This Is MS Multiple Sclerosis Community: Knowledge & Support

right dr sclafani. no need even for a control group if all you are doing is establishing safety. just assume you have a placebo group and they all stayed perfectly safe.

i think no treatment works just fine if you are allowing MS drugs in the control group. i was just thinking if you allowed swapping controls those people wouldn't have to wait the whole 2 years. of course you'll have a growing number in the treatment group but it will be a long time before you run out of controls, especially if they are promised they'll be allowed to enter the treatment group as soon as you have a good match for them, to replace them as controls.

usually there is an attempt to fool the no-treatment group into thinking they have been treated, to eliminate the possibility that the treatment has been a magic/psychological cure. But if you are really sure of the reality of your treatment effect, the difference between it and no treatment should be of a magnitude not explainable by placebo. I don't know what that magic number is, but i am confident it will be far exceeded, and indefinitely.

I think it is necessary to be honest with ourselves and nail down those numeric thresholds ahead of time. We should even make public what they are, or at least keep them in a mayonnaise jar on Funk & Wagnell's porch, if that isn't too obscure by now.

Like I said, if it persists over two years, you will have given that person a cure somehow anyway, and maybe we are just a bunch of whiners who can be cured by just spending money. I don't think so. Especially us SPMS and PPMS types who don't have any remissions.

After a few years of no remissions, two seems like the rest of your life. Sometimes it is. That's why those high EDSS and fast progressing ones need emergency rescue. That's why there's going to be an emergency debate in our House of Commons.

_________________
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'_MS' is over - if you want it
Patients sans/without patience

What about start mapping now to show the effect of seasons? It may be some time before treatment is available for all. The design of such 'tools' (tests) needs to be progressed as it will be the key tool in the future! Sadly Neuros have been the link to such testing and what do we have to work with so far?

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?

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?

I so appreciate your openness among so many other things.

':roll:')

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.

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.”
-

_________________
Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS or MS symptoms except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)

1eye, I get it now, that's brilliant.

That sounds like a nightmare.

Besides all the confounding factors you listed, there's the one Wheelchair Kamikaze has raised: a not unsizeable number of people diagnosed with MS are actually misdiagnosed.

Okay, a couple of thousand is very good, for starters.

_________________
"However, the truth in science ultimately emerges, although sometimes it takes a very long time," Arthur Silverstein, Autoimmunity: A History of the Early Struggle for Recognition

Thank you euphoniaa you have said more directly what I have been skirting around in my posts.
I have been officially diagnosed with MS, the last neuro has labeled 'mild MS', which he regrets as he sees my symptoms are debilitating and stopping me from working. I can walk, though not fast or with good balance. If I test my walking distance in total in one go the next few days the distance will be much much less as my body will need to recover, which varies in recovery time due to things like day time heat /humidity, stress, and my other symptoms overall effecting me, eyesight and TN and headaches and cog fog and bladder etc. The general symptoms seem to be interrelated and separately they can increase or decrease on their own.
On no two days can I say that I could track any symptom that would show the cause of the waxing and waning of the disease. I have tried keeping tracks on the symptoms listed above and they are not predictable in a way that can measured by someone on the outside, that is to say they are my impression of their effect on my quality of life.
I have been told by the most recent Neuro that I am most likely to be PP as I have not had any relapses in the 4 years that I have been regularly seeing Neuro's and I have progressed. My disease history is at least ten years to date and probably longer given the issues I have had over time.
My most debilitating symptom at the moment is trigeminal neuralgia which has been developing over a 3.5 year period and it is only in the last few weeks that my Doctor took the courage to say that is what it is as the pain has now reached the suicidal level and that can be 'seen' by observers.
Most symptoms that I have been going to my doctor, neurologists,MS Neurologist,neurophschologists and a host of other test providers eg MRI, VEP, SSEP, Lumbar Punch,Opthamologists,Optometrists,Dentists,Osteopaths,Chiropractors,Physiotherapists,ME/FM Specialists,Musculoskeletal Specialist, in particular are not measurable and repeatable. The evidence used to diagnose what is wrong with me came down to changes in MRI, elevated proteins in CFS, slow nerve transmission in RH eye on VEP. Which in essence could be thrown out. The changes in the clinic assessment had been the clincher and yet the neurologists have each had different responses each visit which has made them nervous of putting a label on me. If I was in a wheel chair I would have met their 'gold standard'.
To me this high lights how near impossible it will be to create a 'gold standard' set of tests for the trials for CCSVI.
People with RRMS are people who can benefit from the treatment and show results on the 'operating table' but in reality is that scientifically measurable to show the cause of improvement.
People with PPMS have what I call a more difficult form of disease because time is a BIG factor in the healing/improvement faze of the treatment process.
People with BegninMS are likely to benefit the most from treatment as damage to the CNS has not progressed to unrepairable or non improvable.
People with SPMS are in the group with PPMS I believe.
How the other subgroups fit in/ who knows?

