Update

So far, I am doing well with my resolution.  My husband and I have gone to the gym three times per week since signing up at the Y.  Plus, I have done at least 30 minutes of cardio each time! 

In other news, my local NMSS chapter is having a kick-off event for Walk MS season on Tuesday and I have been asked to speak - to tell my story and why I walk.  I have an outline made (not sure I really need it - my story is one that is imbedded in my brain).  I am very excited and honored to speak this year!

Now, in MS news; the following comes from the most recent MSF emailer:

Advanced Technology Makes MS Easier to Track

Using a powerful, triple strength MRI to track increasing levels of iron found in brain tissue, medical researchers at the University of Alberta in Canada have discovered a new way to follow the progression of MS in those living with the disease.
Among their observations: Iron levels in people with MS are increasing in grey matter areas of the brain that are responsible for relaying messages. Also, high iron levels in a specific "relay area" were noted in those who had physical disabilities associated with MS.
Iron is very important for normal function of the brain and the amount of iron is a tightly controlled system by the brain tissue. The discovery suggests there is a problem with the control system. Too much iron can be toxic to brain cells and high levels of iron in the brain have been associated with various neurodegenerative diseases. But to date, no tests have been able to quantify or measure iron in living brain.
Twenty-two people with MS took part in the study, along with 22 people who did not have the condition.
Using this new MRI method would give physicians a new way to measure the effectiveness of new treatments for people with MS by watching the impact on iron levels. This opens up the idea of having a new biomarker, a new way of looking at the disease over time, watching the disease, seeing the progression or lack of progression of the disease, and a new way to track it, the researchers said.
The new MRI method, which uses a machine that is 90,000 times the strength of the earth's magnetic field, will give physicians more detail and information about the impact of MS on the brain, insight that doctors and researchers didn't have before.

Stimulating Natural Interferon-B Production May Combat MS

Some people with MS have successfully slowed progression of the disease using an FDA-approved interferon-b (INFb) medication. Now researchers in Germany are investigating the use of ribonucleic acid (RNA) to stimulate the body’s own production of the IFNb protein, thereby switching off the MS attack.
RNA is one of the three major macromolecules (along with DNA and proteins) that are essential for all known forms of life.
Marco Prinz at the University of Freiburg, Germany, and colleagues took mice genetically modified to present symptoms of MS and injected them with RNA. The mice showed "rapid improvement" with a decrease in tail weakness and paralysis over the following 48 hours. Increased IFNb appeared to slow the development of T-cells - immune cells that may play a key role in MS, the researchers reported.
Around 80 percent of people with MS treated with injections of IFNb develop antibodies that reduce the efficacy of the protein. Getting the body to generate its own IFNb neatly dodges the antibody problem, according to the researchers.

All for now.  Hope all is well!

Happy New Year!

Happy New Year Everyone!  I hope 2012 brings great things!  Hopefully, 2012 will bring the MS community more exciting research, new therapies for ALL types of MS, and leaps closer to a cure.  

In the new year, I resolve to be more active.  My husband and I signed up for a membership with the YMCA.  We had a membership before, but during the time when I was experiencing my first symptoms but before my diagnosis, it became difficult to workout because of the numbness and tingling.  We ended that membership during the fall of 2010, around the time I was diagnosed.  Since then, our "workouts" have mostly consisted of walks around the neighborhood.  Since I have been feeling well for the past year (with a few minor flare-ups in the interim), we decided it was time to get back on the proverbial horse.  I bought a "fitness" swimsuit and plan to do pool workouts to try to avoid heat-induced flare-ups.  Since we signed up a week ago, we have already gone to the Y three times.  I have not started the pool work yet, but plan to this week.  Our NMSS local chapter has a wellness theme this year and in keeping with that, my goal is to get/stay fit and healthy. 

What is your resolution?

In news, researchers have confirmed a link between MS and a gene linked to vitamin D deficiency.  To read more, click here.  I knew that I was smart to be taking vitamin D supplements.  I had my levels checked and was low - I definitely believe that there is a critical link between vitamin D and MS - this research seems to confirm that!

Merry Christmas!

I hope everyone has a very Merry Christmas!  Remember that this is a time to be with family and friends.  Also, while it is easy to get caught up in what we receive, the spirit of the season is giving.  Merry Christmas to all!

