Tuesday, June 29, 2010

Julie’s Position on CCSVI Research

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UPDATE: It seems that just as I was publishing the blog below, this press release was also posted: Clinical Trial Testing New Multiple Sclerosis Treatment to Launch in Buffalo1. I am thrilled that this research is being undertaken. I am confident that if these preliminary trials go well that this will go far in allowing other researchers to convince their IRBs to allow similar research at their institutions (and result in additional funding from varied sources).
ORIGINAL POST: I guess that I didn't explain my position on research around chronic cerebrospinal venous insufficiency (CCSVI) well enough, as many people reading my blog on Research Directions Around CCSVI2 seemed to think that I am against treatment trials for CCSVI. It is only because I think clinical trials worthy of publication in peer-reviewed journals (which is necessary for acceptance by the vast majority of doctors) are so important, that I say that there are still many questions to be answered through research before such a trial CAN be undertaken.
Let me explain something - something real, that all of the yelling, screaming and name-calling cannot change, despite how angry, desperate or anxious any of us are. There is a process to conducting clinical trials, especially at major universities in the US. In order to get approval for conducting any trial that involves humans, there is a very, very stringent approval process that has to be passed. A committee called an institutional review board (IRB), also known as an ethical review committee, must approve any study that is to be undertaken at that institution (even studies that just involve asking people potentially sensitive questions about their health have to pass this process). It is the number one job of these committees to make sure that patients are not put at more risk than necessary at these institutions, not only for the sake of the patient, but also as a CYA for the institution itself (no small factor here).
As someone who has worked to get study protocols through this process as a researcher at a university (Johns Hopkins University, to be exact), I can tell you this - there is NO WAY that a treatment trial on CCSVI would make it through an IRB process at this time. No way. There are far too many questions to be answered about:
  • causality of the condition itself and correlation with MS,
  • diagnostic methods are far from perfect,
  • the intervention methods use equipment that is intended for use in arteries,
  • the data that would be collected needs to be agreed upon,
  • the right specialists (neurologists, radiologists, interventional radiologists, vascular surgeons) need to collaborate on the proposals (and convince their departments that this is worth pursuing).
That is not all - the list goes on of what would need to happen to get to "yes" on this one.
In order to move forward on this, there needs to be preliminary data that provides a solid foundation for these pioneer researchers to jump off of and use to convince universities and hospitals that this is a valid (and safe) direction to go. Believe me, an "I don't know" answer that doesn't directly relate to the hypothesis of a treatment trial (namely, something along the lines of "treating CCSVI - using the methods in this protocol - will result in clinical improvement of symptoms of multiple sclerosis3") will kill any trial before it gets off the ground. You can send links of remarkable before and after YouTube videos and links to forums outlining fabulous results, but that does not count as "data" to the people that have to sign off on these studies.
I have learned a couple things over the years about activism and getting results. If we want to move quickly on CCSVI treatment trials, we have to: 1) choose our targets (those people who can get us to the next step), 2) we have to have a very clear vision of what "success" is (I believe it is trials that give us results that are sound enough that the results are accepted by docs, and ideally, insurance companies), 3) we have to understand the steps of how we get to success.
In the meantime, if anyone wants to - and has the means to - get their CCSVI treated, by all means, do so. More power to you. I am very anxious to see this line of research pursued so that EVERYONE who could benefit from this surgery could have access to it - not just the lucky few who are persistent and wealthy enough to find a doc that will do it "off label" or overseas. Unfortunately, this process takes time and a whole bunch of steps that people with MS would like to see skipped.
Read more: Understanding MS Clinical Trials4
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Clinical Trial Testing New Multiple Sclerosis Treatment to Launch in Buffalo

Researchers at the University at Buffalo, led by the Department of Neurosurgery, will embark on a landmark prospective randomized double-blinded study to test the safety and efficacy of interventional endovascular therapy—dubbed “liberation treatment”—on MS symptoms and progression.

