This Is MS Multiple Sclerosis Community: Knowledge & Support

It looks like there is going to be an official clinical trial of the angioplasty treatment for MS.

http://clinicaltrials.gov/ct2/show/NCT01089686?term=ccsvi&rank=1

They expect to have results in about 1 year. This is a pleasant and unexpected surprise.

But it raises a few questions for those of us who were planning to have it done soon. Should we go ahead and have it done now or should we wait until the clinical trials are done?

I've been thinking about the advantages/disadvantages either way.

Here are some of the advantages to waiting:

1) It should answer positively the question of whether Liberation is an effective treatment for MS before we go through the expense, risk, and difficulty of having it done.

2) If it becomes an accepted practive it should be available locally without the need to travel across the country or out of the country. That's a big advantage if follow-ups visits are required and for people who have difficulty traveling.

3) If it becomes an accepted practice it should be covered by health care insurance.

4) They may learn to improve the technique during the study.

Disadvantages to waiting:

1) You won't get it as fast. If your condition is rapidly declining that could be an issue.

2) They aren't including people with PPMS in the study so the question of wether it works for PPMS will remain unanswered by this study.

If you have other thoughts about the advantages of waiting vs having it now please list them.

I am changing fast so for me it's a no-brainer. Luckily I'm scheduled Sept 20th. The 19th will seem like christmas eve, gary

Great this new research. Mark mentioned it in his Wheelchair Kamikaze blog some days ago!
Looks a lot like the Buffalo trial, only, more people are involved (and more people 2/3 get really treated!)

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I'm ready, I'm ready !

I would be concerned that, for whatever reason, the trial does not show conclusive results, or that it shows there is no benefit over placebo. Maybe I'm being paranoid, but I would think that this could happen for a number of reasons other than the treatment didn't work in that study, such as, the particular endpoints recorded, under-treatment, etc.

If one trial doesn't work, it could add pressure to centers to stop treatment. I'm counting on the anecdotal reports of efficacy and the expertise of the IRs/vascular surgeons and trying to get treatment for my husband before things get murkier.

Oh yes Joge's comment reminds me; They are looking for volunteers to participate in the study. You have to be 18 to 55 years old, and have RRMS or SPMS. ( Apparently they don't want any geezers my age to participate )

2/3 of the participants will get the real treatment. 1/3 will get the placebo which in this case means they will do a venogram and will try to convince you that you got the treatment when you really didn't. In my opinion that part is a bit questionable from a moral standpoint, but I guess that's the only way to run a blind study.

INFORMED CONSENT covers a myriad of issues.

So many studies exclude those of us with PPMS, I would really like to know the thinking behind the decision. I am on the wait list for Albany but am on the fence about whether I would get any benefit from surgery.

If there is some evidence that PPMS will not be affected in a postive way I would rather take my time, energy and money and go to Disneyland or invest in a modified van, etc. I guess we have to wait for a year or 2 for liberated PPMSers to see if they are stable. However, every year I am less mobile and my left arm and hand is now a problem.

Will we ever know if PPMS can be helped if someone doesn't do a study? Does anyone know of anything in the works?

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Kathy, 49 with PPMS,full time scooter.
Married to a wonderful man, mother to a darling 9 yr old boy

Kate I share your concern about the lack of study on PPMS. In my case neither of my neuros could or would tell me what type of MS I have. I don't have relapses or remissions so that kind of rules out RRMS. Like you, I'm kind of on the fence about whether Liberation would help.

I agree with you.


The PPMS thing has to be looked at too. Those people should not be left out. The original study Zamboni did had a very small number of PPMS patients (10) we don't know the details behind their ms, as in how long they had suffered from ms, if they were mobile etc. We can only build a picture of what goes on with PPMS patients if people invest in studying them.

I get so angry when progressive ms is left out of any new research. These guys suffer all the time and don't get a 'break' ever.

David, my wife had the procedure done in April, here is my take on your questions:

1. Expense - it was 90% covered by our Blue Cross. I believe it was written up as a venous blockage.
Risk - True, there is a risk to every medical procedure, but the risk in CCSVI ballooning is almost nil. It is similar to what IR's do hundreds of times a year. Granted stents add a slightly higher risk, but you can insist on no stenting.
Difficulty - My wife was back home within 3 hours of having the procedure done. What difficulty?

2. We had the procedure done at our local hospital, 14 miles from home. The procedure is now being done by many IR's throughout the country.

3. As I mentioned above, it should already be covered, provided your IR does the paperwork properly.

4. This is a valid point. However having blocked jugulars and or azygos corrected is something that can be done right now. If other things are found in the future, at least you have started to attack the problem.

The clinical trials are a tremendous step forward, but having the procedure done independently of them certainly makes sense to me.

I too am sad about the PPMS exclusion. Although I'd worry about anyone on steep PPMS descent being in a sham arm of a trial. I guess PPMSers are excluded because it takes longer to show effects? With RRMSers you can capture effects more quickly, because there are changes.

On the flip side, with PPMSers, you know what the expected course is, so if you can change that expected course, it would be powerful evidence. And immunomodulators have not been as much use in PPMSers, so it can be assumed that the immune side of the equation is not as much at work in PPMSers, and that there is a need to find what is causing the continuing decline if it is not the immune system.

I do not see the exclusion of PPMSers as a reason to think this is not a viable treatment for PPMSers.

I had the treament two and a halve months ago. I've got PPSM. It worked out very well for me!

So, from now on, nobody can say: it doesn't work for ppms, because it worked in at least one case (I know there are many more) !

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I'm ready, I'm ready !

I too have PPMS. Liberated Aug 2... didn't see anything the first couple of weeks...now I see that I have more energy (not sleeping afternoons), less cog fog (no more searching for words, can focus on more complicated tasks etc.) I hope for more, but if that's it, it has made a world of difference. If it abates in the future, I will be thrilled for the chance to have had this time. That's the way I look at it anyway

I really hope and pray it works for my other half-our life would be transformed if it did. To be able to go for a walk that lasts longer than 20 minutes and no limping involved...simple pleasures really.

I do feel a bit guilty when I bring up the subject of CCSVI with him because he is not as enthusiastic as me about the procedure. I also worry about the 3rd of people who seem to get worse-I think that is the statistic gained so far. I don't want him to get worse, I want him to get better!!

I just think its a risk worth taking, but its not my neck on the line..pun intended.

That is misinformation. The rule of thirds comes from Dr. Siskin: one third have 'wow' improvements, one third have mild improvements, one third have no change.