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Symptoms I would like to see go away

Posted: Thu May 13, 2010 6:52 pm
by bmk1234
I fall into the category of you would never guess I had MS.

The symptoms I would like to see go away are all in my head:
I've had a headache every day for 8 years.
Memory is not good.
Get confused easily.
Problem solving issues.

I would think for the cognitive issues you could design a test that would be able to measure your cognitive abilities pre and post surgery.

Posted: Thu May 13, 2010 6:54 pm
by drsclafani
drbart wrote: speaking of dollars, how about working that angle and getting some entities involved whose vested interests are on the other side of the equation from pharma and neuro?

insurance companies are paying out big bucks for MS drugs now, and we know from the co-pay coupon thing that they can be natural adversaries of pharma.

how about this for a study? instead of looking for incontrovertible evidence of CCSVI/MS linkage, let's do a massive, distributed study of the one thing we care most about (well, second-most).

take half the $25K/year/person now spent on MS drugs, and use it to pay for catheter venography for any MSer who signs up. the study would be about the need for MS drugs post-liberation, and participants would stand a 50% chance of getting a placebo of their current MS drug (i trust they make avonex placebos that give you flu-like symptoms?).

what fraction of MS patients would *not* sign up for this?

the study could be huge, with the issues being mainly of scale. 1) you have plenty of patients and can get really accurate stats. 2) you have to train a whole bunch of doctors and their technicians in diagnostic and treatment techniques. 3) you'd have to make sure re-stenosed patients get re-opened right away.

insurance companies should love this, and there would be a huge pool of pre- and post-liberation MS patients available for all kinds of neuro studies.

would dr sclafani be up for spending a lot of his time training other doctors?
I am doing that most of the time. It is a university you know and we train leaders. some will become teachers. Seminars will be the first step.

I will be putting one on in July. I will let you all know more about it when plans are firmer

Posted: Thu May 13, 2010 6:56 pm
by drsclafani
drbart wrote: speaking of dollars, how about working that angle and getting some entities involved whose vested interests are on the other side of the equation from pharma and neuro?

insurance companies are paying out big bucks for MS drugs now, and we know from the co-pay coupon thing that they can be natural adversaries of pharma.

how about this for a study? instead of looking for incontrovertible evidence of CCSVI/MS linkage, let's do a massive, distributed study of the one thing we care most about (well, second-most).

take half the $25K/year/person now spent on MS drugs, and use it to pay for catheter venography for any MSer who signs up. the study would be about the need for MS drugs post-liberation, and participants would stand a 50% chance of getting a placebo of their current MS drug (i trust they make avonex placebos that give you flu-like symptoms?).

the study could be huge, with the issues being mainly of scale. 1) you have plenty of patients and can get really accurate stats. 2) you have to train a whole bunch of doctors and their technicians in diagnostic and treatment techniques. 3) you'd have to make sure re-stenosed patients get re-opened right away.

insurance companies should love this, and there would be a huge pool of pre- and post-liberation MS patients available for all kinds of neuro studies.
I would doubt that insurers will not pay for something that is not shown to be safe. so drbart hold onto your ideas. there time will come

Re: black arts and sciences

Posted: Thu May 13, 2010 7:04 pm
by drsclafani
Cece wrote: It might seem from this forum that every person with MS is hugely informed about CCSVI, but that probably doesn't hold up out in the general MS population. Maybe you would need a questionnaire before you started your trial that would ascertain the level of knowledge the person had about the treatment of CCSVI. (If they know about ballooning, they don't get selected.) Also if there are any out there I would choose subjects who did not have internet in their homes over those who do, for obvious reasons.

I am still against a trial like this taking two years...six months seems more acceptable, but would results show in that amount of time?

What do you think? Ethical?
it would be unethical to plan the study around maintaining patient lack of knowledge. you cannot take a vulnerable population and do an experiment on them.

Re: placebo and control

Posted: Thu May 13, 2010 7:20 pm
by drsclafani
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.
I like this idea a lot. My waiting list has sufficient patients to do this now. however, how would i do that humanely. treat the first 200 patients and let those lower down the list be the controls? Do this by lottery? Stratify by type of MS? lots of options

but i do not like to play solomon, only saltheman

how would you do it?
You don't even need to use the same people as controls all the way through, you can select another control and treat the previous one. As long as the number of controls (plus maybe sex and age) stays the same. I don't even think their MS status matters, but keep them all the same if you want.
I dont agree. the controls need to be untreated long enough to make a difference. time does matter.
]

Posted: Thu May 13, 2010 7:32 pm
by Jason
Dr. Sclafani
Many of us will be travelling with family or a helper that does not have MS, so while we are being Liberated they could be scanned as your control group.
Just a thought.

Re: placebo and control

Posted: Thu May 13, 2010 7:35 pm
by drsclafani
Cece wrote:
1eye wrote:
After all, we have been quite vocal about the fact that we are not treating MS.
Let's get that one out of the way first. You are so.
Somewhere in the last 77 pages, I remember Dr. Sclafani saying that we couldn't be coy about that we were treating MS because we quite obviously were, and that was why all studies had to have a neurologist partner and keep track of all MS symptoms...although he is allowed to change his mind whenever he wants, although preferably not about appointment dates ever again. :)
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?