The bottom line I have come to is that there are no tests currently available or used that can provide scientific proof the outcomes of CCSVI treatment (of any form) either link CCSVI with MS or that one or other is a cause of the other, because of the fluctuating nature of MS and its progression.
This is I think what has frustrated myself and others when we are wanting diagnosis, treatment/management options and most of all to be believed and heard when we speak of our predicament.
And what makes it harder to accept is that naysayers and Neurologists are using this fact. Other DMDs have been approved and the science has had to be spin doctored to get approval to make money, when we have to fight for credibility on relative low cost service to provide quality of life for the long term without ongoing profitability!
Thanks for listening.
So lets design some tests!!!!!!!!!!!!!!!!

Another thought; if no two people have the same symptoms and progression isn't it more feasible that CCSVI is the 'disease' because it is more variable in its observable 'dysfunctions'.
These dysfunctions appear to me to be attributable to disability. For example the iron build up and volume as one concept, would be different in each person and therefore it is more understandable how it will effect parts of the body function. For example the possible effects on the known processes of the thalamus that iron may have are more believable as a primary cause of the physical symptoms that develop. So many of my 'MS' symptoms have process links to the thalamus function for the body.
I am of the opinion that CCSVI is the base problem and long term iron build up is the cause of the symptoms, for some it is early onset and others later in life and the position and effect of the 'blockage' is dictating the time frame. Thrown in diet and other environmental inputs and you have an unpredictable varying process.

So the test for MS suffers that may be measurable? Iron deposits? Position of damage within the brain that has not yet been seen or attributed because the link to blood flow has not been studied? Flow measurement within the brain to identify deficits and areas of interest?
Sorry TN overload, keep thinking.

Yet another thought, whilst doing the safety work for the IRB, obverse the changes on the theatre table, design a way to measure what has changed in the process of the treatment that causes the observable differences.
Colour changes, temperature changes, balance, walking, cognitive, bladder and others.
The time during the IRB work can be productive in measuring benefit as well as safety, tolerance and method. Learn about the ways blockages occur at the same time learning about the measurable outcomes that can be used as evidence for continuing to provide treatment globally.

Hello again:

wrt euphoniaa:



You may be very unusual. A long, long,mild case that hasn't converted after 30 years (or have you?). Certainly I lost the cooperation of my doctors at just the wrong time. I was ripe for the nocebo effect to affect me, but it was a real attack and eventually I was not only SPMS, but unable to walk, drive, play guitar or piano, or work at my job, which required a lot of cognition. Fortunately I can still think and type.

But it sounds as if you are still doing fairly well, and can wait a year or two. You are walking, working, and probably driving. Contribute, I have been there, done that. I just want my veins dilated. I just found out Montreal won't give me the MRV because of metal stents in my chest. So I am going there, but only getting a Doppler ultrasound. I was one of the ones who had had an appointment made before they were shut down.

I guess they must have a strong MRI machine. Oh, well, I have had enough Gadolinium to last me.

It didn't seem possible that it could happen to me. I was certainly hard to convince, but after enough falls, I got the picture. Three things contribute to my falls. Lack of proprioception, spasticity, and no balance. Fatigue would if I could walk. That's like somebody I knew who was only 20 or so and had PPMS. She said she never sweated anymore, because she didn't have the energy. I wasn't that bad yet. Sensitivity to heat is nearly universal. If you don't have it, you probably don't have involvement of your thermometer. Hope you never get there.

When I was in rehab I was the mild case. Now I have a hard time dressing myself too.



Heart disease count? Anyway my father had what doctors called peripheral neuropathy, and I suspect he may have also had CCSVI. Will never know.

