This Is MS Multiple Sclerosis Community: Knowledge & Support

As a grant writer, it seems to me that JK Rowling would be the right person (with deep pockets and a compassionate heart) to fund Dr. Sclafani's study. But I went to the link above, found that the charity she runs that funds MS Research is here:

http://www.volanttrust.com/

And then found that she is not considering MS related applications "for the foreseeable future." If we could just get her excited about the concept of CCSVI, perhaps that might change.

Here's the quote from the "Volant Charitable Trust" website:

Of course there are other foundations out there that might be willing to help fund the study. And direct fundraising of individual donations is another option to pursue.

Dr. Sclafani, I hope you will consider setting up a nonprofit entity to accept donations for your future CCSVI study. That would open up more avenues of support. Or perhaps the CCSVI Alliance could create a dedicated fund for accepting donations for your study. Since they are a 501(c)(3) nonprofit, this would accomplish the same thing.

Mary Ann

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DX 6-09 RRMS

Yes, we have discussed this before and i agree that it is likely to be difficult to completely blind all patients in a trial. Certainly patients will have to be deeply sedated, far more than I like to. As you know i need a conscious patient to help with all the manuevers i use. Nonetheless, this is what will put this to rest. nothing less will be accepted by neurologists and other physicians

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Salvatore JA Sclafani MD
Patient contact: ccsviliberation@gmail.com

Hi Dr. S

I have a question for you.

But first info
I am a Male, and have made 28 flights around our sun.
I am not diagnosed with ms, They tried to, but since there are no lesions in my brain, have no problems with my eyesight whatsoever, and still haven’t developed any handicaps. Apparently They can only diagnose people with visible brain damage, severe handicap or poor/no vision. I cannot be diagnosed, must wait till I meet the criteria. Guess that the diagnose would be PPMS with slow development. (it is 5 years since it started)
I describe my symptoms. Tired and heavy arms/legs, bad hearing on the left ear,
sensory disturbances, Muscle contractions, Annoying heart rhythm, mostly when lying on the left side + I feel when lying down on the left side that something is knocking in my neck. This knocking in my neck (as weird as it may sound ) Follows the annoying heart rhythm…
When going from sitting to upright position, sometimes I get headache. Feels like its located in the back of my head, and again this follows the heart rhythm.

I was in Germany for angioplasty last year. Internal jugulars left side 80-90% Closed. Right side 70 % closed. Got some sensation back and my heart rhythm felt better right after. But within days after the procedure, I felt a sudden heart race and the benefit was gone. ( I know restenose)

Here comes the big Question is it possible that all my symptoms are caused only by poor blood flow in my body, an to much/high blood pressure in my brain. = no lesions needed to get div. neurological symptoms.

Have you seen such a case before?


Greetings from Denmark.

I was sedated for my heart angioplasty with an IV line, and I think they gave me muchos valium. I did not sleep, and I was conscious enough to feel the guy poking his catheter down my artery into my leg. He went as far as my knee. I was not pleased, but what could I do?

For the procedure with Dr. Siskin, I was on valium, plus I might have still been feeling a nitrazepam I had taken the previous night for sleep. I slept through most of the procedure. I snored a long time later, apparently very loudly, before my wife came and poured me back to the hotel. I was pretty out of it, but I thought I could remember being asked to take a deep breath. You'd have to ask Dr. Siskin. I did not feel a thing. I know you use fentanyl, but believe it or not, "-azepams" work quite well because you might feel something, but you don't care. I do not do pain very well, and it was good enough for ballooning in both my neck and chest, with stent installation in my chest.

At the Heart Institute, I remember thinking, "I'm glad I can't feel this", when he was in my leg. Since the famous placebo effect is supposed to take place after the procedure, something that causes amnesia, without making you too asleep to take a deep breath, is probably necessary. Dr. Code should know. Hey, why not ask him to do the trial? I bet he would!

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

I am going to try to acheive the impossible and question your trial design Dr S and stay on polite terms with TiMS posters. I hope you will take my comments as thoughts from a critical friend.
I see a flaw in the first trial (my label A) as it assumes that CCSVI is unique to MS. If CCSVI occurs in other early stage (pre-diagnosis) neurovascular diseases then you could find stenoses in healthy controls. Also as MS is a multi-factorial disease there are likely to be pwMS who do not have stenoses. If either or both of these senarios occur then the main discussion (introduced by Neuros) will be that CCSVI is not the cause of MS.
Your second trial (my label B) is too small in size to be conclusive. The MS group has too many sub-groups in it to allow statistically valid data to be generated. New MS drug trials are very large in size in order to acheive statistical significance and many barely acheive this despite their large size. In the UK, the use of complete sedation to conduct Sham Trials would probably not gain ethical approval (NICE has not demanded sham trials in IPG420).
I am tending towards a '500 controlled case study' (then group findings) as the trial method most likely to succeed for CCSVI in pwMS. I see the main problem for IRs in such a study being that the same diagnosis and treatment regime must be used (no improvements during the trial) for all 500 case studies. That is not the way IRs work in my limited knowldge, IRs tweak the method as you use it.
So my question on your trial design is 'are you sure?'
Kind regards,
MarkW

