DrSclafani answers some questions

[simone]

you know, the more i learn, the more I really don't know what we are treating. If MS is symptom complex related to demyelinization that leads to poor electrical conduction that causes all the symptoms, how can those symptoms so abruptly and dramatically resolve?Certainly there is no remyelinization in an hour. It has to be circulatory. and that IS CCSVI not MS

or is it all the same

and besides who cares right now what we are treating. its the relief that counts, right?

Right!
Yes this is precisely what i have been asking, if the symptoms can so abruptly resolve and return with restenosis, how can it be said to be anything but related to blood flow as the myelin has not been altered and so Many Sclerosis are just a piece of observation and has been named MS , that being only a limited view.
I don't get how a "renown well educated " neurologist can compare this to bee stings.
I hope the plumbing gets fixed soon in the houses now that we have all the modern conveniences it would be great to be able to use the toilet.
Bad joke.

[Squeakycat]

you know, the more i learn, the more I really don't know what we are treating. If MS is symptom complex related to demyelinization that leads to poor electrical conduction that causes all the symptoms, how can those symptoms so abruptly and dramatically resolve?Certainly there is no remyelinization in an hour. It has to be circulatory. and that IS CCSVI not MS

or is it all the same

and besides who cares right now what we are treating. its the relief that counts, right?

Not to disagree, but I think it is how persuasive the results are in terms of gaining acceptance of the fact of CCSVI and the benefits of treatment that is really critical.

It has been suggested that we focus on something simple such as fatigue which the National MS Society says effects 84% of people with MS and we know from anecdotal reports is relieved by venoplasty.

Looking into the various instruments for measuring fatigue suggests that this would be a good thing to measure pre- and post- treatment because;

• ** It is an accepted part of MS disability
  ** Current theories of what causes it are extremely weak
  ** There is a logic to why improving cerebrospinal blood flow would address this problem.

As such, if we can show that Liberation lessens fatigue, we go a long way toward validating CCSVI and its treatment and help sort out what is electrical and what is plumbing in a very convincing way.

But . . .

As you dig a little deeper, there are many aspects of fatigue. It is a symptom of depression and as such is a mental state. It is also physical, a measure of the ability to perform various activities without having to rest.

This suggests to me that we need something broader than just the standard Fatigue Severity Scale and the Modified Fatigue Impact Scale.

I believe that Dr. Zamboni used the MS Quality of Life Scale which includes both, but also looks at a whole range of other self-assessed aspects of the disability which is currently known as MS.

I have about 5 days free to put the whole MSQLI series of questionnaires on line for our use if that makes sense. (Of course, I'd rather not if someone has already done this.)

It takes about 45 minutes to complete the NMSS version of the MSQLI.

Another benefit of using this is that it has been specifically designed for the purpose of having a quantitative set of uniform measures for MS clinical trials.

The manual for MSQLI is available here.

I think the suggestions that we also specifically look at what people with MS believe are their most pressing symptoms, pre- and post- Liberation, is an excellent idea because it can provide a new CCSVI QLI test and perhaps capture things that will be missed by the MSQLI questionnaire.

Since this is already too long, one more thing that may be useful is to administer the questionnaire twice before Liberation to establish the internal consistency of the questionnaire and then do the same at several post-Liberation intervals such as the beginning and end of the first week post-Liberation, beginning and end of the 6th week, post-Liberation.

We will need healthy controls as well as people with MS who do not receive treatment to also participate at each of the test stages, a lot to ask!

[drsclafani]

Were your colleagues receptive?

yes, we shall see what actually happens

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

[NZer1]

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

They say to get to know a man, you need to wear his moccasins for three days.
It sounds like you are wearing the moccasins of a PwMS.
Welcome to our frustrating world!

And TN is as you guessed, MS symptom?, are now there's a question for you. Caused by ? Cured by? Managed by? Big Pharma's drug cabinet!

[costumenastional]

Dear Dr Sclafani,

i dont know if you had the time to check some of my operation captures in my so called blog.
Anyway, i want to clarify that by using your name i only ment that you thought it is possible for a jugular vein flow problem to react with the cervical spinal cord's drainage.
I did it only because somewhere in your thread following a question of mine, you were kind enough to say that cervical spine drains to the jugular veins via a complicated vein system which you described thoroughly. I also remember that you had to look it up to make sure, because i was thinking that crvical spinal cord drains to the azygos at the time.