Sadness, Bacteria, and Spices

The past few days have been a struggle, but not because of MS.  On Friday, I learned that my grandmother had been taken to the hospital after suffering a heart attack and two brain bleeds.  My husband and I met my mom, dad, and aunt at the hospital and later learned that there was nothing that the doctors could do; they estimated that she would pass within 24 hours.  It was very difficult hearing that news.  My grandmother was a strong woman who always fought through everything and I was initially optimistic that she would fight through this as well; however, it turned out that it was her time.  We said our goodbyes and she passed away Saturday morning.  The weekend was a rough one with many tears and much sadness in my heart.  The funeral was scheduled for Wednesday with a viewing on Tuesday.  I went to work Monday in an attempt to keep my mind off of her death for one day before I took bereavement leave.  However, over my lunch hour, I found her obituary online.  At the end of the obituary, it stated that memorials could be made to her church or the National MS Society.  When I saw that last part, I assumed that the MS Society memorial was an idea of my mom's or something and thought it was a little much.  I inquired of my mom and learned that it was my grandmother's doing; apparently, this past summer, my grandmother had told her pastor that she wanted memorials to go to the MS Society.  When I learned that, I lost it at work; I couldn't believe that my having MS had affected her so much that she would make that request.  My grandmother was one incredibly amazing woman and nothing was more amazing than the immense love that she had for her family.  She will be missed very much, but she will forever be a part of me and she will live on in my heart; for that I am grateful.  I take comfort in knowing that she is in heaven and has been reunited with my grandfather and all those loved ones who went before her.  I think she was ready and I know she led a full life.  Her funeral, while sad, was truly a celebration of her life.  Tuesday and Wednesday was spent among family and it was nice to get together in remembrance.    

Enough of the sadness and onto the MS news . . . . From an MSF mailer:

Friendly Gut Bacteria May Play Role in Triggering MS

Researchers in Germany say they have found evidence that MS is triggered by natural intestinal flora, the so-called friendly bacteria that reside in the gut. Their study involved genetically engineered mice with normal gut bacteria that developed brain inflammation similar to MS in humans. Researchers at the Max Planck Institute of Neurobiology in Martinsried in Munich, Germany published the results of their study in the journal Nature.

The human gut is home to some 100 billion bacteria from 2,000 different species, comprising 10 to 100 times more genes than in our entire genome. These microorganisms not only help us digest food, they are also essential for gut development. And they also play a role in promoting autoimmune disease, say the Max Planck researchers.

In the study, the genetically modified mice were allowed to continue with their normal gut bacteria intact. The intestinal flora were removed in the other mice and they were kept under sterile conditions. The mice that kept their gut bacteria developed MS-like symptoms.

According to the researchers, the bacteria first activated the immune T-cells, then the B-cells, which resulted in an attack on the myelin layer in the brain. The same could happen in humans with a corresponding genetic predisposition, they say.

In their background information, the Max Planck researchers refer to previous research that shows active MS lesions have "inflammatory changes suggestive of a combined attack by autoreactive T and B lymphocytes against brain white matter." (Lymphocytes are the white blood cells of the immune system).

They explain that T and B cells are normally innocuous members of a healthy immune system, but it appears something triggers them to become "autoaggressive"; the cause is commonly assumed to be environmental, with infection being the most common reason given.

One implication of this study is that nutrition may play a key role in the development of MS, since diet largely determines the types of bacteria that colonize the gut. The team now wants to investigate the complete microbial genomes of people with MS and compare them to people without MS.

Neuroprotective Qualities of Indian Spice Studied 

A compound found in saffron, a commonly used Indian spice, is being studied for its potential to help protect brain cells from being damaged in neurological disorders such as MS. Researchers at the University of Alberta in Canada who studied the ingredient, crocin, in lab models and cell cultures found that it appears to prevent damage to cells that make myelin in the brain.

The researchers detailed their study in The Journal of Immunology, noting that they are not yet close to a clinical trial stage. The team discovered that inflammation and a specific type of cell stress are closely linked and lead to inflammation and neurodegeneration, which cause cells to lose their protective coating – a process known as demyelination.

In experiments, they found the use of crocin suppressed both inflammation and this specific type of cell stress, resulting in decreased neurological impairment in lab models and cell cultures with MS.

"There are still many questions to be answered about how crocin exerts these neuroprotective effects, but this research highlights a potential treatment role for crocin in diseases involving chronic neuroinflammation – something that had not been recognized until now," the researchers stated.

Staying optimistic and intrigued by the constant research!  Thanks for reading!

Long Time, No Post

Sorry for the recent delay in posting.  I hope everyone had a Happy Thanksgiving!  My whole family got together which was great!  I have kept very busy lately, so I haven't had many chances to get on here to post.  Also, our computer got a virus, so we had to fix that before I could post.

