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Thursday, July 6, 2017

Effects of a multimodal intervention on gait and balance of subjects with progressive multiple sclerosis: a prospective longitudinal pilot study


                                                                  
  
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Video abstract presented by Terry L Wahls.
Views: 52
Babita Bisht,1,2 Warren G Darling,2 Emily C White,2Kaitlin A White,2 E Torage Shivapour,3 M Bridget Zimmerman,4 Terry L Wahls1,5

1Department of Internal Medicine, Carver College of Medicine,2Department of Health and Human Physiology, UI College of Liberal Arts and Sciences,3Department of Neurology, Carver College of Medicine, 4Department of Biostatistics, College of Public Health, University of Iowa, 5Department of Extended Care and Rehabilitation Service Line, Iowa City VA Health Care System, Iowa City, IA, USA

Purpose: To investigate the effects of a multimodal intervention including a modified Paleolithic diet, nutritional supplements, stretching, strengthening exercises with electrical stimulation of trunk and lower limb muscles, meditation and massage on walking performance and balance of subjects with progressive multiple sclerosis (MS).

Materials and methods: Twenty subjects with mean (standard deviation) age of 51.7 (6.4) years and Expanded Disability Status Scale score of 6.2 (1) participated in a 12-month study. Assessments were completed at baseline, 3, 6, 9, and 12 months.

Results: The entire cohort did not show significant changes in any of the assessments over 12 months except higher speed of walking toward the 10 feet mark during timed up and go (TUG) test at 6 months compared with baseline (mean change 7.9 cm/s [95% confidence interval {CI}]: 0.3, 15.2; p=0.041). Sub-group analysis revealed that 50% subjects (n=10) showed decrease in TUG time from baseline to at least 3 of 4 time-points post-intervention and were considered as responders (TUG-Res), the remaining 10 subjects were considered as nonresponders (TUG-NRes). Over 12 months, TUG-Res showed decreased mean TUG time by 31% (95% CI: −52%, −2%), increased median Berg Balance Scale scores (42 to 47), 30% increase in mean timed 25-foot walk speed (>20% considered clinically significant) and increased speed of walk toward 10 feet mark during TUG by 11.6 cm/s (95% CI: −3.0, 25.9) associated with increases in step lengths and decrease in step duration. TUG-NRes showed deterioration in walking ability over 12 months. Comparison of TUG-Res and TUG-NRes showed no significant differences in adherence to intervention but better stride duration and longer step length at baseline for TUG-Res than for TUG-NRes (p<0.05).

Conclusion: A multimodal lifestyle intervention may improve walking performance and balance in subjects with progressive MS who have mild-to-moderate gait impairment, whereas subjects with severe gait impairments may not respond to this intervention. Future trials should assess effects of this intervention in subjects with MS during early stages of the disease.


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Wednesday, July 5, 2017

Learn more about research on the immune system in MS


                                                                  
  
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Understanding and stopping MS in its tracks requires a better understanding of the role that the immune system plays in this disease. This system is involved both in the inflammatory attacks on myelin and, very possibly, in the injury to axons (the wire-like nerve fibers) that contributes to longer-term disability. Research on the immune system includes studies on:
  • Understanding components of the immune system such as T cells, B cells, and antibodies
  • Identifying new targets for therapeutic intervention while leaving the rest of the immune system capable of fighting infections
  • Identifying substances and processes involved in the injury of axons
  • Identifying the body’s natural immune messenger molecules that can either turn on or turn off immune attacks
Significant progress is being made in understanding the immune system's involvement in MS, which will help drive breakthrough solutions to change the world for everyone with MS. 

We’re making progress

Studies of the immune system in MS laid the groundwork for every disease-modifying therapy now available, and these studies continue to hold promise for finding ways to stop MS. Here are reports of recent progress:

Decades of Basic Research Pay Off with Early Clinical Trial of Immune Therapy 
An international team has reported results of a small, early clinical trial involving 10 people with relapsing or secondary-progressive MS. The trial tested the feasibility and safety of using a patient’s own altered blood cells to reduce immune responses against specific components of myelin, the nerve covering that is a key target of immune attacks in MS. Treatment appeared safe and showed signs of reducing immune responses to myelin, This is one example of how the Society’s long-term investment in basic research that has relevance to MS pays off. Read details here.
 
