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It has always seemed to me that inadequate drainage of my brain was worth fixing, whether or not it cured my MS. May helped things I was suffering that have always been blamed on MS but could as easily be blamed on inadequate vascularization.

If we focus on improving circulation, we can get a good end-point for a short study and justify treatment without having to prove good results vis-a-vis MS.

Here are some easy examples...pre and post blood transit time. pre and post vein appearance on venograms; pre and post oxygen availability to the brain tissue; pre and post presence of metabolic waste products. etc.

With MS and espedcially progressive MS (near and dear to my heart) we will need a huge trial over a very long period of time to prove, scientifically, that there is a result. (That is why the pharmas always use RRMS, the relapses give them something concrete to count so they can get a significant difference over non-treatment in a reasonable time. Nothing wrong with that, just doesn't seem to correlate with progression).

You are so right and where/how do we start. There has been a lot of vocalization in my area about the vascular issue away from the link to MS. All the decision makers want to make this about MS and haven't even thought about the basic health issue of bad circulation. Except to say that venous drainage from your brain isn't an issue and we would all have bulging eyes and be unconscious.

I think many have tried to focus on circulation in an attempt to get insurance to cover treatment. I was treated in August and had so-so results and also had the pleasure of paying cash for the treatment. I've been wanting to get retreated and trying to get the funds together but now my legs are swelling---I think I have a shot at getting this time around covered--and maybe even getting the previous attempt reimbursed.

If the insurance would recognize that impaired venous drainage ought to be fixed regardless of the persons other maladies, it would be so simple. In the broad scope, this really isn't an expensive procedure---at least not compared to other things that are covered.

Just treating venous issues in everyone would uncover previously undiagnosed problems. I believe Barb Farrell was also treated for May Thurner which ought to have been treated despite her having ms---but no one looked.

Dr. Dake's study is focusing on the endpoint of if CCSVI venoplasty improves flow.

I am predicting that it does.

Cece wrote:Dr. Dake's study is focusing on the endpoint of if CCSVI venoplasty improves flow.

I am predicting that it does.

Cece, do you have a link to Dr. Dake's protocol? Of course, Ins. co.s can still say that ewe need to prove that improved flow is beneficial somehow. That is not as obvious to insurance co.s as it is to the rest of us.

fogdweller wrote:It has always seemed to me that inadequate drainage of my brain was worth fixing, whether or not it cured my MS. May helped things I was suffering that have always been blamed on MS but could as easily be blamed on inadequate vascularization.

If we focus on improving circulation, we can get a good end-point for a short study and justify treatment without having to prove good results vis-a-vis MS.

Here are some easy examples...pre and post blood transit time. pre and post vein appearance on venograms; pre and post oxygen availability to the brain tissue; pre and post presence of metabolic waste products. etc.

With MS and espedcially progressive MS (near and dear to my heart) we will need a huge trial over a very long period of time to prove, scientifically, that there is a result. (That is why the pharmas always use RRMS, the relapses give them something concrete to count so they can get a significant difference over non-treatment in a reasonable time. Nothing wrong with that, just doesn't seem to correlate with progression).

From the moment Zamboni theorized in public that stenoses causes MS, the two were inexorably linked. How much simpler things would be if Zamboni had just said he found a circulation disorder that mimics the symptoms of MS.

It is a good idea, fogdweller, but I am afraid that ship has already sailed.

I totally agree with the fact that we should concentrate on the circulation issue... but would it be enough? For example some people have Raynaud's syndrom, they have bad blood flow to the extremities, but that doesn't cause their extremities to have iron deposits right?
Also Ranaud tend to burn itself out so if it is from some sort of infection, it gets better over time... However with MS, the blood flow issues seem to be an effect more than a cause... I mean it may be a cause for iron deposits on the brain but that same cause is probably an effect to something else happening in the body and that is why people restenose... I am quite sure that people who have Prkinson or Alzheimer must have the stenosis too, at least in their azygos... It's certainely not congenital but I've always wondered if it was not some kind of protective reaction of the brain against some inflammation coming from the gut... it would be an attempt to protect brain tissues but at the same time causes its slow death...
SO yes, focus on blood flow issues but damn it, we have to find the cause of the stenosis....

fogdweller, the information on Dake's study was in some articles at the time of the ISET conference (mid January). I haven't got the protocols, alas.

codedweller wrote:From the moment Zamboni theorized in public that stenoses causes MS, the two were inexorably linked. How much simpler things would be if Zamboni had just said he found a circulation disorder that mimics the symptoms of MS.