And now, some news from the NMSS website:

The company Opexa Therapeutics (The Woodlands, TX) announced that the experimental therapy Tovaxin® has been designated by the U.S. Food and Drug Administration as a “Fast Track Product” for the treatment of secondary-progressive MS. Tovaxin is a personalized vaccine that aims to induce immunity against T cells that attack the brain and spinal cord in MS. It uses a person’s own immune cells, which are removed, manipulated, and then reintroduced by under the skin injections. The Fast Track designation may expedite its future review by the FDA after the company submits results of future phase III trials. The company is planning to begin a Phase IIb clinical trial of Tovaxin in secondary-progressive MS “subject to securing the necessary resources,” according to a November 8, 2011 press release.
Results so far: A one-year, multi-center trial of Tovaxin was conducted in 140 people with relapsing-remitting MS and 10 people who had experienced a neurological episode that put them at possible risk for being diagnosed with MS. The TERMS study found Tovaxin to be safe, but did not achieve statistical significance in the primary endpoint evaluating the cumulative number of active MRI lesions in those on active therapy versus those on placebo (Multiple Sclerosis, published online November 6). Analyzing a subset of participants after the study, investigators found that Tovaxin stabilized or reduced disability as measured by the EDSS scale, and the average number of relapses in a year.
Tovaxin is a trademark of Opexa Pharmaceutics.

This is VERY exciting because its focus is secondary-progressive MS rather than relapsing-remitting, which is what most therapies treat. Another article off of the NMSS website:

Genzyme has announced that the experimental intravenous therapy alemtuzumab (with a proposed brand name Lemtrada™) met two primary endpoints by significantly reducing relapse rates and the worsening of disability in a two-year study comparing alemtuzumab to standard subcutaneous dosing of Rebif® (interferon beta-1a, EMD Serono Inc. and Pfizer). The study, called CARE-MS II, involved 840 people with relapsing-remitting MS. The results were announced in a November 14, 2011 press release, which also indicated that the company plans to apply in early 2012 to the U.S. Food and Drug Administration for marketing approval. Data analysis is ongoing and the company expects to provide a full report at an upcoming medical meeting. Alemtuzumab has been designated by the FDA as a “Fast Track Product,” which should expedite its future review.
Background: MS involves immune system attacks against brain and spinal cord tissues. Alemtuzumab is a humanized monoclonal antibody directed at CD52 (a protein on the surface of immune cells) that is currently approved for the treatment of B-cell chronic lymphocytic leukemia. Its ability to target immune cells led investigators to test its potential as a treatment for relapsing-remitting MS. In an earlier phase II study comparing two dose levels of alemtuzumab with Rebif in 334 subjects with relapsing-remitting MS, those taking alemtuzumab had a 74% reduction in the risk of MS relapse compared with those on Rebif, and a 71% reduction in the risk for sustained worsening of disability (New England Journal of Medicine 2008 359;17:30-45).
Dosing was temporarily suspended in the Phase II study due to the occurrence of immune thrombocytopenic purpura (ITP), a rare condition in which low blood platelet counts can lead to abnormal bleeding. After the first cases of ITP occurred, one of which was fatal, Genzyme implemented a patient safety monitoring program which includes patient and physician education and regular contacts with patients.
Investigators recently reported on another phase III trial of alemtuzumab. The two-year CARE-MS-I phase III trial compared alemtuzumab against Rebif in 581 people with early relapsing-remitting MS. The study met one of two primary endpoints by reducing relapse rates by 55% over Rebif, but did not meet its second primary endpoint of slowing disease progression compared to Rebif. (Abstract #151, ECTRIMS 2011)
This Study: In the CARE-MS II study, 840 people with relapsing-remitting MS, who had experienced relapse while on a prior therapy, were randomly assigned to receive alemtuzumab or Rebif. Alemtuzumab was given by intravenous infusion for 5 days initially and for 3 days one year later. Those on Rebif received the standard dose of 3-times weekly subcutaneous injections. According to the company press release, after two years the relapse rate of those on alemtuzumab was reduced by 49% compared to those on Rebif, and the risk of sustained worsening of disability (as measured by the EDSS scale) was reduced by 42% compared to Rebif. (These were the primary endpoints of the study.)
According to the press release, approximately 16% of those treated with alemtuzumab developed autoimmune thyroid-related problems and approximately 1% developed ITP. All cases were detected early through a monitoring program and managed with conventional therapies. Other common adverse events associated with alemtuzumab included reactions associated with infusions (such as headache, rash, fever, flushing, hives and chills). The most common infections in those treated with alemtuzumab (all mild to moderate) were upper respiratory and urinary tract infections, sinusitis and herpes simplex infections.
Comment: The completion of this second Phase III trial of alemtuzumab is a milestone that paves the way for the company to apply to the FDA for marketing approval. Full details and evaluation of this study should help define the safety and promise of alemtuzumab as a potential new therapy for relapsing MS.

