This Is MS Multiple Sclerosis Knowledge & Support Community

Later in his life, my dad used to come up the stairs and emerge from the basement. If you asked him where he'd been, he'd say he'd been 'in the hereafter.'

If you remained curious he would tell you that whenever he went there, he couldn't remember what he was here after.

Now I feel like that nearly all the time.

1eye, that is a charming story of your Dad. It's funny seeing ourselves become our parents.

Dear Dr Sclafani,

I’ve recently learned that Dr Zamboni said that IJV narrowing caused by the sternocleidomastoid muscles in the neck is secondary to problems with the valves inside the vein.

If we ignore the potential issue with valves for a moment, then is it reasonable to speculate that blood flow in an IJV can be reduced just as easily by outside compression (things like pressure from muscles, or pinches from bones) as it could be by a narrowing inside the vein?

I ask because having looked at my MRV it is clear to see that my right IJV is being flattened by the SCM muscle in my neck. Other veins are being flattened too but I’m not sure what these are. Blood flow in my jugulars has also been measured by ultrasound and showed that if I turned my head one way it was only 4 cm/second, but if I turned it the other way it shot up to 200cm/second.

These figures don’t mean much to me so I wonder if you have any figures from your own patients that I can compare mine to?

Best wishes.

Hi Dr Sclafani!!
thanks for being here and asking for participation, it is fun to be part of the solution.

To test this the results of PTA how about testing mean transit time before and after treatment?

After all, the neuros have been defining MS in terms of immunology for decades 'MS is an inflammatory disease thought to be autoimmune..."

Well it can also be defined in terms of its circulatory characteristics, can't it. Slow mean transit times are well known and part of regular MS medical literature that doesn't have the "taint" of CCSVI on it.

What if MS were defined as "A neurological disease with the circulatory chracteristic of slow mean transit times resulting in lower tissue perfusion..."

Then went on to show that PTA ends that characteristic of MS......

THAT would establish it as a treatment that removes a symptom of MS without establishing necessarily that it stops MS at all.

This could be seen as similar to the rheumatoid patient getting a synovectomy (an operation to remove overgrown synovium that does not cure RA at all but helps the knee swelling--it is palliative.)
marie

drsclafani wrote:

Have you heard anything back from first review by the IRB?

they wanted clarifications from the abstract, more details about the measures of the study

I don't suppose it is appropriate to ask every day, "Are we there yet??"... but it is on my mind.

1eye wrote:For testing, why not just open your practice to first-come, first-served treatments, and make your control someone some way down the list. Test them before the treatment of the ones ahead of them in the list, so they can act as controls, and test them again before their treatment to see how they compare to the first test.

The only flaw that I see in this: everyone savvy enough to have found their way to Dr. Sclafani's list at this early stage in the CCSVI revolution has also probably found their way to other lists as well. I am currently on three (Mehta, Sclafani, Siskin) so to make anyone on the list a control, I don't think we're the type to sit around waiting for two years or even one year without getting more active in search of someone who will do this outpatient procedure.

mrhodes40 wrote:This could be seen as similar to the rheumatoid patient getting a synovectomy (an operation to remove overgrown synovium that does not cure RA at all but helps the knee swelling--it is palliative.)

Huh, I like this idea! If we could just find the shortest line between research and treatment for all, maybe this could be it? All the research might still need to play out, to determine just where CCSVI falls between palliative and the cause/cure/be-all-end-all, but it would be okay if people getting treated in the meantime.

Cece wrote: I don't suppose it is appropriate to ask every day, "Are we there yet??"... but it is on my mind.

When my daughter was young, and subjected to me this question while on trips, I used to answer: "Halfway."



Donnchadh

Cece wrote:I don't think we're the type to sit around waiting for two years or even one year without getting more active in search of someone who will do this outpatient procedure.

That is probably a foregone conclusion for everyone here at TIMS, but in the broader universe of people with MS, there are probably many who are conservative by nature and might be happy to wait for all the pioneers to discover whether there are problems with venoplasty and whether the benefits are significant enough to do it.

To avoid skewing the data, it would be necessary to match this untreated group with those being treated in terms of disability and I think you have to randomly select who goes into which treatment arm. People who end up in the delayed treatment arm could drop out, hopefully in the beginning so they can be replaced by others willing to wait.

There are probably issues with taking this approach.

He has said that, if he can treat ten people a week, he would get through the entire list by December...so we are not talking about very many months of control data, unless the list has been growing?

Hi everyone.
Dr. S I have looked through the information on the test from SF 36.org
http://www.sf-36.org/tools/sf36.shtml
It is beyond me, although after looking to find an established test, it does appear that the literature gives it the closest detail for our purpose. They quote many fields that would be important for your study trial. There is if I understand correctly software that can analyse the data produced. I believe that it may not be subtle enough for the purpose though.
From what I can see there is data usable for normal controls, although I don't see or understand it myself, maybe its in the Manuel form of the program.
I am guessing that this would need to be trialed to assess whether it would fit the purpose and or could be modified to suit.
I am of the feeling that like so many other assessments it is relying on patient assessment to much without the subtlety of a external measurement that is transferable and repeatable with accuracy.
Maybe a starting point for design of something new though?