(Vocus/PRWEB ) June 28, 2010 -- Recently, chronic cerebrospinal venous insufficiency (CCSVI) has been strongly associated with multiple sclerosis (MS). In a series of original studies, Dr. Paolo Zamboni of the University of Ferrara, Italy demonstrated blockage of major venous outflow from the brain and spinal cord in patients with MS. Researchers from many institutions, including the University at Buffalo, have confirmed the association.

It is hypothesized that the narrowing in the large veins in the neck and chest might cause improper drainage of blood from the brain, resulting in eventual injury to brain tissue. It is thought that angioplasty—a treatment commonly used by cardiologists and other endovascular surgeons to treat atherosclerosis—may remedy the blockages. Dr. Zamboni has further conducted preliminary studies suggesting the efficacy of venous angioplasty (“liberation procedure”) in the amelioration of MS symptoms.

Now, researchers at the University of Buffalo will launch PREMiSe (Prospective Randomized Endovascular therapy in Multiple Sclerosis) to determine if endovascular intervention via balloon angioplasty to correct the blockages improves MS symptoms or progression. PREMiSe is believed to be the first IRB-approved prospective randomized double-blinded study of balloon angioplasty for MS being performed in a rigorous fashion in the US with significant safeguards in place to ensure careful determination of risks and benefits.

The study is being led by principal investigator Dr. Adnan Siddiqui along with co-principal investigators Dr. Elad Levy and Dr. L.N. Hopkins of the University at Buffalo Department of Neurosurgery. Additional independent researchers from University at Buffalo will participate in the evaluation and follow-up of study patients. An independent Data Safety Monitoring Board (DSMB) will ensure the safety and effectiveness of the study on an ongoing basis.

In the first phase of the study, ten MS patients from the United States and Canada exhibiting venous insufficiency will undergo minimally invasive venous angioplasties to determine if the procedure can be performed safely. The procedures, scheduled for June 29 and 30, 2010, will be performed by click here to read more

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Thursday, June 24, 2010

News Detail : National MS Society Reminder

Sign up for the live webcast, “What’s new in MS research and treatment”: June 30, 1:00 – 2:30 p.m. ET

On June 30, join Dr. Patricia O’Looney, Vice President of Biomedical Research at the National MS Society, as she moderates a panel of experts during a live webcast about “What’s new in MS research and treatment,” focusing on new leads in stopping, reversing and preventing multiple sclerosis.
Register: To register for the webcast,  Click here

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Why Certain Diseases Go Into Remission During Pregnancy

During pregnancy, many women experience remission of autoimmune diseases like multiple sclerosis and uveitis. Now, scientists have described a biological mechanism responsible for changes in the immune system that helps to explain the remission.

The expression of an enzyme known as...read here

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Wednesday, June 23, 2010

Water-lilyImage by tmblue via Flickr
Cross-sectional study assessing long-term safety of interferon-{beta}-1b for relapsing-remitting MS

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Progression types of Multiple sclerosisImage via Wikipedia
Study shows people with Multiple Sclerosis can exercise more with breaks
A study presented at a conference in San Antonio, Texas shows that people suffering from Multiple Sclerosis who take more rest breaks are able to exercise for...read more

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Tuesday, June 22, 2010

 YouTube - From service dog to SURFice dog - Inspirational video
This such an moving video...enjoy

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Preparation of amantadineImage via Wikipedia
MS Answers

Q :

I would be very interested to know of any serious long term side effects of drugs that help with fatigue such as Amantadine, Modafinil and Ritalin.
Read More

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MS Society of Canada - News in Research
Fatigue is a common, but still one of the least understood symptoms in multiple sclerosis (MS). Authors aimed to investigate whether fatigue was associated with demographic-, clinical-, health-related quality of life (HRQoL)- and physical performance variables, and whether change in