Posted: Thu May 13, 2010 7:40 pm
by drsclafani
Jason wrote:Dr. Sclafani
Many of us will be travelling with family or a helper that does not have MS, so while we are being Liberated they could be scanned as your control group.
Just a thought.
jason

80+ pages has been a very long road to travel. I cant even remember all the conversation. perhaps you havent been on it for the entire journey but i say that the scanning is moot to me. I am more into the liberation. we are talking about controls of treatment not trying to valiidate the idea that MS is associated with CCSVI

Re: scanning question?

Posted: Thu May 13, 2010 7:51 pm
by drsclafani
rettahb wrote:I've been contacted by the Buffalo study. Do you think it will it be beneficial for me to participate? One thing the contract says is "I understand that the only benefit I will receive from these Tests is the knowledge that I present (or do not present) CCSVI." and then,"Thus, any information you gain from these Tests is purely informational and educational and will not be able to be used by you or any other person to diagnose, cure,treat, mitigate, or prevent your MS." And I don't see any mention of "Venography" the "gold standard." Is it worth the $4500? I am on Dr. Scliafani's wating list and more then anything hope that his study will come through as well. Any input would be appreciated. thx.~r
if you have insurance, you should be able to get that testing for less. my hospitals cash price is about twice that for liberation and testing
i would hold off

Posted: Thu May 13, 2010 8:07 pm
by thirdday
Nunzio wrote: Going back to Thirdday question the only problem I see is the presence of reflux.
Usually that indicate a blockage below the area where the reflux was noted.
If the occlusion was a thin membrane is possible that passing the catheter was enough to open it up.
Have they repeated the doppler after the venogram?
No, they did not repeat the doppler. Because of a situation that was beyond our control, the doppler was done by one doctor, but the venogram was done by another doctor. I'm concerned that something may have been missed in the venogram. Perhaps we may need to wait for more research to come and for some doctors to get IRB approval. Then my wife can get retested by a doctor that has more experience with CCSVI.

Posted: Thu May 13, 2010 8:20 pm
by drsclafani
mrhodes40 wrote:cece wrote
I would propose a venogram for the control group and endovascular treatment for the treatment group.
Forgive me for butting in here but would this not result in some "treatment" in the control group?

IF a control had a membranous obstruction could it not "accidentally" be corrected by venogram alone and would this be enough to confound the results?

Are you seeing any of these membranous issues?
marie
yes. they are very difficult to identify unless they are very thick. I see them as just another malformed valve. you are correct, they can be lifted out of the way by the catheter but tend to fall back like the lid on a garbage can

Posted: Thu May 13, 2010 8:23 pm
by drsclafani
1eye wrote:i don't know. make it a 2 year trial?
that about right

Posted: Thu May 13, 2010 8:31 pm
by drsclafani
simone wrote:
Dear Dr S

Keeping it simple and replicating Dr Zamboni's studies, seems like that would do well for now. What are the missing pieces for the set up?
And will you have other docs watching and learning at your side? Will other docs be doing the procedure? 200 -300 patients?
my ptotocol calls for me to perform all 200 patients in the safety study. I will have assistants to teach but i will do the first 200 cases.
There seems to be a problem with ballooning holding even for a short time, can that be improved with experience or are some vein's formation just too difficult to have it be effective? Some veins are seen on MRV as very squigglely and seem to not respond to balloon. What tests will you use? Will you have to see beforehand, before you get your hands into it?
one of the things we have to decipher is to learn which findings predict recurrence. and which will require stents up front because they are likely to fail.

the tests i rely upon are catheter venography and intravascular ultrasound

Posted: Thu May 13, 2010 8:46 pm
by drsclafani
euphoniaa wrote:Hi Dr. Sclafani, this thread is great! I can't tell you how much I appreciate it. Besides the obvious reasons – the great CCSVI info, keeping us in the CCSVI research loop, treating us like we're capable, thinking adults - it's also reassured those of us who have had less than satisfactory doctor experiences that you guys really are working for our benefit. This is so refreshing! Thank you very much.

After living through 35+ years of MS crap, I truly am a patient patient. I'm excited to be on your list, to be part of the "age of discovery," and to have the opportunity to contribute, no matter how long into the faraway future. I only hope it's my turn before I hit your upper age limit. :D

I have a few rambling comments about those “confounding research variables" you mentioned and about the limitations of the current MS tests. I’m sure you’ve noticed that many (most? all?) of us have more than one serious, symptom-producing medical condition to contend with besides MS. I've always suspected that the uniqueness of every MS patient was due more to our different combinations of medical woes than from MS alone. Now I suspect an additional element – our individual vascular problems contribute and are just as varied.