Immune system may drive cognitive changes in MS
Memory impairment and other cognitive changes are experienced by many people with MS, but the details of how this occurs are not clear. Now researchers supported in part by the National MS Society report evidence that a group of immune system proteins called “complement” may play a role in the loss of nerve connections (synapses) in the hippocampus, a part of the brain linked to memory. Read more
 
Distinguishing between 'good' and 'bad' immune cells
A team funded by the National MS Society has shed new light on immune cells known as macrophages, and how one type of these cells may play a significant role in launching damage in MS. The researchers have discovered a way to differentiate between good and bad types of these immune cells active during MS-like disease in mice, and if further research shows that these findings hold true for people with MS, this opens up possibilities for developing therapies that target the bad cells and spare the good cells. Read more


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Researchers Find That Immune B Cells from People with MS May Harm Nerve Cells


                                                                  
  
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July 5, 2017
SUMMARY:
  • Researchers co-funded by the National MS Society have found that immune B cells obtained from the blood of people with relapsing-remitting MS secrete products that can be toxic to nerve cells grown in lab dishes.
  • This study offers new insight into how B cells may contribute to nervous system damage in MS.
  • The team is now conducting further studies to identify the toxic factor or factors secreted by the B cells, and when and how they may act in people with MS, and to answer questions such as whether they are unique to MS, whether they are also evident in people with progressive MS.
  • Drs Robert P Lisak, Joyce Benjamins (Wayne State University), Amit Bar-Or (McGill University and currently at University of Pennsylvania) and colleagues published their findings in the Journal of Neuroimmunology (2017 Aug 15;309:88-99, published online May 17) 
DETAILS
Background: While scientists still don’t know what causes multiple sclerosis, they do know that immune-system attacks are involved, resulting in damage to the myelin that insulates nerve fibers and to nerve cells and fibers themselves. Immune T cells have typically been named as culprits, but it has become clear that immune B cells, another type of white blood cell, are also involved in MS. Research and studies on B cells, including early studies supported by the National MS Society, eventually led to successful clinical trials and approval of Ocrevus™ (ocrelizumab - Genentech, a member of the Roche Group) to treat people with primary progressive and relapsing-remitting MS. Ocrevus depletes certain B cells.
 
The Study: The current study builds on the researchers’ earlier findings that B cells from the blood of people with relapsing-remitting MS – but not blood from healthy individuals – are toxic to certain cells that build myelin. In this study, the team isolated B cells in the laboratory from the blood of 13 women and men with relapsing-remitting MS who were not receiving disease-modifying treatment or recent steroids, and 13 controls without MS.
 
The researchers found that products released by B cells from the people with MS were toxic to both rat and human nerve cells grown in lab dishes, while cells from the controls did not incur the same damage. The nerve cells died from apoptosis – a type of self-destruct program – and not, as might be expected, from cell disintegration, or from immunoglobulins (antibodies) that have been identified as culprits in the MS attack.  
 
Drs Robert P Lisak, Joyce Benjamins (Wayne State University), Amit Bar-Or (McGill University and currently at University of Pennsylvania) and colleagues published their findings in the Journal of Neuroimmunology (2017 Aug 15;309:88-99, published online May 17). This study was supported by the National MS Society (USA), the Research Foundation of the MS Society of Canada, and others.
 
Next Steps: This study offers new insight into how B cells may contribute to nervous system damage in MS. The team is now conducting further studies to identify the toxic factor or factors secreted by the B cells, and when and how they may act in people with MS. They are using “proteomics” for this work, advanced technologies the can identify and quantify numerous molecules simultaneously, along with other approaches. They also plan to answer questions such as whether the toxic B cells are unique to MS or are found in other immune mediated disease, which subsets of B cells produce the toxic effects and whether they are also evident in people with progressive MS.
 
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Another MS Symptom: Sciatic Nerve Pain at a Whole New Level


                                                                  
  
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Another MS Symptom: Sciatic Nerve Pain at a Whole New Level