Love the ongoing research; I remain optimistic that a cure will come in my lifetime!  So many advances have been made in just the past decade alone!

Happy Veteran's Day + BG-12 Update

First, I want to thank the veterans for their service and dedication to our country, our safety, and our freedom!  

With that said, I attended an MS dinner/presentation last night about Stress and MS.  I cannot say that I really learned anything new, but it was a good reminder to keep stressors in check and to be sure to have a good coping system.  Life is stressful, MS adds extra stress, and we need to be able to have coping mechanisms in place to minimize the affects of stress.

Now for the BG-12 update (from the NMSS website):

Biogen Idec announced that the experimental oral therapy BG-12 significantly reduced the average number of annual MS relapses in a two-year, Phase III clinical trial of more than 1400 people with relapsing-remitting MS. Although its exact mode of action is not known, BG-12 is thought to inhibit immune cells and molecules involved in MS attacks on the brain and spinal cord. The results of the CONFIRM study were announced in an October 26 press release. Data analysis is ongoing and the company expects to provide a full report at an upcoming medical meeting. Positive results from another Phase 3 trial of BG-12 were also announced this year, paving the way for a potential application for marketing approval.

Background: Multiple sclerosis involves immune system attacks against brain and spinal cord tissues. Although its exact mechanism of action is not known, BG-12, an oral drug, is thought to inhibit immune cells and molecules and may be protective against damage to the brain and spinal cord. In an earlier phase II study, compared to inactive placebo, the highest tested BG-12 dose led to a 69% reduction in gadolinium-enhanced (a contrast agent) disease activity on MRI scans from weeks 12 to 24. Earlier in 2011, Biogen Idec announced positive results in another phase III study, the DEFINE trial. Further details on these results were presented at the joint meeting of the European and Americas Committee for Treatment and Research in MS (ECTRIMS/ACTRIMS) last week.

This Study: The primary goal of the CONFIRM study was to determine whether BG-12 could reduce the average annual MS relapse rate at two years. Secondary objectives included assessing BG-12’s effects on the proportion of people who had relapses, disability progression, and disease activity detected by MRI. Safety and tolerability were also assessed.
Participants were randomly assigned to one of two treatment groups receiving different oral doses (240 mg twice each day and 240 mg three times each day), a group receiving glatiramer acetate (Copaxone®, Teva Pharmaceutical Industries, an approved, injected therapy for MS) or a group receiving placebo. Both BG-12 groups and Copaxone were compared to the placebo groups, but not to each other.

According to the press release, in both groups taking BG-12, the primary endpoint was met; the average number of MS relapses in a year was reduced by 44% versus placebo in the lower-dose group, 51% in the higher-dose group, and 29% in the Copaxone group. Disease activity on MRI and the proportion of patients experiencing relapses also were reduced significantly more in the BG-12 groups versus placebo. Disability progression was not reduced significantly more in the BG-12 groups than in the placebo group. According to the press release, the most common adverse events in the BG-12 groups were flushing and gastrointestinal events.

Comment: Full details and evaluation of this study should help to define further the safety and promise of BG-12 as a potential therapy for relapsing MS. According to the company press release, these positive results set the stage for upcoming filings for marketing approval from drug regulatory agencies.

It is so exciting to learn that another oral therapy is doing well!  Hopefully soon, injections will be a thing of the past for all of us.  In the meantime, stick with what works.

New News from MSF

In this post: How cool would it be if MS could be diagnosed just by exhaling, BG-12 is showing progress, and odd hours may be a increase the risk of MS in teens, and should we be discussing walking problems with our doctors more?

The following is from my most recent email from the Multiple Sclerosis Foundation.

Diagnosing MS from Exhaled Breath

Scientists are reporting the development and successful tests in humans of a sensor array that can diagnose MS from exhaled breath, an advance that they describe as a landmark in the long search for a fast, inexpensive, and noninvasive test for MS. Their report appears in the journal ACS Chemical Neuroscience.

Hossam Haick and colleagues report have identified volatile organic compounds that can be associated with MS from exhaled breath. Based on these findings, the researchers developed a new sensor array that can diagnose MS by analyzing the determined chemical compounds that appear in the breath of people with MS. Using the developed sensors, the researchers carried out a proof-of-concept clinical study on 34 people with MS and 17 healthy volunteers and found that the developed sensors are just as accurate as a spinal tap but without the pain or the risk of side effects. 