I really hope i didnt offend you in any way by taking this kind of liberty but if so, please let me know, so i change the picture's caption immediately.

In no way i ment that you agree that MS lesions in the cervical spine are caused by problematic flow in the jugs. It is only a hypothesis for all of us (and a big hope i might add) which will take years to be proven right or wrong.

With all my respect

Spiros.

[Algis]

Doctor: you may recall my inquiry about a total MRV/MRI - The whole package is available in The Netherlands for less than 750€ - Complete body MRV / Complete body MRI / Each principal organ MRI detailed (heart/liver/brain/lungs/kidneys/prostate for males etc...) - You also have to consultancy of vascular specialist, organs specialist, etc...

It isn't that uncommon and would have the advantage of having the whole map....

Sample:



While we are there we could make the whole tour... Laying down all day in a MR coil would change some of us from staying in the wheelchair all day....

[Cece]

you know, the more i learn, the more I really don't know what we are treating. If MS is symptom complex related to demyelinization that leads to poor electrical conduction that causes all the symptoms, how can those symptoms so abruptly and dramatically resolve?Certainly there is no remyelinization in an hour. It has to be circulatory. and that IS CCSVI not MS

I don't see this as a conundrum at all, not if you accept what mrhodes has posted here about the role of the emissary veins in cooling the brain. Let's see...there are facts or links somewhere to back this up, but this is what I remember of the theory...the blood that leaves the brain is warmer than the blood that enters it. Basically it serves as a cooling system.

In an MS/CCSVI brain, the blood does a poor job of carrying away this excess heat. That heat, coupled with the demyelinization, leads to poor electrical conduction and some of the symptoms. When an IR doc works his common-day miracle and opens up those veins, they are able to function to cool the brain. The demyelinization is still there, but the overheating is gone, and the effects are both abrupt and dramatic.

What I like about this is that it helps tie in not only the operating room improvements but also the cold feet/hands and heat intolerance symptoms.

[tzootsi]

Dr. Sclafani,

Since you are trying to collect data, I thought I'd fill you in on my wife's case. She has a mild case of MS, dx'd about 3 years ago. Her most troublesome symptom is a heavy right leg. She also has several other typical ms symptoms - l'hermettes, burning skin, morning spacticity, cold right hand, no real fatigue (other than the kind she gets during prolonged walks). Anyhow, five weeks ago she had the procedure done - ballooning in both jugulars, and it went very well. Interestingly it was performed by someone who you used to work with. Shortly after the procedure, her cold right hand became noticeably warmer. Lately, her l'hermettes has subsided, as has the spasticty. On a few occasions, her heavy leg has felt better, usually in the evening.
Symptoms she'd like to see improve - heavy right leg and walking ability are by far the biggie. Since she does have short bursts of leg improvement, we're hoping it can eventually become better. Any idea why her leg improvements come on in the evening?

[magoo]

Dr. Sclafani,
As far as what symptoms have been the most important to improve for me, it has to be the cognitive ability and fatigue. You can do most of what you want when you can think clearly and can get out of bed. I've had improvements in all of my symptoms, but these are the most valued in my opinion. They also seem universal to CCSVI most of the time.

[bluesky63]

I agree one thousand percent with Rhonda. (See, there's that clear math.) I have had a severe and disabling course of multiple sclerosis with symptoms in pretty much every functional system, and people always assume that I really want to address the mobility most of all, but so much of that is logistical and belongs in the realm of universal design and advocacy. If the world were designed differently wheelchairs wouldn't matter. But I digress.

No doubt at all -- the issue that has caused the most grief in my daily life is the severe cognitive problems and fatigue. When people I've known for years come up to me and start talking and I don't know who they are . . . when I get lost every day in my own town . . . when I can't follow my own children's delightful conversation . . . when I wake up with food in my mouth and the imprint of the keyboard on my face and it's still just morning . . .