Published July 5, 2017 by Debi Wilson

Just when I thought I had experienced every multiple sclerosis (MS) symptom possible, another one emerges: sciatic nerve pain. It can happen to anyone, but it is also associated with MS.
A couple of months ago, I woke up with a sharp knife-type pain on the upper back side of my left leg. All I could wonder was “What is MS doing to me now?”
Usually doing stretches while lying on my bed alleviated any sciatic nerve pain I had. I bent my left leg up to meet my chest, then lifted it over my body. Next I held my left foot with my right hand for about 20 seconds. Then I completed the move by stretching my leg out straight and flexing my foot.
I learned to live with sciatic pain. When it showed up, I did my stretches, or walked it off, but now it is moving in a whole new direction. The sciatic nerve, by the way, is the longest in the body, running from the lower back to the tops of the feet.
The other day I went to get up out of my chair, and had the worst burning pain in the same area where the sharp pain was. It felt as if someone were poking me with a red-hot poker! It attacks me every time I go to stand, and sometimes when I’m trying to sit.
A Multiple Sclerosis Society of New Zealand article, “Multiple Sclerosis and Pain,” written by Anne McAuley and by Dr. Rosemary White, explores a theory on what causes the sciatic pain in MS. The article says most pain with MS is due to immobility or poor posture instead of damaged nerves. The article says immobility, or sitting in a wheelchair for a long time, puts pressure on the nerves in the back of the legs that generates sciatic pain.
The contention that pain is related to immobility or poor posture sounds reasonable to me. In fact, I was sitting in my wheelchair for almost three hours before this week’s burning sensation appeared. Being in the wheelchair for that long was not the best scenario for me. I should have been in a regular chair, and moving around from time to time, instead of sitting that long.
READ MORE


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Tuesday, July 4, 2017

Complimentary & Alternative Therapy for MS


                                                                  
  
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Alternative therapy encompasses a variety of disciplines that range from diet and exerciseto mental conditioning to lifestyle changes. Examples include acupuncture, yoga, aromatherapy, relaxation, herbal remedies, and massage.
Complementary therapies are alternative therapies used in addition to traditional treatments. For example, you may have weekly massages to complement your drug treatment.

What is recommended for MS?

  • Positive attitude. Having a positive outlook cannot cure MS, but it can reduce your stress and help you feel better.
  • Exercise. Exercises such as tai chi and yoga can lower your stress, help you to be more relaxed, and increase your energy, balance, and flexibility. As with any exercise program, check with your doctor before getting started.
  • Diet. It is important for people with MS to follow a healthy, well-balanced diet. Ask your doctor what diet is right for you.

What are some alternative/complementary therapy options for MS?

  • Massage. Many people with MS receive regular massage therapy to help relax and reduce stress and depression, which can exacerbate the disease. There is no evidence that massage changes the course of the disease. It is usually safe for people with MS to receive a massage, but if you have bone-thinning osteoporosis (usually as a result of your treatments), massage may be dangerous. Talk to your doctor first.
  • Acupuncture. Some people with MS report that acupuncture provides some relief of symptoms such as pain, muscle spasms, or bladder control problems. There have been no scientific studies to confirm this or to document that acupuncture is safe for people with MS. Also, keep in mind that there are always risks when a procedure involves puncturing the body with needles, as is done with acupuncture. The main risk is infection. Unless sterile techniques are used, acupuncture could transmit hepatitis or HIV.
  • Evening primrose oil (linoleic acid). Linoleic acid is also found in sunflower seeds and safflower oil. There is some evidence that taking an oral supplement of linoleic acid may slightly improve MS symptoms.
  • Diet. It is important for people with MS to maintain a healthy, well-balanced diet to keep them as healthy as possible. Discuss any dietary concerns you may have with your doctor.
  • Marijuana. The use of marijuana to treat any illness remains highly controversial. Some people with MS claim that smoking marijuana helps relieve spasticity and other MS-related symptoms. However, there is little evidence to date that marijuana really works. Research is ongoing to answer this important question. Until more is known, doctors do not recommend the use of marijuana to treat MS, as the drug is associated with serious long-term side effects such as heart attack or memory loss.

How can I tell which therapies are worth taking?

Alternative therapy can be helpful in many cases, but some treatments can be ineffective, costly, and even dangerous. The best way to evaluate your options is to become educated. Ask yourself the following questions:
  • What is the treatment?
  • What does it involve?
  • How does it work?
  • Why does it work?
  • Are there any risks?
  • What are the side effects?
  • Is it effective? (Ask for evidence or proof.)
  • How much does it cost?
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What is a Cannabinoid? (aka CBD)


                                                                  
  
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The Human Endocannabinoid System & Your Health

What is the Endocannabinoid System?

The endocannabinoid (EC) system is a unique biological system which earned its name from the cannabis sativaplant that led to its discovery. The system plays an integral role in your overall physical and psychological health. It is comprised of three components:
  • Endogenous cannabinoids
  • Cannabinoid receptors
  • Metabolic enzymes
Though the EC system may serve different functions in different tissues, the overall goal of the entire endocannabinoid system is to achieve homeostasis, the body’s ability to maintain and regulate a stable internal environment despite ever-changing external conditions.
The to be contacted by a counselor for CBD oil information click:  https://greenroadswellness.com/1236-2/  
Note: Though this product may work for many, it does not work for everybody


  
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Understanding MS, the Actelion way


                                                                  
  
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Understanding MS

“ONE OF THE HARDEST THINGS FOR PEOPLE TO UNDERSTAND IS HOW MS IS COMPLETELY UNIQUE TO EACH INDIVIDUAL. NO TWO PEOPLE ARE THE SAME. AND THERE IS A HUGE SPECTRUM OF SEVERITY. I TELL PEOPLE THAT JUST BECAUSE THEY KNOW ME, DOESN'T MEAN THEY KNOW MS.”