"The results presented here open new frontiers in the development of fast, noninvasive, and inexpensive medical diagnosis tools for detection of chronic neurological diseases," the scientists stated. "The results could serve as a launching pad for the discrimination between different subphases of stages of multiple sclerosis as well as for the identification of multiple sclerosis patients who would respond well to immunotherapy." 

A large clinical study with the sensors is underway and will be reported in the future. Haick is a Professor in the Department of Chemical Engineering and the Russell Berrie Nanotechnology Institute at the Technion – Israel Institute of Technology. 

BG-12 Moves Forward with Positive Data from Late-Stage Trials
Positive top-line results have been reported from CONFIRM, the second of two pivotal phase III clinical trials designed to evaluate the investigational oral compound BG-12 (dimethyl fumarate) in people with relapsing-remitting multiple sclerosis (RRMS). Results showed that 240 mg of BG-12, administered twice a day (BID) or three times a day (TID), demonstrated significant efficacy and favorable safety and tolerability profiles. Further analyses of the CONFIRM study are ongoing, and Biogen Idec, the company developing BG-12, anticipates presenting detailed data at a future medical meeting.

BG-12 met the CONFIRM study's primary endpoint by significantly reducing annualized relapse rate (ARR) by 44 percent for BID and by 51 percent for TID versus placebo at two years. The CONFIRM study's reference comparator, glatiramer acetate (GA; 20 mg subcutaneous daily injection), reduced the ARR by 29 percent compared with placebo at two years. 

Initial results showed that BG-12 reduced 12-week confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS) by 21 percent for BID and 24 percent for TID at two years compared to placebo, and GA reduced confirmed disability progression by 7 percent. 

"We now have strong positive results for BG-12 in two robust pivotal clinical trials with more than 2,600 patients," said Doug Williams, Ph.D., Biogen Idec's Executive Vice President of Research and Development. "We are gratified by these strong efficacy and safety results, which, when combined with BG-12's oral route of administration, position it as a potentially important MS therapy. We are working aggressively to prepare our regulatory submissions with the goal of making BG-12 available to MS patients as quickly as possible." 

In CONFIRM, both dose regimens of BG-12 showed favorable safety and tolerability profiles, which were similar to those seen in the previous late-stage study known as DEFINE. Overall, the incidence of adverse events (AEs), serious adverse events (SAEs) including serious infections, and discontinuations due to AEs were similar across all study groups, including placebo. The incidence of hepatic and renal events was also comparable among all study groups. The most common AEs in the BG-12 groups were flushing and GI events. There were no malignancies in the BG-12 groups. 

Biogen Idec presented data from DEFINE, at the 5th Joint Triennial Congress of the European and Americas Committees on Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) in October 2011.

 

Working Overnight or Odd Shifts May Increase MS Risk in Teens

Working overnight or odd shifts may increase teenagers' risk of developing MS, according to the results of an observational study. 

Researchers from Sweden who uncovered the link said interruption of circadian rhythms and disruption of normal sleep patterns may be partially responsible for the added risk.

In conducting the study, published in the Oct. 18th issue of Annals of Neurology, researchers examined two population-based studies of Swedish residents aged 16 to 70 (one with incident cases and one with prevalent cases) to compare the number of cases of MS among those who did and did not work overnight or shift hours on a regular or alternating basis during their teens.

Among the incident cases, the investigators found those who worked overnight hours for three years or more before the age of 20 were twice as likely to develop multiple sclerosis as those who never worked night shifts. Among the prevalent cases, they noted, the teens who worked overnight hours were slightly more than twice as likely to develop the disorder.

"Our analysis revealed a significant association between working shift at a young age and occurrence of MS," Dr. Anna Karin Hedstrom, of the Karolinska Institute in Stockholm, said in a journal news release. "Given the association was observed in two independent studies strongly supports a true relationship between shift work and disease risk." 

The researchers explained the sleep restriction associated with working the night shift has already been shown to increase the risk for certain health problems, including heart disease, thyroid disorders and cancer, likely by interfering with melatonin secretion and increasing inflammatory responses. 

The authors pointed out that since MS is a central nervous system autoimmune inflammatory disorder that is linked to a person's environment, other lifestyle risk factors, such as sleep loss due to shift work, should also be considered.

The study authors noted that more research is needed to explain why the disruption of circadian rhythm and sleep loss increase teenagers' risk for developing MS.

