This Is MS Multiple Sclerosis Community: Knowledge & Support

About six months ago I put you in contact with an Australian IR you previously knew or know of. He also applied for approval for a study here in Aus (and was rejected). Last time I saw him he explained the design of the study, and it sounded pretty interesting. Maybe you could email him again for clearer details.
The basics (from memory) were:
1. About 200 Patients (all MS)
2. Split into two groups (ie A & B each consisting of 100)
3. All patients would receive a venography, under a combination of 2 anaesthesia's. I don't remember the names of them, but one caused the patient to loose all track of time (so they had no idea how long they were in the operating theatre) and the second caused them to forget what happened during the procedure, with neither actually causing the patient to black-out, so they remained responsive to the person performing the procedure (ie hold your breath etc etc)
4. Half the patients would also receive treatment on this "first" venography, but no-one would be told if they did or didn't.
5. The raters were blinded to which patients were treated, and the dr's performing the venographies were to be kept away from the patient groups and raters.
6. Two months later, ALL patients would again undergo the venography, with the second group (not treated the first time) receiving treatment this second time. The patients that were treated in the first pass would be checked and treated for any restenosis.

The thing that sounded good regarding this study, was at worst, you would be treated in 2 months.

The dr's performing the venography / treatments are kept separate to the rest of the studies participants (ie patient, raters etc etc) so it attempts to approach the double blind criteria. They also had sneaky plans to push the placebo effect, but that would be hard to explain, clearly, not that the above does it all justice. I guess I simply liked the fact that worst case you would be treated in 2 months.

They also had plans to expect a % of people they didn't find CCSVI in, and the 200 (I think) number was based on achieving a certain confidence interval, assuming they didn't underestimate the number of people not found to have CCSVI.

ok dr s. I know you are not hot to trot for stents but are the problems with them occluding caused by cell proliferation. Seems like ms folk have sticky veins(or sticky blood ) besides malformed veins. My humble opion a large dose of NAC (n-acetyl cysteine) taking continuously forever. this has been found to reduce excess cell proliferation even in cancer studies. It also is antiinflamatory and of course increases glutthione production. Hey my angioplasty from you didn't last to long I deffinately feel worse. But I also deffinately got intial improvements. So I will try again . Maybe larger ballons and web removal will be the trick. I stillthink dakes stent patiients have the highest incidents of long term improvements.But I understand your fear or worse damage. I think if you really keep an exact running chart of complaints of restenosis you are going to hear pains in neck , feeling of lack of oxygen, tiredness, cognitive fuzziness, and of course increased disability. don't ignore the aches in necks or on forehead where the veins are.these are signs. B

It could also good for people to take before a CT scan to help protect against potential negative effects caused by the contrast dye.. here is an article about it.

Thinking over what jak7ham9 said, one thing that stands out for me is that Dr. Dake was able to do a two-month check-up, at which many or most patients received an additional venoplasty or stent. His results may speak to the value of follow-up care, not the use of stents.

Jak7ham9, wishing the best for you.

A quick question: why not to wear a neck brace (cervical collar?) in order to avoid the neck movements that could disturb the healing/incorporation of stent to the vein?

however jumping to a randomized trial is premature. It is like .... Randomized trials come after safety has been determined, after best practices have been determined and only then.

But we want to be treated now, and the ethics comities are blocking our treatment (such as yourself) until efficacy of treatment is proved. Damned if you do, and we are damned if you dont.

it is virtually impossible to prevent motion of the neck, even in a rigid collar.

Today, i reviewed a stent placed in the upper neck. The stent has clearly been damaged by compression against the transverse process of the second cervical vertebra

Other things are also compressed by the stenting process. Did I mention stretch or compression of the accessory nerve, also known as the 11th cranial nerve. It lies very close to the jugular vein in the upper neck and compression of this nerve leads to shoulder weakness, sometimes lasting a very long time.

Cece wrote:
Thinking over what jak7ham9 said, one thing that stands out for me is that Dr. Dake was able to do a two-month check-up, at which many or most patients received an additional venoplasty or stent. His results may speak to the value of follow-up care, not the use of stents.

Jak7ham9, wishing the best for you.


I can only speculate on any of these results. We have to wait for outcome results in publications.

I wish everyone had a follow up care plan. It is not a one shot deal at this point for most. Our results unfortunately will not be in medical publications because they were not in trial form. (I think )

Certain types of xray dyes have virtually eliminated this risk in most patients.

my biggest concern about stents is that when they fail, there is not much that can be done for them. When angioplasty fails, it can be repeated.
...

Recurrent symptoms really bothers me. The ideal strategies for effective angioplasty probably has not been fully worked out. Might several dilatations over a few months improve the remodeling of the abnormal collagen in the areas of obstruction?

I realize we have a long way to go before the standard is set for treating CCSVI. The various methods seem to be multiplying. As for the accessory nerve damage, it is very real. The upside is it does repair itself. Those of us who had this problem saw the problem resolve within 4-5 months. I did wear a soft cervical collar soon after treatment and I can't say if it helped my stents to integrate properly, but my results were good. The collar helped the headaches I was having which were brought on by aggrivating the nerve. My stents are very high, so not everyone with stents will have this problem.



I think Dake's follow up plan has been very beneficial. In addition, he is always available via email for any questions or concerns. He responds within minutes in most cases. I have been in constant contact with him over the past year. We also send progress emails to him. I am most excited to see the comparison in MRI from my treatment to now. The baseline was charted for us, so we will be able to measure the progress or regression.
I wish everyone had a follow up care plan. It is not a one shot deal at this point for most. Our results unfortunately will not be in medical publications because they were not in trial form. (I think )