Definitely the variety of vascular issues. I have no problem distinguishing my CCSVI/'MS' symptoms from anything else even though I am somewhat cognitively challenged sometimes. When I have angina, I know it is not my MS (although nitro gives me headache).



Just look at a list of typical 'MS' symptoms



ditto



ditto



I'm not on any DMDs, and I'm on a soup, but doctors and pharmcologists have agreed there should be no problem, unless I take things like modafinil at the wrong time of day, and can't sleep. Heart patients have their own soup. I'm used to it, and none of them affect my MS symptoms in a bad way. Drugs that do, I avoid. I can give you examples, if you're curious.


So how do *you* quantify it? Is it measureable? How? In my books, it's still voodoo/junk science. I've been on it for 2 years, and not subject to either it, or nocebo. Just disease progression. People know when stuff works. Especially venoplasty.


Neurologists all spent about 10-20 years in the old school. I don't think we should try to re-invent their area of expertise. These versions are used because they *are* useful, over a broad range of patients. Maybe they don't know all the causes yet, but they've been studying 'MS' for a long time. 'MS', shlemess, it is still the same disease, in spite of CCSVI.



These tests are not meant to be repeated every day. If my EDSS were measured every day I might be slightly higher or lower, but usually in the same ballpark. I use a wheelchair to avoid falls, but I can still limp along with my walker. I have read the EEDSS, and I would categorize my progress differently: Walking, walking with fatigue, cane sometimes, cane all the time, walker sometimes, walker all the time, wheelchair sometimes, wheelchair all the time, and I know what the next few and the last one are and I don't want to talk about it.



It is very common, and includes muscle fatigue, as well as the complete lack of energy so reminiscent of fatigue syndrome that some are misdiagnosed. So common, in fact that there must be few who can claim that it is not a problem.



I agree. Before I got diagnosed (by MRI) I got a bunch of those. Some so primitive that as an electronics technologist, I thought I had time-warped at least 50 years. Didn't do a *thing* for my diagnosis. But fear not. Nerves do rebuild, although they must be among the slowest type of tissue.



no DMDs



You may be some kind of outlier. I'd let you in my trial, but only if you behaved yourself. I might have to throw out your data points.You may be some kind of outlier. I'd let you in my trial, but only if you behaved yourself. I might have to throw out your data points

_________________
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'_MS' is over - if you want it
Patients sans/without patience

An MS newsletter I get was all about measures of MS disease that might be used for trials to asses MS disease:

progressiona: http://www.ncbi.nlm.nih.gov/pubmed/20437181

meaningful measure of disability: http://www.ncbi.nlm.nih.gov/pubmed/20421572

Health related Quality of Life: http://www.ncbi.nlm.nih.gov/pubmed/20421570

All could be used, and if any were was statistically significant you could claim the treatment was justified.

There have recently been twin studies published (one with and one without MS) that concluded that there were no major genetic differences between the two. I'd love to see twin studies regarding CCSVI.

Yes, L, I have always been wondering about that. If in childhood of identical twins similarities in CCSVI (as regards type of vein problematic/location) would be found, this would confirm the congenital issue.

And if one identical twin then develops MS, the other not (and there are such cases) wouldn't this confirm that MS is still multifactorial, as additional environmental or other factors must have played an additional role on top of CCSVI to then develop MS.
And isn't it then strange that the other twin would also have CCSVI, but did not develop MS, as regards the strong link that has been found between MS and CCSVI? So he would have a genetic predisposition to develop MS, but did not develop it for whatever other environmental reasons...

The people that are most important to the discussion on trails and what can be proven are very quiet.
Can we please have some input from those that have been treated!

And there's always the possibility that one twin has CCSVI and the other does not..

Hi NZer1,
If I could be of help (as a newly liberated MSer) in this thread I'd be happy to do so, but the thought of having to read 79 pages just to get up to speed is more than a little daunting. Also, since I haven't had any remarkable changes in the 12 days since liberation, I couldn't add much that you couldn't get from the tracking thread. The only thing that (I'm hoping) might be of use in the future is that a) I've been going to the gym regularly so can notice quite accurately when things change (such as the improvement in the strength of my left arm I noticed last week) and b) my physiotherapist did a bunch of benchmark tests on me before I went to Poland.
...Ted

_________________
Dx SPMS in 2004.  Liberated 29/04/2010.
My blog: www.my-darn-ms.blogspot.com