 

MS Walking Problems Rarely Discussed

Most people with MS who have difficulty walking say it is the most challenging part of the debilitating disease, U.S. researchers say. However, a survey by Harris Interactive indicated 40 percent of people with MS rarely or never discuss walking problems with their doctor. 

The recent survey of more than 1,200 adults living with MS indicated 65 percent reported having trouble walking, the inability to walk, or difficulty maintaining balance at least twice per week. Seventy percent of those with walking issues say that's the toughest symptom to deal with.

In addition, a majority of people living with MS reported they experienced walking problems within the first few years after diagnosis, while among people diagnosed with MS within the past five years, 58 percent reported experiencing a mobility issue at least twice a week.

On average, people with MS ages 41 or younger who do discuss trouble walking with their doctor initiate the conversation only 46 percent of the time. An estimated 78 percent of these women and 62 percent of these men report that trouble walking makes getting around dangerous, the survey indicated.

In light of the increasing menu of therapeutic options, assistive technology, and medication to aid walking problems, conversations with your doctor may lead to solutions.

 

As always, the ongoing studies and research is much appreciated!  Being able to diagnose MS with just a breath is incredible!  Disruption of normal sleep habits increasing the risk of MS makes me reevaluate my sleeping habits and makes me think back to my teenage sleep patterns (probably not the best, but what teenager truly has good sleeping habits?).  I am always happy to hear that clinical trials are going well for up and coming therapies!  Go BG-12!  

Thanks for reading!  Hope everyone is well!

Comments & a CCSVI Update

I want to take a moment to thank everyone who has left a comment on this blog!  It is so amazing to know that people are reading and that my blog has an impact.  I think I had forgotten that, to some extent, until my last post (Too Long).  In response to that post, I got two very kind, very supportive, very positive comments.  It reminded me of why I started this blog and it reminded me that everyday is a blessing and that I need to stay optimistic.  Your comments lift my spirit and I appreciate your words!  I am so lucky to have such an amazing support system, from my family to my friends to the readers of my blog.  It warms my heart to know that people whom I have never met support me.  It is also always great to hear about other people's experiences with MS; it helps me remember that I am not alone in this fight and that there are so many people to be fighting for.  I hope and pray that someday soon we will have a cure.  Thanks again for your continued support and for your always appreciated comments!

And now . . . a CCSVI update from the MSAA:

Background Information on CCSVI and MS

Many questions still surround the possible connection between chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis (MS). CCSVI is a complex condition involving changes in blood flow from the brain back to the heart, which some researchers theorize could possibly lead to activation of the immune system, excess iron deposits, loss of myelin, and other nervous system damage. With CCSVI, the veins located on the outside of the brain (extracranial cerebrospinal veins) - those designed to transport blood from the brain back to the heart - collapse and/or become blocked, a condition known as "stenosis." Studies have shown that when the normal blood flow is altered, especially when the flow of blood is reversed, the body may react with an inflammatory response.
Two years ago, Paolo Zamboni and others published the results of a pilot study in the December 2009 edition of the Journal of Vascular Surgery. In this article, lead investigator Dr. Zamboni describes an experimental procedure to widen the narrowed or blocked veins in a study of 65 MS patients. Some refer to this as the "liberation procedure," where angioplasty is performed using a tiny balloon inserted into an affected vein. From this small, open-label study, Dr. Zamboni noted that a portion of the patients with relapsing-remitting MS (RRMS) experienced fewer relapses and improvement in function.
Since these results were published, the CCSVI theory in MS has received a great deal of attention. While a small number of studies are underway, some MS patients are seeing vascular surgeons or interventional radiologists on their own to undergo speculative diagnostic and corrective procedures. Additionally, vascular specialists and neurologists are not always in complete agreement about the presence of this condition in patients with MS and the procedures.
Anecdotally, some individuals with MS who have undergone a procedure feel that they are experiencing some improvement in certain symptoms. Typically, these might include improvements in fatigue, heat sensitivity, sleep, concentration, and balance. Over time, some even attribute improvements in bladder issues, mobility, flexibility, and other symptoms to the procedure. Conversely, some patients did not see any improvement following the procedure.