It is a good idea, fogdweller, but I am afraid that ship has already sailed.

I agree and I've thought of that very thing. I love Zamboni for having the courage to press forward with this whole idea of CCSVI and I believe he will win a Nobel Prize someday for it. But when he put it out there linked to MS, like you put it, that ship has sailed.

I've even wondered how Dr. Zamboni ever thought about it possibly being a vein problem given the fact that the methodology to test for it using doplar ultrasound is so specific.

WeWillBeatMS

codefellow wrote:From the moment Zamboni theorized in public that stenoses causes MS, the two were inexorably linked. How much simpler things would be if Zamboni had just said he found a circulation disorder that mimics the symptoms of MS.

It is a good idea, fogdweller, but I am afraid that ship has already sailed.

Actually, I was addressing a very specific problem. I should have been clearer. Trying to craft a clinical study to scientifically prove the effectiveness of angioplasty for the treatment of CCSVI is the problem I was addressing. Devising clinical studies for MS are notoriously difficult. The disease is highly variable (different in each patient) and the rate of progression or even the rate of relapses is highly variable. Progression is even more difficult to study since there is no good, objective charachteristic we can measure. (That is why pharma always studies RRMS; they can count relapses. Progression is more difficult to measure and requires huge studies over a long time period to reach statistical significance. Just too expensive.)

A clinical study must prove that the treatment is "safe" and statistically "effective" vs. the untreated group (or placebo group if you have a placebo controlled study.) "Safe" is a piece of cake. PTA (Percutaneous Transluminal Angioplasty) is very safe. The issue is "effective". If we define the endpoint as improved circulation, or improved vascular architecture (good looking veins) or improved blood transit times in the brain, it may be achievable with a reasonable number of patients and reasonably quickly, and with pretty good objectivity. That is what I am proposing.

The issue, of course, is that we have to begin with the premise that improved circulation, e.g. blood brain transit time is meaninfull and beneficial. Seems obvious to me, but the FDA and the Insurance Co.s may argue that there is no proven reason to seek to achieve that end point.

I totally disagree with Fogdweller:
"Idea ... lets ignore MS and focus on circulation".

To take this approach you have to:
- Ignore the available evidence on MS
- Ignore Prof Zamboni's statement that MS is multifactorial
- Agree with MS experts/most neuros/naysyers who say CCSVI liberationists are misguided and must be discounted.

Advocating for the treatment of CCSVI syndrome is difficult enough using science. Please try to resist non science ................

MarkW

MarkW wrote:I totally disagree with Fogdweller:
"Idea ... lets ignore MS and focus on circulation".

To take this approach you have to:
- Ignore the available evidence on MS
- Ignore Prof Zamboni's statement that MS is multifactorial
- Agree with MS experts/most neuros/naysyers who say CCSVI liberationists are misguided and must be discounted.

Advocating for the treatment of CCSVI syndrome is difficult enough using science. Please try to resist non science ................

MarkW

I am not making the suggestion that we ignore the MS connection in the big picture. Just that we try to find an acceptable justification to perform the PTA to treat CCSVI. To do so we will need to complete scientifically acceptable studies for the scientific community and for the Insurance Co.s and for the FDA. (In the U.S. If I recall you are in England, so no insurance co.s and no FDA). That will take 7-12 years if we are trying to show that we are impacting MS. We can do it in 2-3 if we are trying to show that we improve brain circulation. Then the flood gates will open for treatment of CCSVI for whatever benefit, and we can do the MS studies at our leisure since everyone can get treatment.