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Friday, June 18, 2010

Map of CanadaImage via Wikipedia
Image by Kieran 2009 via Flickr

Work elsewhere hasn't entirely supported his findings. So it's not clear if MS causes blocked veins, if blocked veins cause MS, or if the two are entirely unrelated.
But that hasn't stopped Canadian MS patients from travelling to clinics in Europe and paying for the procedure.
The MS Society of Canada wants...read more

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News Detail : National MS Society
A collection of pivotal MS papers – featuring guidelines on stem cell transplantation research, pediatric MS, and other topics – is now online in a “Web Focus” feature from Nature Publishing Group, a publisher of high impact scientific and medical information. The National MS Society and its drug development subsidiary Fast Forward sponsored this collection to...read more

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News Detail : National MS Society

News Detail : National MS Society
Jun 10, 2010

Sign up for the live webcast, “What’s new in MS research and treatment”: June 30, 1:00 – 2:30 p.m. ET

On June 30, join Dr. Patricia O’Looney, Vice President of Biomedical Research at the National MS Society, as she moderates a panel of experts during a live webcast about “What’s new in MS research and treatment,” focusing on new leads in stopping, reversing and preventing multiple sclerosis
read more

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Featured Masters Questions and Answers
June 2010
Please visit our archived questions and answers from previous Masters of MS by clicking here.
Robert Zivadinov, MD, PhD
Director, Buffalo Neuroimaging Analysis Center (BNAC)
Associate Professor of Neurology With Tenure
University of Buffalo, The State University of New York

What is the current status of chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis?
Right now, procedures to evaluate and treat CCSVI are still in the early research stages. It is important to emphasize that only through carefully controlled research can we truly understand the effect of venous insufficiency in people with MS and how treatments related to the condition might benefit these patients.
In a small pilot study we conducted jointly with Dr. Paolo Zamboni’s group in Italy, 16 MS patients with severe documented CCSVI were given intravascular treatment with percutaneous transluminal angioplasty (PTA) either immediately or following a 6-month delay. The one-year findings of that study will be presented at the 2010 ECTRIMS meeting in Sweden in October. In this trial, the primary outcomes were change in volume of lesions on MRI and number of MS relapses.
Our group in Buffalo is undertaking a larger placebo-controlled trial (PTA versus a “fake” treatment) in 30 RRMS patients. This study will compare many of the standard outcomes in MS but will also include important quality of life measures such as pain, fatigue, and mobility. This study will soon begin enrolling patients at the University of Buffalo.
Suggested reading:
Zamboni P, Galeotti R, Weinstock-Guttman B, et al. Endovascular treatment for chronic cerebrospinal venous insufficiency in multiple sclerosis: a longitudinal, magnetic resonance imaging, blinded pilot study. J Vasc Surg. 2010;51:794 (abstract).
How is CCSVI related to the pathogenesis of MS, based on what is known right now?
The basic theory behind CCSVI is that blood is not properly draining from the brain and spinal cord. CCSVI can include several different types of venous anomalies, including constrictions external to the vein and intraluminal anomalies. The internal jugular and azygous veins are among those involved.
Vascular abnormalities in patients with MS are not a new concept—they were first identified in the 1800s and have been described since the 1930s. Nor are venous insufficiencies specific to MS. Our studies have found CCSVI in about 25% of normal individuals and about 40% of those with neurologic diseases. It could be that an abnormality of the blood vessels triggers an immune response leading to the inflammation and myelin degradation seen in MS, possibly related to deposits of iron in the brain.
My view at this point is that CCSVI is associated with MS; however it is yet to be determined whether CCSVI is among the risk factors that, along with others, increase a person’s susceptibility to developing this disease. The fact that CCSVI prevalence is about 38% in patients with a first clinical attack of MS and almost 90% in those with secondary progressive MS and a disease history of 20 years suggests to me that venous insufficiency has a high likelihood of affecting people with MS over time.
Suggested reading:
Zamboni P, Galeotti R, Menegatti E, et al. Chronic cerebrospinal venous insufficiency in patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2009;80:392-399.
University at Buffalo, The State University of New York. First blinded study of venous insufficiency prevalence in MS shows promising results. Press release, Feb 10, 2010.

