. The patient would have to unconcious for this to work.

tilt

[blossom]

they put me out like a light. i felt nothing heard nothing. i had no bruseing i had no soreness to speak of. but, when i woke up i had a numb leg and this has given me extreme grief ever since. although i asked repeatdly why is my leg so numb i was offered no explanation from them. my pcp and another dr. familiar with me and my symptoms for over 15 yrs. concluded that the femoral vein and femoral nerve being so close the nerve had gotten injured. i can't help but feel the ones doing the procedure had a pretty good idea what happened. so when it's lights out what goes on in Vegas stays in Vegas.
i have no knowledge of this happening to anyone else but it happened to me. so, there's another unspoken risk that these volunteers are exposed to.

[Cece]

from the exclusions listed in the trial details

Exclusion Criteria:

•Patients with a contraindication to drugs used for conscious sedation during interventional procedures, including Versed and Fentanyl

I had fentanyl during my procedure, but what is versed? How much would be felt/remembered when on versed? If it weren't midnight I'd look it up.

[Cece]

http://www.cbc.ca/news/canada/saskatche ... ml?cmp=rss

But Dahlen said when the study is done, if he finds out that he didn't get the therapy, he'll pay to get the treatment himself.

They aren't going to provide the procedure for the people in the sham group at the end of the trial? I thought they would, if the patient wanted it and/or if the research bore out the benefits.

It's exciting to read about the launch of this trial. It definitely raises my hopes that we'll get some positive data coming in to support the treatment. When I first learned about CCSVI, the word here at TiMS was that Dr. Dake was going to have a trial underway at the start of the new year. That new year was 2010. Now we have Dr. Siskin's trial underway and I'd like to see Dr. Dake's trial underway soon and let's get some traction going on the actual treatment research.

Definitely wishing the best for Andrew Dahlen and all the participants in this trial.