Oh yeah, that plus headaches. PLEASE no more headaches. And if I might be so bold as to add one more big wish without being greedy . . . it would be so, so nice to have my head and face and vision feel halfway normal again. Not dizzy-heavy-spacey-numb-can't-even-feel-myself-when-I-eat-or-breathe-or-bite-or-rub.

I am the single parent of three wonderful children, and I would give anything to be the parent they deserve. If I could read them a story without falling asleep on the first page, help with homework, play games with my eager son who has no memory of me without a wheelchair in our life, just do any normal kid-parent things. Even hugging is planned so I won't get hurt or fall over. That's tough to explain to a loving little boy.

Hmmmm. I just read this over, and it looks to me like my most pressing symptoms are head-related -- the feeling like I might explode if I lean too far forward, being so unbalanced, vision, confusion, various cranial nerve problems, etc. Migraines too. I also have a venous angioma and seizures. Maybe a simple head transplant would do it.

[fogdweller]

Dr. S. and all those designing studies:

There is a whole thread just listing potential symptoms/issues that mi9ght be good characteristics/fesatures to use as measures for a study. Well worth checking out.

[HappyPoet]

.

As i peruse this I want to know what things are most valuable to you.

Mental health
.

[ozarkcanoer]

Addressing what CCSVI is and what MS is : Fatigue has never been explained by the autoimmune theory. How could such a global symptom be related to local lesions ? Numbness can and tremors and optic neuritis can. But fatigue ???? CCSVI seems like a likely candidate for fatigue !!! Not enough oxygen in the brain lead to fatigue !! Jeff Beal and many others have relief from fatigue with the liberation procedure. Oh, and the same goes for headaches !

ozarkcanoer

[drbart]

how can i explain these abrupt changes.? we can all guess cant we. perhaps myelin transmission needs certain amount of blood flow,oxygen pressure reduction, cleansing for improved function. Your guess is as good as mine at this point. Like i keep saying we are just beginning an age of discovery.

do you see a pattern that would lead you to expectations about abrupt improvements? the easy things to imagine would be type of MS, length of disease, etc.

i'm wondering though about the importance of "little veins", ones that MR can't images at 1.2mm and you can't get at with a catheter.

is there enough of a pattern of brain/spinal lesions that would lead you to expect things more specific than spinal -> azygos?

the correlation between CCSVI and MS seems so high, that it might be the people who don't see dramatic changes are the most interesting cases. they may have just as serious an issue with blockage, but at a finer grain.

[Cece]

how about this: are you planning on directly measuring oxygenation levels? Or has Dr. Zamboni done this?

Here is what I'm finding:

Intravascular Jugular Bulb Venous Oxygen Saturation
Another method of measuring cerebral oxygenation, jugular venous oxygen saturation (SjO2) monitoring, has been used since the 1980s. Considerable research has been conducted with the SjO2 monitoring system. Monitoring of SjO2 involves use of a fiber-optic catheter, typically 5.5 french in size, placed retrograde in one of the internal jugular (IJ) veins (Fig. 5). It is tunneled up the IJ vein against blood flow toward the brain. The catheter is placed so the tip of the catheter is level with the mastoid air cells or approximately at the jugular bulb of the IJ vein (Coplin et al., 1998; Feldman & Robertson, 1997). The fiber-optic catheter measures the oxygen saturation of hemoglobin as it exits the cerebral circulation in the IJ vein and provides a continuous reading of venous oxygen saturation.

The SjO2 monitoring approach has been fairly well studied. The normal range of SjO2, confirmed in a study of healthy young men, is 55%-71% (Feldman & Robertson, 1997). Most users establish the normal SjO2 range at 55%-75%. Lower SjO2 is a cause for concern; a value below 55% reflects a state of ischemia in which oxygen delivery is compromised or oxygen consumption exceeds the supply of oxygen delivered to the brain. The low state must be treated promptly to avoid poor outcome (Nemani & Manley, 2004)

http://www.medscape.com/viewarticle/551323_6

Part of the theory is that reflux is causing low oxygenation, but if this can be quantified, I would consider that powerful evidence. I am thinking measurements pre- and post-ballooning.