  Should people with MS seek diagnosis and/or treatment for this condition?
In my opinion, there is currently no role for “open-label” treatment outside of well-designed research studies. Any vascular procedure carries a certain degree of risk, including risk of morbidity and mortality. Vascular surgical risks may be compounded if a patient travels long distances to undergo a procedure and returns via air travel without adequate recovery time, on anticoagulant therapies, etc.
Clearly, more research is needed to determine the best methods for treating CCSVI in patients who are diagnosed with this condition. A study in California was halted because of deaths in patients whose jugular veins were opened with stents, which are designed for arteries rather than veins. We don’t know at this time whether some form of stenting may be an approach to treatment. At this time we are not recommending stenting.
Research is also needed to determine the best approach to diagnosis and what groups of patients might be screened. Doppler ultrasound is an excellent noninvasive diagnostic method and may be useful for screening purposes, but this must be done by experts with appropriate training in identifying venous anomalies. Selective venography is the gold standard for CCSVI diagnosis but is currently not appropriate for screening purposes because of the invasive aspects, costs, and risks associated with this procedure.
Suggested reading:
Zamboni P, Menegatti E, Galeotti R, et al. The value of cerebral Doppler venous haemodynamics in the assessment of multiple sclerosis. J Neurol Sci. 2009;282:21-27.

 What should neurologists tell their patients about CCSVI?
Research to determine how to diagnose CCSVI, how and whether it should be treated, and whether the treatment benefits patients with MS is just getting under way. So the only thing neurologists can do is either wait and see, or send the patients to one of the few centers where studies are being conducted.
I predict the debate about the role of CCSVI in MS may get even hotter as more centers attempt to do Doppler exams on patients without the proper training, thus obtaining negative findings.
On the other hand, we have to understand that people with MS have a right to information and an urgent need for answers to these questions. It was only a few years ago that many people doubted the benefit of stem cell treatments in MS, yet now this is emerging as a feasible option. So we can’t shoot down revolutionary types of treatments that may offer hope for patients. We need to listen to our patients, understand that our existing treatments do not completely manage the daily burden of MS, and keep an open mind to any new approaches that might help these patients. Before any new treatment can be recommended, it must first be examined in rigorous research studies.

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Thursday, June 17, 2010

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Wednesday, June 16, 2010

FDA Advisory Committee Unanimously Recommends Approval of Novartis Investigational Treatment FTY720 to Treat Relapsing Remitting MS
EAST HANOVER, N.J., June 10 /PRNewswire/ -- Today, an advisory committee of the US Food and Drug Administration (FDA) recommended approval of FTY720 (fingolimod) for the treatment of patients with relapsing multiple sclerosis, the most common form of the disease. The FDA has the option of seeking the advice of one of its advisory committees as it reviews and decides whether to approve a new treatment. The committee voted unanimously that FTY720 demonstrated substantial efficacy in treating relapsing remitting MS and that safety of the proposed 0.5 mg dose justified approval
click here to read more

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Age-standardised disability-adjusted life year...Image via Wikipedia
A simple blood test that can predict multiple sclerosis up to nine years before symptoms appear is being developed by scientists.
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Intrathecal methotrexate treatment may help stabilize progressive MS
Submitted by hollie on Tue, 2010-06-15 12:54. Research

Although clinical research in MS seems to be at an all-time high level of activity, this activity remains heavily concentrated on relapsing-remitting MS as opposed to progressive forms of MS. This is understandable -- relapses can be reduced by manipulating cells circulating in the immune system, and there are many ideas for ways to manipulate these cells. However, the need for therapies is much more urgent for people with progressive MS.

