This Is MS Multiple Sclerosis Knowledge & Support Community

Posted: **Mon Sep 13, 2010 5:48 am**

As soon as the sites are ready, their contact information will be posted

Posted: **Mon Sep 13, 2010 6:01 am**

Yeh, Minneapolis. Hope it isn't long before they are participating. I'm so excited!!!!!! Thanks to Dr. Hubbard.

Posted: **Mon Sep 13, 2010 3:26 pm**

This is great news. I think we are witnessing an amazing adventure unfolding before our eyes.

BTW does anyone know what if anything they will use as a placebo group?

Posted: **Mon Sep 13, 2010 3:38 pm**

David, this is a registry, not an experimental study.

Posted: **Mon Sep 13, 2010 4:20 pm**

Thanks Cece for posting this! BC Canada ? ? How wonderful and how exciting! Fabulous!! let's keep the ball rolling.

Posted: **Wed Sep 15, 2010 12:12 pm**

Bump...now up to 55 sites

Posted: **Wed Sep 15, 2010 1:05 pm**

Cece wrote:David, this is a registry, not an experimental study.

Cece I don't like to disagree with you because the last time I did you were right.

But as I understand it, the registry is a list of medical facilities that will participate in the study. Hubbard's website says:

"This is a multi-center registry of CCSVI Testing and Treatment at interventional radiologist facilities all around the country. In this new Registry study, qualified IR may participate if they abide by the protocol that requires objective testing by an outside MRI facility and clinical and MRI evaluations for restenosis or disease progression at 6 and 12 months after treatment. Any treating physician may refer his/her patient with suspected CCSVI, including but not limited to MS. After informed consent is obtained by the participating IR center, the patient is referred to a nearby MRI facility for the Haacke Protocol which will be reviewed by Magnetic Resonance Innovations, Inc. If positive, the IR will perform catheter angiography and if appropriate venoplasty . The patients will be evaluated before and at 6 and 12 months by MRI and disability ratings."

So part of the intent is to provide Liberation treatment at local providers around the country and part of the intent is to show that Liberation either works or not. But I think the later part will require a control group that gets a placebo. Otherwise there is nothing with which to compare the success rate. Possibly they could use the placebo results from the many drug tests done in the past if they aren't proprietary.

OK now shoot me down ... again.

Posted: **Wed Sep 15, 2010 5:50 pm**

David1949 wrote:
Cece wrote:David, this is a registry, not an experimental study.
Cece I don't like to disagree with you because the last time I did you were right.

I've already forgotten this. (thanks MS memory!) So we're good.

But as I understand it, the registry is a list of medical facilities that will participate in the study. Hubbard's website says:

"This is a multi-center registry of CCSVI Testing and Treatment at interventional radiologist facilities all around the country. In this new Registry study, qualified IR may participate if they abide by the protocol that requires objective testing by an outside MRI facility and clinical and MRI evaluations for restenosis or disease progression at 6 and 12 months after treatment. Any treating physician may refer his/her patient with suspected CCSVI, including but not limited to MS. After informed consent is obtained by the participating IR center, the patient is referred to a nearby MRI facility for the Haacke Protocol which will be reviewed by Magnetic Resonance Innovations, Inc. If positive, the IR will perform catheter angiography and if appropriate venoplasty . The patients will be evaluated before and at 6 and 12 months by MRI and disability ratings."

So part of the intent is to provide Liberation treatment at local providers around the country and part of the intent is to show that Liberation either works or not. But I think the later part will require a control group that gets a placebo. Otherwise there is nothing with which to compare the success rate. Possibly they could use the placebo results from the many drug tests done in the past if they aren't proprietary.

OK now shoot me down ... again.

There are different types of trial design. The best possible design is a prospective, placebo-controlled, large-scale, multi-center/multi-practitioner research trial. A registry is not that. But just because it is not the best possible design does not make it without usefulness. It's a fair bit cheaper to run and it's a way to collect the data that is otherwise going to waste, as we get our procedures done clinically.

I did a quick search but didn't come up with the definition of a registry or the list of different types of trials. This popped up, it may help define it somewhat:
http://www.stacommunications.com/journa ... DF/041.pdf

Posted: **Wed Sep 15, 2010 6:54 pm**

ppicklee wrote:Thanks Cece for posting this! BC Canada ? ? How wonderful and how exciting! Fabulous!! let's keep the ball rolling.

How does that work, if a Canadian center gets involved? Is it that it must be a for-profit clinic?

Of local interest to me, thank you to whoever mentioned there were more up: now there is not just a Minneapolis but a St. Paul and an Eau Claire, WI as well! (That's less than a 2 hour drive.) Three sites within spitting distance!!!

As soon as a site disqualifies, they will be removed.

Pleeease no disqualifications, we want 'em all!!!

Posted: **Thu Sep 16, 2010 5:55 am**

Cece wrote:

Of local interest to me, thank you to whoever mentioned there were more up: now there is not just a Minneapolis but a St. Paul and an Eau Claire, WI as well! (That's less than a 2 hour drive.) Three sites within spitting distance!!!

That was me....and with 5 sites in the Chicagoland area that are all within an hour of me....my wife & I are pretty excited as well

Posted: **Thu Sep 16, 2010 6:23 am**

Cece wrote:How does that work, if a Canadian center gets involved? Is it that it must be a for-profit clinic?

That would be my guess but I still ?? how this will work? Pretty sure that the private clinics in Canada run as an extension of, and under the same rule as the public system.

Dr Godley, he's our man.. if anyone can do it, Dr Godley can!!!

Go FCSC!!

ohhhh..

Posted: **Thu Sep 16, 2010 6:01 pm**

So is the registry listing places across the US that are going to be providing testing and treatment? Someone please clarify this for me...

And in regards to Vancouver BC, as I live in Canada and given what's going on here, why is a Canadian site mentioned? Could this in fact be Dr. Mark Godley and the center he has in Vancouver? (Hope so) I guess it's anyone's guess at this point, isn't it?

Posted: **Fri Sep 24, 2010 2:24 pm**

With thanks to garyak, this was posted in his CCSVI-treatment-success-story thread:

garyak wrote:Dr. Hubbard felt that in a few weeks that he will have a handful of clinics up and running. I got the feeling that he was welcoming any and all IRs into the IRB. He also said that his website has had over 20,000 hits in the last week or so since he announced the national IRB program. He also said False Creek in Vancouver Canada has an IR lined up and are hoping to get in on this IRB.
Wowwy

So yes, that is Dr. Godley's clinic. And we might be looking at just a few weeks before some of those dots turn red.

Posted: **Fri Sep 24, 2010 5:17 pm**

When I spoke to Dr. Hubbard on Monday he said that there were over 80 interested IRs wanting to get in on his national IRB

Posted: **Fri Sep 24, 2010 5:38 pm**

This truly is exciting everyone, pray these dots turn red and soon.

This Is MS Multiple Sclerosis Knowledge & Support Community

Hubbard Foundation CCSVI Multi-Center Registry is approved

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