DrSclafani answers some questions

[fogdweller]

The one symptom that many MSers say is their worst symptom is FATIGUE. I have read a lot of anecdotal reports here that say after liberation the fatigue goes away, the cog-fog is gone, minds go from low-def to hi-def. Surely there can be some way to measure this. Some sort of a neuropsych test ? When I go to BNAC one of the tests they will give me besides all of the imaging (doppler, MRI, MRV) is a 2 hour neuropsych test.

So if fatigue is many MSers worst symptom, then measure fatigue pre and post procedure.

ozarkcanoer

When I first went on disability my insruance co. had me go through an entire day of phychological tests that they claimed measured mental abilities and highlighted problem areas in great detail and could not be faked. Plus there are a lot of post stroke tests that are done.

[NZer1]

Fog, I have started the post below and I agree with the direction your thinking is taking you, lets get the list working for us. I think as the list grows it will direct our thinking better and clearer.

http://www.thisisms.com/ftopic-11677-0- ... rasc-.html

[Cece]

ok anyone who is tired of reading about placebo trials, just skip over this post...

To build on my earlier idea about the venogram as the placebo group, the trial could be designed so that the patients were told that it was a trial of different methods of treating CCSVI: angioplasty with stents, angioplasty alone, "hyblation", and no treatment. Only there doesn't have to be a real no treatment group and the "hyblation" is the hocus-pocus with pretending to hyblate the stenosis during the venogram.

Compared to my original idea, this acknowledges that ballooning and stenting are two methods but introduces the fake hyblation as a third, just one of the many, nothing to worry about here.

[NZer1]

Cece, I think that we don't have to concern ourselves with the possibility of Placebo, its for the naysayer, Freedman types to prove. I don't think we have to worry about it at all, the naysayers will do it for us at their expense. We know it is not a issue!!!!!!!!!!!!!!

[Cece]

I hear you, Nzer...I am thinking that a well-designed, randomized trial with a placebo component would be the quickest way to mass acceptance of the need to treat all MSers for CCSVI...I am so impatient with the pace of all of this.

[NZer1]

I hear you too. I think that we have to keep in mind that PLACEBO is about proof for large hungry profit making blood sucking lairs to make people believe their life savings and government funding should be pipe lined into their coffers! Get my drift?

[drsclafani]

Even small improvements could be enough to be statistically significant.

there is statistically significant and there is patient significant.

we need to identify the improvements that patients value. then determine whether they are reduced in a statistically significant number of patients.
As i peruse this I want to know what things are most valuable to you.

i am not interested in focusing on one symptomatic improvement but on all of them. We need to find out which are improved.

[1eye]

I would like to not be dizzy. I would like my intention tremor to go away. I would like less spasticity. And I would like numbness to go and strength to return. And more proprioception. And a train and a slinky.

[drsclafani]

The money used in research needs to be directed by people wanting knowledge on cause not profits into the future.
It is sad that the work of so many learned and caring Dr's (BIG plug for our favourite Dr. S ) have been hamstrung by the lack of foresight of the research profession.
There needs to be a BIG change in knowledge about our disease happening in parallel to the work of these brilliant crusaders who have made the stand to further our options.
I'll fall off my soap box now as my TN is killing me!
Enjoy your day.

what does TN mean? trigeminal neuritis?

[newlywed4ever]

What symptoms would I like GONE...oh, Lord, let me count the ways!
No more fatique
No more foot drop
No more dizzyness/balance issues
No more cog fog
No more over-active bladder
No more cold feet/heavy feet
No more spasticity
No more lack of sleep
No more lack of libido (too much info?)
No more heat intolerance
No more disease progression
No more waiting for IRB approval!!

[drsclafani]

Dear Dr. Sclaffani,

Upon suggestion of member of this forum I am daring to ask you directly:

The more I look at my Doppler, the more suspicious it seems.

I know "they" looked and said it was normal, I still have some questions.

How come my Left Proximal Jugular looks of equal width along whatever distance the image was taken, but the other two images show distinct narrowing. I mean, if the widest part of my Left Distal Jugular image is 5.7mm, what does it make the "skinny" part? About 3mm?

All the while my Right Proximal Jugular is a whooping 22.5mm in the widest part, though looks much skinnier on the other side?

Or is this just the way they do imaging and I am not interpreting it right?

Equal:


Skinny part ~ 3mm?


The fat right one


Thank you in advance!

This is difficult to explain and I am not saying that i agree of the diagnosis. In order to do that you must see all the images. Because the transducer of the ultrasound probe must be parallel to the structure, it is possible that because the vein meanders that some of the vein may not be seen in profile
That is why ultrasound is so operator dependent. while an mri, mrv, ct ctv all are completely reproducible but not ultrasound

[Cece]

And a train and a slinky.

Hee. A barbie dream house, for me.

Here goes, in order of importance: no more chronic fatigue, no more cog fog and memory lapses, no more heat intolerance, no more foot drop.

I talk about this as if it's possible, because with CCSVI treatment it maybe is, but six months ago I'd have never thought to ask for any of it.

[drsclafani]

Dear Dr. Sclafani,

Thank you for your reply - and most especially your assurance that you and your team will figure out how to address compassionate therapies for these patients who cannot be included in the trial.

Please let me know in a "PM" if you are aware of any such studies already started or on the verge of being started - on how to help this group of patients with CCSVI? Any more information that you can provide me with for these patients would be very, very much appreciated. As you are well aware, time - sadly, is of the essence.

I am unaware of any studies that focus on the most disabled.

My protocol addresses this question. It states the inclusion criteria and then states that such patients would be treated on a compassionate basis outside of the protocol. If the protocol is accepted, such patients are considered. i hope it works and thanks for the concern

[drsclafani]

as i suggested to colleagues, we need a comparaitive intent to treat study. each diagnostic test would be described. each of several investigators would read the evaluation of the test and make a treatment plan based upon that imaging. Then the group would convene to look at all of the imaging and come to consensus of intent to treat. Then compare the results of each test by each proceduralist to the consensus.

Were your colleagues receptive?

yes, we shall see what actually happens

[girlgeek33]

as i suggested to colleagues, we need a comparaitive intent to treat study. each diagnostic test would be described. each of several investigators would read the evaluation of the test and make a treatment plan based upon that imaging. Then the group would convene to look at all of the imaging and come to consensus of intent to treat. Then compare the results of each test by each proceduralist to the consensus.

Were your colleagues receptive?

yes, we shall see what actually happens

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