Recognizing this need, a team of researchers at the Multiple Sclerosis Research Center of New York recently conducted a treatment study involving methotrexate administered intrathecally (in the spine). Methotrexate is one of many cancer-fighting agents that have been investigated in MS because of their effect on immune cells. Usually it is taken orally, but an intrathecal version is available to treat leukemia in cerebrospinal fluid. Injecting methotrexate intrathecally gets it past the blood-brain barrier and closer to the scene of disease activity.

In this study, 87 subjects with secondary progressive MS and 34 with primary progressive MS received up to 8 treatments given every 8 to 11 weeks. Each subject was evaluated a year after their last treatment using the EDSS scale. The SPMS group had a lower average EDSS score at the end of the study compared with their starting score, with 89% of the subjects either improving or staying the same. In addition, 82% of the PPMS subjects had no significant progression. Importantly, no serious side effects were observed.

There are several drugs in the MS pipeline that are thought to have neuroprotective effects and thus may improve the health of people with progressive MS. While we wait for those drugs to be brought to market, perhaps intrathecal methotrexate should be studied more extensively since it's available now and has the potential to help people with progressive MS.

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Friday, June 11, 2010

B.C. team to test theory of vein efficiency in MS patients, and how to detect it
B.C. doctors will be part of a $2.4-million, two-year research study to look at whether a controversial treatment for multiple sclerosis is legitimate.

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Multiple Sclerosis Society of Canada - National News Releases
Toronto, Ontario - June 11, 2010 - Over $2.4 million has been committed by the Multiple Sclerosis Society of Canada and the National MS Society (USA) to support seven new research projects focusing on chronic cerebrospinal venous insufficiency (CCSVI) and its relationship to MS.

read more

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N.S. MS patient feels renewed after 'liberation'
"I was no longer walking with two canes because of my balance. My balance had almost immediately improved as well. Once I got out of bed I shed a cane immediately. I was walking with one cane.
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It's starting! - 
CCSVI Scanning and Treatment about to start in UK

CCSVI Dopplar Scanner

We are pleased to announce that we have now taken delivery of our Premium Echo Doppler Scanner System. This scanner has been specially designed by Professor Zamboni and his team for the diagnosis of CCSVI. We are also proud to be the first clinic selected in the UK to have this equipment and we have been told that currently no other establishment in the UK and Ireland is using this sophisticated equipment.

Professor Zamboni devised five specific protocols for the detection of CCSVI and this equipment is programmed with the algorithms created to aid the analysis of these five protocols. These special measurements available with this equipment have recognised the needs of this type of scanning - and the fact that existing scanners may struggle without the specific measurements required.

More Good News!
We can also announce that within the next seven days we will be offering appointments for Doppler Scanning & Doctors Consultation to a large section of our waiting list. These will be available during September and October. We are also in advanced discussions with other leading Doctors, at prestigious medical facilities, to replicate the treatment protocols and standards that we are establishing in Scotland. This will enable us to have an increased capacity and reduce our waiting lists even sooner. More information will be given as soon as we have it available.

If you are not already on our waiting list, we strongly recommend that you reserve your place now. Click here for more information.

Testing and Procedures

If we find patients are demonstrating that some stenosis is present, our Doctors will discuss this with you and possibly recommend transfer to one of our Partner clinics; where a CT Venogram will take place to find the precise location of any narrowing, for intervention if necessary.
As part of the on-going research, patients will also be invited to have an MRI Brain scan (at no extra charge). This will then be repeated in six months when patients return for their follow-up Doppler Scan.

Details have also been finalised with our Partner clinic in Scotland for the CT Venogram, MRI Brain scan and Venoplasty procedure. Starting in August we aim to have the whole procedure from initial Doppler Scan completed within 3-5 working days. For those with appointments before August; the timescale might be slightly longer as we begin to fit all the procedures together.