Research Challenges with CCSVI and MS

The problem faced by the medical community in researching the CCSVI theory is two-fold. First, researchers need to prove whether or not CCSVI occurs more often in individuals with MS versus the general population, and if so, how it may be related to the disease. Further complicating the issue is the fact that no single procedure or protocol has been identified for its diagnosis, and a wide range of results can occur when using different imaging equipment, techniques, and technicians.
The second problem in researching the CCSVI theory involves treating the condition. Dr. Zamboni and others have used an angioplasty-type of treatment for opening closed veins with a tiny balloon that is inflated several times and then removed. Possible adverse events can include bleeding, heart arrhythmias, and rarely an allergic reaction to the dye used to illuminate the veins. Additionally, veins sometimes close (restenosis) in the months following the procedure. A second option is to insert a stent into the closed veins, which poses additional risks - such as the stent dislodging and moving to another area of the body - requiring immediate surgery. Even with the stents, scar tissue can sometimes form and clog the stent. Finally, doctors will still need to determine if and to what extent MS patients may benefit from such a procedure, and if the benefits outweigh the risks.
More than 50 articles on the subject have appeared in peer-reviewed publications over the past two years, although many present conflicting results - with some finding significant proof of CCSVI in MS patients, and others finding no evidence - a problem often blamed on the lack of a protocol for specific diagnosis. Doctors are also looking at possible relationships between CCSVI and known risk factors for MS, including Epstein-Barr virus, genetic factors, Vitamin D deficiency, and cigarette smoking.
Experts agree that a strict protocol for testing will need to be developed, that a combination of tests may be required for a confirmed diagnosis of CCSVI, and that the operators performing these tests will need specialized training for consistent results. Another impressive hurdle in these studies is the issue of blinding. The researchers, doctors, and operators performing the diagnostic tests and evaluating the patients after the procedures need to be blinded as to who has MS and who received the active treatment, or the results could be biased.

Current Studies and CCSVI Registry

Studies may be found by visiting www.clinicaltrials.gov and searching for "CCSVI and multiple sclerosis." Many of the studies are listed as still recruiting participants, but interested individuals should check with the contact person listed for the most current information on recruitment. Currently, seven studies are listed, with locations in New York, Texas, California, Poland, and Italy. In June 2011, the Canadian Institutes of Health Research announced that they will be proceeding with a Phase I/II clinical trial.
One of the studies listed is sponsored by the Hubbard Foundation, titled, "Multi-center Registry for CCSVI Testing and Treatment." Located in San Diego, California, the purpose is to develop a registry of patients evaluated and treated for CCSVI, looking at changes in quality of life. The Hubbard Foundation is looking for doctors and medical facilities that perform CCSVI testing and treatment to register under their IRB (Institutional Review Board) approval to conduct research and provide the outcome of those tested and treated for CCSVI.
In June 2010, the National MS Society and the MS Society of Canada committed more than $2.4 million to support seven new research projects focusing on the role of CCSVI in MS.

Closing Remarks

As with any unproven theory and treatment, interested patients are strongly encouraged to talk with their doctor, and if appropriate, participate in an approved clinical trial. Without a tested and proven protocol for the diagnosis and treatment of CCSVI, individuals could be putting themselves at risk. In July 2011, news arrived of a second individual with MS from Canada who sought treatment outside of the country and died due to complications. Although such tragic results are not common, individuals considering these types of procedures should be aware of the risks involved.
MSAA enthusiastically but cautiously supports the investigation of potential causes and treatments for MS, striving to communicate such research to the MS community as soon as any information becomes available. However, MSAA's policy is to consider patient safety as the top priority - recognizing that all prospective theories and experimental treatments need to be thoroughly studied through rigorous clinical trials.

For more information on CCSVI from the MSAA, visit the MSAA's news center.

Thanks for reading!

Too Long

It has been too long since I last posted and, for that, I am sorry.  I have been a little down lately and I haven't had the motivation to post.  I guess I am finally realizing what it means to have relapsing-remitting MS.  I have been experiencing some numbness, tingling, and L'Hermittes intermittently lately and it has been frustrating.  I had been doing very well with little to no symptoms at all, but lately I have noticed some flare ups.  I am still much better off than I could be and I am grateful for that, but I was really enjoying being in complete remission.  Relapses suck, even the less severe relapses.  My "flare ups" have not been particularly bad (nothing like my symptoms before beginning treatment), but they are noticeable, which is enough to put me in a bit of a funk. 
I did go for a run for the first time since my diagnosis.  I am trying to get back into a workout routine so I went for a jog and my entire lower half was numb by the end, plus I was experiencing L'Hermittes pretty bad.  Will continue to jog for awhile and hope that my symptoms don't get any worse.  I just need to stay as cool as possible (with winter on the way, that shouldn't be too difficult). 

In other news, a dog park just opened up about 2.5 miles from our house, so we took our puppy there today.  He was in doggy heaven; he loves playing with other dogs.  He listened well and played nice, so it was definitely a success!  We will have to take him back soon.

