In January of 2015, I began the process to participate in a Clinical Trial for a controversial procedure for those with Multiple Sclerosis called CCSVI.  What the heck is that you say?  Forgive me, but I have to get technical for a minute if I am to explain it to you.  CCSVI stands for Chronic cerebrospinal venous insufficiency which is a term coined by Dr. Paolo Zamboni of the University of Ferrara in Italy. CCSVI describes a theory in which the veins in the head and neck are narrowed or blocked, and therefore unable to efficiently remove blood from the central nervous system.  More specifically, the pressure caused by the build-up of blood in turn causes reflux of blood back into the central nervous system through new blood vessels which develop when the others are not working properly. Dr. Zamboni suggested that because these compensatory blood vessels don’t have the same structural integrity as larger veins, they tend to leak blood into the surrounding tissue, depositing iron in the central nervous system and thereby triggering an immune response associated with Multiple Sclerosis.  Phew, did you get all that or have I lost you?

I first heard about this theory at least 6 years ago and at that time, it made perfect sense to me.  I was hopeful that this would be my ticket back to being normal again.  Back to being the girl who could go for hikes, the girl who could play softball or teach a fitness class.  Back to being the girl who could work 10 hours a day, 6-7 days a week, back to being the girl who could do 10 things at once and keep track of hundreds of programs and instructors and room bookings, etc.  I had high hopes, this was the cure I had been waiting for!  Just before I went on Long Term Disability, I heard about this Clinical Trial so I contacted the teaching hospital and set my sights on being included in the study.

There was a lot of criteria to meet before being included in this $5.4 million study and I won’t tell you all the boring details but it took some time before I was set to start.  Some of the criteria included:

• You had to have Multiple Sclerosis (MS), go figure
• You needed to have at least 2 years of regular follow ups with an MS specialist with records available to review
• You needed to have at least 50% stenosis on catheter venography if either internal jugular vein and / or azygos vein (I was told I had one that was 72% stenosis (narrowed), one was 54%) so I was in! Yay for me!
• You had to not be pregnant!!! Woot Woot! Thank goodness, that’s all I’m going to say about that
• You had to have had stable use of medications (those used for spasticity, depression, neuropathic pain, fatigue etc.) for 3+ months – how about 15 years? I think that makes me qualify.

I was told that the group of neurologists, vascular radiologists, MRI specialists, cardiologists and ethicists, nurses and researchers will conduct a safety and efficacy study on the new treatment for CCSVI that involves balloon dilation (venoplasty) of the blocked veins.  In regular folk language, those who met the criteria of showing narrowed veins (CCSVI) on the screening ultrasound and venography would be “randomly” assigned to receive either the sham or venoplasty at the baseline (the beginning of the study which acts as the starting point for gathering information moving forward).  After the first year, participants would cross over to the other intervention so all patients were to receive the venoplasty at some point during the study which was the main selling point for me. I had considered doing this procedure in Mexico or Scotland whichever I could get into first. Both countries had waiting lists of 4-5 years and would cost a minimum of $ 30,000. The goals of the this trial were to determine the safety and efficacy of treating CCSVI as an MS strategy. It was also to focus on the impact on quality of life and routinely used clinical and MRI outcomes. There ended up being 104 people who met the criteria in this study, which was conducted in Vancouver, Winnipeg, Montreal and Quebec City.  The study was “double-blinded”, meaning that neither the patients nor the physicians who evaluated them knew who was receiving the actual treatment or the sham procedure.

During this 2-year study, we needed to commit to blood tests (a lot of them), MRI’s (at least 4 over the 2-year period), Ultrasounds, ECG’s, Neurological, physical and nursing exams, patient reported scales (fatigue severity, pain and patient reported outcomes).  We also had to commit to 11 visits to the clinic / hospital in Vancouver (at my expense) and at least 4 phone interviews lasting 20-30 minutes each.  All of which, I was fully prepared to do, that’s how eager I was to participate. I would never have been able to participate had I been working though.  I just wouldn’t have had the energy, it was a big committment.  To get to Vancouver, I needed to drive for 45 minutes to catch a ferry which took 2 hours, then drive another hour to get to the hospital.  And, all appointments had to start at 8 am because they were an all-day party, which meant that I had to go over the day before as the ferries wouldn’t get me there in time for an 8 am start.  So, each trip was 2 days and approximately $400 when it was all said and done, that’s how committed I was to this trial.   This was voluntary participation and I could withdraw at any time with no penalties.  Don’t get me wrong, I am not complaining about this, I just want to show you how committed I was to the study.

I am saying nothing negative about the people working diligently for those of us with MS.  Staff at the hospital / clinic were knowledgeable, compassionate and thorough however I have a few things I want to get off my chest regarding the study itself. In October of 2013, the lead doctor in this study conducted another study to examine the association between MS and the narrowing of the veins which lead from the brain to the heart. This study looked at MS patients, non-MS siblings of people with MS, and non-MS volunteers and they found that there was no significant difference between rates of venous narrowing in people with MS, their unaffected siblings and unrelated people without MS.  If that is the case, why does the paperwork I was given when beginning this trial say that approximately 70% of MS patients have signs of narrowed (more than 50%) or blocked veins in the neck known as CCSVI?