1eye wrote:Dr. MacDonald claims to be following a rigid protocol he got from traveling to Ferrara. Can you say what the difference, if any, is between yours and his diagnostic technique. If not, will you get that information from him or from a trip of your own?

As far as I can see, lack of information and deliberate misinformation are the main things enabling all the FUD. Dr. Haacke has designed a very sensitive test for blood oxygen do you plan to acquire a machine of your own? How are you/are you intending that any of your patients in the test get other testing besides dye-based venography?

I hope you have the approval of an IRB soon. Is there money delaying it that needs to be followed?

1eye
Our ultrasound protocol comes from the articles written by Dr. Zamboni. I cannot tell you whether dr macdonald and I have the same protocol. However both his and my teams will be sharing time in Ferrara in June

we will try some new technology soon but it is all research oriented right now.

NZer1 wrote:Two things. The thing we value most or measure ourselves by will be the thing we want back most of all. IQ, physical, parenting, income earning, supporting others, independence,,, etc.
Second thing. The trial/next group of treatments could have groups that have targeted specific outcomes based on their symptom type. The chances of getting success can be greater if the groups are loaded so that historical success from those who have already been treated is used as the learning curve to choose the symptom type in groups which will improve the success of each trial group.
Successful outcomes are more likely and a group that is more for compassionate and QOL reasons can become purely for study purposes and enables them to be treated.
In other studies of drugs the same methods are used but not acknowledged or advertised.

I would think that we need to stay the course and validate the original study of zamboni, identify technical problems and solutions, see which symptoms and signs are improved, which are not, what the incidence of restenosis is, what the complications are, etc.

It is premature to do studies for that are more specific.

Oceanlu wrote:Dr. S,
I have a baclofen pump. Can an MRV be done on me?

most ports are not made of ferromagnetic materials. You will have to have your radiologist investigate your particular port design and materials. Ask whomever put it in to tell you the brand and model

mrhodes40 wrote:Hi Dr Sclafani!!
thanks for being here and asking for participation, it is fun to be part of the solution.

To test this the results of PTA how about testing mean transit time before and after treatment?

After all, the neuros have been defining MS in terms of immunology for decades 'MS is an inflammatory disease thought to be autoimmune..."

Well it can also be defined in terms of its circulatory characteristics, can't it. Slow mean transit times are well known and part of regular MS medical literature that doesn't have the "taint" of CCSVI on it.

What if MS were defined as "A neurological disease with the circulatory chracteristic of slow mean transit times resulting in lower tissue perfusion..."

Then went on to show that PTA ends that characteristic of MS......

THAT would establish it as a treatment that removes a symptom of MS without establishing necessarily that it stops MS at all.

This could be seen as similar to the rheumatoid patient getting a synovectomy (an operation to remove overgrown synovium that does not cure RA at all but helps the knee swelling--it is palliative.)
marie

this is all semantics. we can argue about what constitutes MS or CCSVI, but we dont treat MS or CCSVI, we treat a patient. so showing improved flow is nice, but if it doesnt make the patient more alert, more vital,stronger, less pain, etc, it doesnt matter.

Lets keep the focus on the treatment and the outcomes and the learning

Cece wrote:

drsclafani wrote:

Have you heard anything back from first review by the IRB?

they wanted clarifications from the abstract, more details about the measures of the study

I don't suppose it is appropriate to ask every day, "Are we there yet??"... but it is on my mind.

not there yet. they will go at their own pace

1eye wrote:For testing, why not just open your practice to first-come, first-served treatments, and make your control someone some way down the list. Test them before the treatment of the ones ahead of them in the list, so they can act as controls, and test them again before their treatment to see how they compare to the first test.

The only flaw that I see in this: everyone savvy enough to have found their way to Dr. Sclafani's list at this early stage in the CCSVI revolution has also probably found their way to other lists as well. I am currently on three (Mehta, Sclafani, Siskin) so to make anyone on the list a control, I don't think we're the type to sit around waiting for two years or even one year without getting more active in search of someone who will do this outpatient procedure.

cece
that is true, cece. perhaps there will be some who are more willing to find out whether this is an effective treatment before they have it done. PerhapsI will have to partner with a neurologist who does not believe in ccsvi who has patients that will follow him or her. They could be the controls. afterall, not all 500,000 patients are going to be treated in the next year.

I remind you, that having the procedure is only one part of this treatment. There is much followup necessary.

Cece wrote:He has said that, if he can treat ten people a week, he would get through the entire list by December...so we are not talking about very many months of control data, unless the list has been growing?

cece i hope to treat ten people a week. It might take me some time to get to that rate.

the list has continued to grow. but it doesnt yet include all 575,000 patients from north america yet.