Enough about me.  A recent study found that "subjects who were born by Caesarean section had a significantly higher risk of developing MS. The authors conclude that their results suggest those born by vaginal delivery are at a lower risk of subsequent MS, but that much larger and preferably prospective studies are needed."  This is very interesting to me; I am not sure how this would affect risk of developing MS, but apparently it may be a contributing factor.

For a limited time only, every donation made to the NMSS is doubled. Go to the NMSS website today to make a donation!!!

Follow up - MSF News

Now, more from the MSF email:

FDA Approves Botox to Treat Urinary Incontinence with MS

The U.S. Food and Drug Administration has approved Botox® (onabotulinum toxin A) injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder.

Uninhibited urinary bladder contractions in people with some neurological conditions can lead to an inability to store urine. Current management of this condition includes medications to relax the bladder and use of a catheter to regularly empty the bladder. The approved treatment consists of Botox being injected into the bladder resulting in relaxation of the bladder, an increase in its storage capacity, and a decrease in urinary incontinence.

"Urinary incontinence associated with neurologic conditions can be difficult to manage,” said George Benson, deputy director, Division of Reproductive and Urologic Products. “Botox offers another treatment option for these patients."

Injection of the bladder with Botox is performed using cystoscopy, a procedure that allows a doctor to visualize the interior of the bladder. Cystoscopy may require general anesthesia. The duration of the effect of Botox on urinary incontinence in people with bladder overactivity associated with a neurologic condition is up to 10 months.

The effectiveness of Botox to treat this type of incontinence was demonstrated in two clinical studies involving 691 patients. The participants had urinary incontinence resulting from spinal cord injury or MS. Both studies showed statistically significant decreases in the weekly frequency of incontinence episodes in the Botox group compared with placebo.

In addition to its use to improve the appearance of facial frown lines, Botox also is FDA-approved to treat chronic migraine headaches, certain kinds of muscle stiffness and contraction, severe underarm sweating, abnormal twitch of the eyelid, and a condition in which the eyes are not properly aligned.

The most common adverse reactions observed following injection of Botox into the bladder were urinary tract infection and urinary retention. Those who develop urinary retention after Botox treatment may require self-catheterization to empty the bladder.

Botox is marketed in the United States by Allergan Inc., of Irvine, Calif. 

Laquinimod Faces Hurdles
Teva Pharmaceutical Industries, Ltd. faces growing challenges and uncertainty surrounding its MS treatments, according to an Oppenheimer analyst.

The Israeli drugmaker said that its experimental drug, laquinimod, an oral MS treatment, did not reduce patients' annual relapse rates in a late-stage clinical trial. The study involved 1,331 patients who were treated with one of three options: laquinimod, a placebo, or Avonex, an older MS drug made by Biogen Idec, Inc.

Teva said MRI scans showed the patients in the laquinimod and Avonex groups had more brain lesions, which indicates they had more severe multiple sclerosis, and if study results are adjusted to remove that imbalance, laquinimod met its main goal of lowering the relapse rate.

Teva and its partner Active Biotech still plan to seek approval of laquinimod in the U.S. and the European Union. In December, the companies said the drug met its main goal in its first late-stage trial.

Analyst Christopher Holterhoff said in a research note it is unclear whether the U.S. Food and Drug Administration will accept adjusted data from the latest study as meaningful or require Teva to run another study.

"We are unaware of a precedent case where an MS drug was approved without two statistically significant trials," the analyst wrote.

Free Smartphone App Helps Keep Track of Injections
A free smartphone app, TrackMyShots, is available to help ease the log-keeping of people with MS, diabetes, and other conditions requiring frequent injections.

The app eliminates the need for bulky log books by allowing the user to record each injection, track injection sites, and monitor adverse reactions. Users can set up an ongoing schedule for their injections and get email alerts when it is time for their next shot.

Developed by Linxter, Inc., a software development company in Cooper City, Fla., the app was created to help a family friend with MS, says company CEO and founder Jason Milgram.

“She had carried around a bulky paper logbook for years,” Milgram said. “She and her husband asked if I could help develop an app that would allow her to keep track of the injections.”

The app’s initial release is available for Windows Phone 7 users. An Android version was scheduled to be available in late August, and iPhone users will be able to access the app in late September.

TrackMyShots, http://trackmyshots.com, recently received a Hero of the Week award from Microsoft, which “honors excellence in the field of app development.”

Definitely going to look into that app!  It looks as though Gilenya may continue to be the only available oral treatment for awhile.