Fast forward to March 8, 2017, when a media release came out saying the conclusions about the so-called “liberation therapy,” which many Canadians with MS have undergone since 2009, represent the most definitive debunking of the claim that patients could achieve dramatic improvements from a one-time medical procedure.  This information came out after I had officially been in the study for 19 months, not the entire two years, What the hell?  Oh yes…..and I received an email the evening before the “results” were released to the media (March 7) saying they were going to release results the next day.  I had to watch the news to find out what they had discovered.

Raegan,

We are all very grateful for your contribution that has led to a more complete understanding of CCSVI and its effect on multiple sclerosis. We are contacting you because we have recently analyzed the results up to the end of the first year for all participants.

The results of the study will be discussed at a major medical conference March 8th in Washington DC. A press release will go out to all major Canadian news networks. At this time we can only report the overall results and not your individual results.

The study enrolled 104 participants from across Canada. The key questions the study was designed to address were safety and improvement in patient reported outcomes such as fatigue, brain fog, pain, before the cross over at week 48.

The next step is getting this information published in a medical journal. That process can take several months because it is reviewed by experts who may ask for additional details. We will keep you informed of further major developments by mail or email whichever is your preference.

Once again, on behalf of the study team, thank you

Best regards,

Again, WTH?  I committed 2 years to this stinking study and they have the audacity to publish results early and come to a conclusion based on (in my opinion), incomplete data? How can it be complete data if the study was still in progress? How can they have definitive results when some people were only in their first year of the study since we all started at different times. Why didn’t they state that I had some benefits from this procedure and I would bet, some others did too.  I have yet to receive my personal results although we were told, At the end of the trial (after ALL participants have COMPLETED the two-year study visit) and the analysis of the study data has been completed), you will be informed about your venogram results and treatment assignment. The data analysis usually takes several months to complete.” It has now been 6 months and I haven’t received anything.

All of us were put under minor sedation, and we all had a catheter threaded through an incision in the groin to the area of vessel narrowing. For those receiving the actual treatment, the balloon was inflated once or twice; for those receiving the sham, the catheter simply remained in the narrowed area for the same amount of time, about one minute.  I can almost guarantee that I know when I had the actual “liberation technique” because even though I was “consciously sedated” during the procedure I had a very strange thing happen. During my first procedure, (which is the time that I believe I received the balloon angioplasty) there was a point that I could hear what sounded like a campfire crackling in my head.  I am ignorant when it comes to medical stuff, but I know my body well and I thought that it was blood flow starting to happen (as it should). Afterwards, my balance and energy level was noticeably better.  I could walk in the bush without holding on to my husband for support, something that I haven’t been able to do for at least 12 years. Unfortunately, this was short lived though. After about 2-3 months, my balance issues were back.  My un-medically, uneducated thoughts are that the veins re-narrow therefore restricting the flow of blood again.

I’m also annoyed that in the media release, it was stated that “Fortunately, there are a range of drug treatments for MS that have been proven, through rigorous studies, to be safe and effective at slowing the disease progression.”  I’m sorry, I don’t want to be on medications for the rest of my life, but I don’t want to continue to suffer from the debilitating symptoms and relapses that come along with the disease so what are my options?  I am so thankful for the guidance and wisdom of my own neurologist and I do believe my medications have slowed the progression of my MS, but my medications are expensive (close to $5,000 per month) which comes to a whopping $ 60,000 per year (thank god for mine and my husband’s medical coverage).  I wonder how much this procedure costs?  Even if it had to be done twice a year, it would maybe allow some of us to lead a much more active and healthy life drug free.  I feel that this study should have re-tested the veins and done another venoplasty to open the veins again using larger balloons or to see if they ever started to stay open longer and found that results were longer lasting as this was a relatively noninvasive procedure. But no, he told a local news station that “we didn’t see any sign of a clear improvement across measurements to justify going forward with a larger confirmatory study, it’s done”.  Those are pretty definitive words.  He does not believe that another penny or a minute of time should be spent to re-hash this study.  He believes the results of this trial will deliver the final death blow to so-called liberation therapy. I can’t help but feel that his mind was made up from his last study before this study even began. Again, I am not trying to criticize anybody doing this study, but I believe somewhere along the line, the integrity of it was somewhat compromised. At the very least, I feel that they should have permitted the study to run its course allowing all 104 people involved the opportunity to fulfill their commitment to help further the knowledge in the treatment of MS, and if it failed after the study was COMPLETE, then so be it.

I am left questioning if the goal of this trial was to prove that CCSVI doesn’t work as opposed to prove that it DOES work. I am disappointed and I can’t help but feel that my commitment to this study was greater than theirs was, but I am still thankful to have been able to participate.  I guess I will just have to wait for the next “cure” to come along! Until then, I will continue to be my best self every day, while my MS continues to march on!

Raegan