To take this approach you have to:
- Ignore the available evidence on MS

Yes. Compartmentalize, assuming that, as most neuros/naysyers would like you to believe, CCSVI is not something which is reflected in any current evidence on MS, but is actually a normal variant of vein anatomy which can be expected in most people regardless of whether or not they have 'MS'.

- Ignore Prof Zamboni's statement that MS is multifactorial

That is irrelevant to this argument. One can treat veins as veins, whether 'MS' is caused by germs, or the boogey-man.

- Agree with MS experts/most neuros/naysyers who say CCSVI liberationists are misguided and must be discounted.

Not a bit of it. Argue strenouously that it is a legitimate treatment for a legitimate health problem, more demonstrably affecting human pathology than say for instance CFS.

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I am not making the suggestion that we ignore the MS connection in the big picture. Just that we try to find an acceptable justification to perform the PTA to treat CCSVI. To do so we will need to complete scientifically acceptable studies for the scientific community and for the Insurance Co.s and for the FDA. (In the U.S. If I recall you are in England, so no insurance co.s and no FDA). That will take 7-12 years if we are trying to show that we are impacting MS. We can do it in 2-3 if we are trying to show that we improve brain circulation. Then the flood gates will open for treatment of CCSVI for whatever benefit, and we can do the MS studies at our leisure since everyone can get treatment.

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This is true. Forget 'MS'. What did it ever do for you? We need to accumulate a set of strictly measurable symptoms, preferably measurable without human intervention, as in measuring heart rate or BP. These must be demonstrable as being directly treated by CCSVI intervention. How real are the hand and foot temperature effects? Seems to me these can be very accurately measured using standardized equipment. There is a standardized cognitive test which has been demonstrated to be affected by arterial blood pressure in monkeys. This test could be administered immediately before and after angioplasty. It affects executive function. Like the PASAT, which might be usable to quantify brain fogginess, it would be very difficult to confound.

What other symptoms are most commonly affected by the angioplasty? Dizziness? Slurred speech? They have to be measureable!!

Walking speed and others are the ones that will stretch it out to five years. Shorter term fixes will give us shorter term goals to reach.

1eye wrote:

Walking speed and others are the ones that will stretch it out to five years. Shorter term fixes will give us shorter term goals to reach.

Exactly my point! One "end point" could be sustained flow in the jugulars. Period. Or maybew better would be blood transit time through the brain. This is easily measurable, and it would be hard to argue that something that results in a statistical improvement in blood transit time is not justifiable treatment. Other measurements could be levels of oxygen in blood after it is leaving the brain, i.e. in the various veinous locations. Also levels of various metablolic waste products. I have not researched these but I am sure they are easily measurable. You are not going to have placebo increase in blood mean transit time through the brain. It would be pretty objective as long as the technicians doing the measuring are blinded, a pretty easy task.

A clinical trial of that nature could be conducted cheaply and very fast, say less than a year, and with a resonable number of trial subjects, so we could have an answer very soon. Getting an answer on clinical progression of MS with and without angioplasty would take decades and huge number of trial subjects, so if we are going to wait for that, it won't do me any good. I am aready almost 60.

All we have to do is convince the FDA that increased blood transit time is beneficial. Or decreased metablolic wast accumulation. Or whatever physiological measure we decide to use.

My goal here is to come up with some study than can be done cheaply and fast that will justify PTA for CCSVI. Studying its effecto on MS will surely be important, MarkW, I do not dispute that. However this is a way to make PTA available without waiting to prove that it is a treatment for MS. We can and will continue to study that. In fact it will probably be faster if PTA is paid for and readily available (and proven to be at least of some benefit.)

increased blood transit time is beneficial I know you meant decreased. With science, does it matter if your audience is the FDA or a peer-reviewed journal? Dr. Freedman complains that procedures do not require clinical trials, but I hope he never needs a new one, or ends up like Dr. House, in his bathtub, operating on himself... Anyway perhaps such a study should be addressed to those expected to make changes because of it: insurance companies and legislators. Perhaps it could be spelled out to them the kind of changes the study is designed to allow.