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Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html

Then again, if enough people responded, some kind of significance would be attributed.

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

Hello Dr Sclafani,

I would like to ask you if there is any progress made for people with atresia/agenesis of the azygos.

If I understand correctly is Pattern D, based on Dr's Zamboni Protocol, and there is no good prognosis for this kind of situation.

Thank you for your time.

Mark, the question that was posed to me was 'what will it take to have ccsvi and its treatment accepted by neurologists"
in my opinion this is not the question that I would ask. I would do a trial, to look at symptomatic relief. But that is another story.

i also said i am ready to do a trial, but i dont have the money. The reason i am ready is that i believe that i have maximized my techniques. True there are nuances still left to study, but they are uncommon presentations and require uncommon techniques. These need to be trialed themselves. For example, does treating the C2 compression make a difference? how about the may thurner syndrome?

I would envision trials on efficacy of venoplasty for fatigue, imbalance, and other commonly improved symptoms. This make the most sense. But who had common sense on any of this stuff. As you say, trying to prove that ccsvi causes ms is not going to happen in my career.

with regard to sham trial, there is no other way to exclude placebo effect. The current trial of radiofrequency ablation of the renal sympathetic fibers for uncontrollable hypertension divides the groups in two... 2/3 of patient undergo arteriography and RFA and 1/3 undergo arteriography without RFA. After six months all those undergoing the sham operation may opt in for the procedure as well. No reason why we cannot do this for ccsvi except that no one will consent to this HIGH RISK POTENTIALLY LIFE THREATENING catheterization (sic) without having the use of the LIFE THREATENING angioplasty catheter.

I can see that you are understanding my frustrations after two years of this banter.

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Salvatore JA Sclafani MD
Patient contact: ccsviliberation@gmail.com

i havent experienced one patient with this presentation. Venous obstructions come in many varieties. it is difficult to make assessments and judgments based on such limited data as 80-90% stenosis.

But i do not focus on MS. I focus on CCSVI. MS is a diagnosis of exclusion. CCSVI is a diagnosis of discernible narrowings of the veins associated with reversal of flow above the valves. IT may have something to do with MS. I dont know

but if you have 70-90% stenoses, then those are real, objective findings and they are associated with real clinical symptoms. If treating the obstructions results in improvement of the symptoms, then all it proves is that angioplasty can improve symptoms. if treatment of those obstructions leads to no improvements, then there are only a few possible explanations.
1. the obstructions are not part of the cause of the symptoms
2. the treatment of the obstructions was not technically successful and thus no clinical improvement is sustained.
3. the obstruction is coincident with some other cause of the symptoms.

By the way, why anyone would have objections to treating obstructions of veins of the brain while allowing treatment of obstructions of the veins of the leg is beyond my comprehension.

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Salvatore JA Sclafani MD
Patient contact: ccsviliberation@gmail.com

Excellent points.

.[/quote]


The turf wars are worse now than ever and it's getting uglier by the day.

best
why do you say that. it is no uglier now than when i first got involved from my point of view. What has changed for the worse?

they still think its snake oil
americans still sit on this duffs, barely making a peep.
I still see more patients from athens than from new york city.

but we persevere, dont we

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Salvatore JA Sclafani MD
Patient contact: ccsviliberation@gmail.com

The FDA statement, which is very one-sided, makes me believe there's a bigger agenda than Dr. Mehta not having and IDE. The dr in CA who instigated it was targeting Dr. Arata. The Italian MS Society trying to sue Zamboni was ludacris. The backlash against CCSVI seems to be louder and there is disregard for any positive research.

CCSVI, as you've maintained, must be seen and treated as its own condition because it is.

yes those are rather annoying actions, but no worse than some of the other stuff last year
it is an uphill battle, isnt it.

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Salvatore JA Sclafani MD
Patient contact: ccsviliberation@gmail.com

It's ludicrous. Sorry. If it hadn't caused actual pain, I wouldn't have mentioned it. I feel better, now.