Transport & Accommodation
We have been in discussion with a company who is interested in providing a bespoke transport service for our CCSVI patients, to and from hotels and clinics; in most cases for less than the cost of regular taxis. We expect this will be very popular, especially as they will have specially adapted vehicles to ensure that those with mobility difficulties are catered for.
For those people requiring information on accommodation in the area, we will have details on a number of hotels that we have used in the past. However we do strongly recommend that you search around on the internet as some excellent offers can be found with a bit of research.
More information on the transport facility and accommodation will be available on our website, as soon as we have it, with links through to them for booking. Please make all your arrangements direct with the companies concerned.

CCSVI Conference
CCSVI is one of the most talked about topics in medicine at the moment with twelve articles published in medical journals in April alone.
We have started preparations for a CCSVI conference at Glasgow in November 2010. This will bring together all the leading people in the world of CCSVI. It is vital to be involved in an international collaboration to collect similar data to strengthen the case for CCSVI. We are already working with these leaders to put this in place.

Please note: we are unable to take orders/payment for the waiting list or Treatment Packages over the phone.

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FDA panel votes to recommend approval for Gilenia


The Peripheral and Central Nervous System Drugs Advisory Committee, appointed by the FDA to conduct an expert review of Novartis' new oral MS drug Gilenia (aka fingolimod or FTY720), met today and voted to recommend approval for this therapy. The panel discussed the side effects that have been observed in clinical studies (such as cardiac problems, an eye disorder called macular edema, and impaired lung function), but ultimately decided that the benefits of Gilenia outweigh these risks. The panel did recommend that a lower dosage of the drug be evaluated -- but agreed that this additional study could take place after approval of the current proposed dose (0.5 mg). The committee also voted in favor of making Gilenia available as a first-line treatment rather than only as a back-up if other treatments don't work.
The FDA is expected to decide whether to approve Gilenia in September. It usually follows the advice of its advisory committees, although it's not required to. Assuming Gilenia is approved, it will most likely be prescribed in conjunction with a safety monitoring plan to identify any possible new issues with the drug.
All of the background materials that the committee considered for today's meeting can be downloaded openly from the FDA website. These include information submitted by Novartis and reports prepared by FDA's scientific and medical experts. If you're considering trying Gilenia if and when it becomes available, you may want to read through this information, especially if you are concerned about particular side effects.

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Simple Eye Test Measures Damage from Multiple Sclerosis

A quick, painless eye measurement shows promise as a way to diagnose multiple sclerosis in its very early stages, and to track the effectiveness of treatments, researchers from UT Southwestern Medical Center have found in a multicenter study.
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Tuesday, June 8, 2010

We mustn't rush into a new MS treatment -- but we mustn't waste time, either

We mustn't rush into a new MS treatment -- but we mustn't waste time, either

The tension is mounting between research, medicine and patient communities whose lives are affected by multiple sclerosis (MS).
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Sunday, June 6, 2010

U3-X Personal Mobility Prototype

Honda rethinks the concept of personal mobility
 Honda — March 29, 2010 — With U3-X Honda rethinks the concept of personal mobility, providing the rider with freedom of movement in any direction forward, backward, sideways and diagonally by simply leaning slightly in the desired direction. The lightweight and compact one-wheeled device also features a foldable seat and retractable footrests. A lithium-ion battery pack provides power for up to one-hour of use and can be recharged by plugging in to a conventional household or office 120-volt power outlet.
Weighing roughly 22 pounds, U3-X uses an advanced Honda proprietary balance-control system which derives from its research into human walking dynamics for the development of the ASIMO bi-pedal humanoid robot. To realize full freedom of movement in all directions, the U3-X also employs the worlds first omni-directional driving wheel system (Honda Omni Traction Drive System) which utilizes a series of concentrically mounted wheels a larger, forward and backward moving inner wheel and a series of smaller sideways moving outer wheels. Diagonal motion is achieved when both forward and sideways moving wheels operate in tandem.
In addition, the compact size and one-wheel-drive design of U3-X was intended to provide user-friendly and pedestrian-friendly operation with low-mounted foot pedals that make it easy for the rider to reach the ground, and a seat height that places the rider at approximately the same eye-level as other people.

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