I think the biggest research challenges to evaluate treatment results will be to figure out:

**Which symptoms relate so directly to CCSVI that they can be tracked before/after treatment

**Which symptoms are due instead to the eventual MS results of vascular issues (like lesions in specific CNS areas) that will take longer to heal

**Which symptoms are due entirely to our other medical conditions and do NOT relate to CCSVI/MS (like many of mine)

**Which symptoms are due to side effects of the meds/supplements taken - or "medicine soup" as one of my docs called it

And, as you mentioned (and with sincere apologies to 1eye :) ):

**The placebo "effect" (not to be confused with placebo treatment). No matter how much we’d like to think we’d be less affected by it, the placebo effect is so universal and well-documented throughout the medical world, why would it spare only MS patients? And I've become intrigued by the "Nocebo Effect" as well, suspecting both of them have influenced my own experience with MS. Here's my thread on that: http://www.thisisms.com/ftopict-8567-.html

MS surveys/assessments: I've been reading tons of suggestions here about how to evaluate us with all the usual old MS surveys & tests, but it seems to me that CCSVI research will have to develop its own unique scales from the new perspective - specific enough to identify previously unrecognized symptoms, but broad enough to encompass all the usual MS suspects. The "old school" versions have never been very helpful before, so why should they suddenly be more accurate now?

I've been researching my own self (charting my symptoms daily) for several years, ever since my experiment with LDN, so I know my body's quirks pretty well and I’ve developed my own ways to rate them. I have about 35 columns with room to note unusual incidents or changes, from walking to mood. The most surprising (and reassuring) discovery I made is that the squares are mostly blank - I don’t have many symptoms "all the time" like it seemed, and the symptoms are often dependent on my outside environment. I've learned a lot about my health that way.

However, I'm currently in the midst of an IRB approved MS fatigue study at my place of employment, and, unlike my own charts, the commonly used scales they give me for the studies are of limited value even for evaluating MS, let alone CCSVI. They seem outdated, inadequate, non-specific, and sometimes silly. They generalize and assume too much stereotypical info about us, leaving no room for exceptions, and most end with a total score adding widely varying variables. For example, I have dozens of measurable MS issues, but fatigue is NOT a problem with me. The FSS assumes that it's a huge one, and leaves no room to note otherwise. I got a negative number on the FSS, and I couldn't even muster up a teensy grimace on that old standby that accompanied it, the precisely calibrated Frowny Face Scale. :)

The generic MS scales (MSQOL, EDSS, MSIS) are just as limiting:
Example:
Last week I was hobbling around my office in pain - both my hip joint (arthritis) and knee (degenerative joint disease) went nuts. This is not an MS thing – it's not even on my MS side – and I've figured out what I did to cause it. In the meantime, I always wake up and go with whichever body parts are working the best that day anyway, so I still climbed the stairs using my MS leg (it was working fine), one step at a time. My co-worker gave me pitying looks like I'd finally been hit with the Big One they’ve all been expecting and suggested I call my neuro right away, even after I explained that I had a literal pain in my butt and NOT in my head.

But...the MSQOL and the EDSS don't differentiate between MS and other health issues and the MSIS is similar. The MSQOL assumes that MS is the single most overriding health/emotional issue in your life and all else pales by comparison, even though the questions never specifically refer to "MS" at all. However, this leg thing would have tanked my total scores on all the scales, due to a temporary, non-MS technicality.

Electrophysiological Data (Oh nooooooo...):
I'd be glad to do any tests that would add to the CCSVI database, but I'd rather avoid these. The one symptom that has remained constant since my dx - and the one that seems most "MS-y" at first glance - is probably not from MS at all, and is more likely a PNS issue: popcorn twitches under the skin in my entire left leg & foot, 24/7. They first appeared after hours of needles and electric shocks (EMGs and SSEPs) that, I suspect, may have fried my fragile, demyelinating, peripheral nerves, damaging them permanently.

After one lab did EMGs over and over at different temps on my arms & legs, I was sent to another lab for evoked potentials. They got such abnormal readings on my left leg that they did the SSEPs over and over, with 4 types of electrodes and then the "cattle prod" as they jokingly called it. Ha. It took 2 techs to hold down my leg during their final assault on it, because of the nerve spasms.

And I already had a definite dx of MS & HNPP before then. It’s doubtful these twitches will disappear for me by opening my jugular, although it might for others.

Big Point – our additional medical problems and meds could skew the data as easily as anything else. I think it's likely that even successful CCSVI treatment may be obscured by our other issues – maybe even more than the placebo effect could show a too positive impression of the results.

Thank you again, Dr. S. I have complete confidence that you and your team are capable of accomplishing your objectives even without our advice, and that your open minds will be able to adapt to unforeseen events.

As for the thread’s many other suggestions and ‘tests’ for CCSVI recovery, I hope you and your team keep an open mind about them, too...

**I DO have a definite dx of MS - I pass ALL the tests.
**I do NOT have excessive fatigue.
**I do NOT have an exceptionally low tolerance for heat.
**I do NOT have unusually cold hands and feet.
**I do NOT have exacerbations.
**My lesions didn't change or enhance between my 3 sets of MRIs.
**My numbness comes & goes almost solely due to HNPP and its quaintly named “Pressure Palsies.”
-
Thank you, that was enlighteing

Re: placebo and control

Posted: Thu May 13, 2010 8:50 pm
by pklittle
drsclafani wrote: 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?
AMEN Doctor!