Are you ready to get a glimpse of what it is like to live with MS?




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What is a clinical trial?


                                                                  
  
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Clinical trials can offer hope for many people and may help researchers find better treatments for others in the future.



A clinical trial is a research study in human volunteers that tests new ways to prevent, detect, diagnose or treat diseases. They help determine whether investigational vaccines, medicines, or new uses for existing medicines are safe and effective. Clinical trials are necessary to find potential medicines and vaccines that work to improve people’s health.
Clinical trials are also known as intervention studies, clinical studies or clinical research.

Phases of Clinical Trials


http://www.merck.com/clinical-trials/about-clinical-trials.html

Phase 1: Phase 1 clinical trials test the medicine or vaccine in a small group of 20 to 100 volunteers who are usually healthy, but not always. The trial often takes place in a hospital. The goals are to determine:
  • If the medicine or vaccine is safe
  • If there are any side effects
  • How the medicine is broken down by and discharged from the body
  • How much medicine is needed and how often
  • For a vaccine, researchers see if it causes the desired response from the body’s immune system

Phase 1 trials can take from six months to one year to complete.

Phase 2: Phase 2 clinical trials test the vaccine or medicine in approximately 100 to 500 volunteers. In the case of medicines, volunteers usually have the disease or condition the investigational medicine is designed to treat. In vaccine studies, the volunteers are usually healthy. The goals of this phase are to determine:
  • How well the medicine or vaccine works
  • If the medicine or vaccine is safe
  • If there are any side effects
  • How much of the medicine or vaccine is needed and how often

Phase 2 trials can take from six months to one year or more to complete.

Phase 3: Phase 3 clinical trials can test the medicine or vaccine in 1,000 to 5,000 patient volunteers. For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics or physician offices. Researchers closely monitor patients at regular intervals to:
  • Confirm that the medication or vaccine is effective
  • Identify and monitor side effects
  • Compare the medicine or vaccine to commonly used treatments
Phase 3 trials can take from one to four years to complete, depending on the disease, length of study and the number of volunteers.

Phase 4 or On-going trials: Phase 4 clinical trials are conducted after the medicine or vaccine has been approved by the appropriate government and regulatory agencies and is being marketed. Researchers continue to gather information about the medicine or vaccine and its safety, side effects and effectiveness.
Marketed products also are studied for new indications. Thousands of people usually participate in ongoing trials.

Note: Becoming knowledgeable and informed is a first step when considering participation in a clinical trial. These additional resources for patients and caregivers may help you.

Find clinical trials in the USA by visiting the NIH website: 
https://www.nih.gov/health-information/nih-clinical-research-trials-you

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Monday, July 3, 2017

Mavenclad Reduces MS Relapses by Reseting the Immune System


                                                                  
  
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Data Provide Additional Insight Into the Mode of Action of MAVENCLAD(TM) (Cladribine Tablets) in Patients With Relapsing MS

DARMSTADT, Germany, Jun 26, 2017 (PR Newswire Europe via COMTEX) -- DARMSTADT, Germany, June 26, 2017 /PRNewswire/ --

- Data suggest that MAVENCLAD(TM) (Cladribine Tablets) selectively and discontinuously reduces B and T lymphocytes, with lymphocyte counts returning to normal range before the end of Year 2 - The lymphocyte data presented at EAN Congress are consistent with other clinical safety presentations of MAVENCLAD(TM) (Cladribine Tablets) at the congress.
Merck, a leading science and technology company, today announced the presentation of safety and efficacy data on MAVENCLAD(TM) (Cladribine Tablets) for the treatment of relapsing MS at the 3rd Congress of the European Association of Neurology (EAN), in Amsterdam, the Netherlands. Data from the placebo-controlled CLARITY, CLARITY Extension and ORACLE-MS clinical trials support the benefit: risk profile of Cladribine Tablets that have prompted an application for marketing authorisation in the EU, and the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

About MAVENCLAD(TM) (Cladribine Tablets) -  Cladribine Tablets is a short-course oral therapy that is believed to selectively and periodically target lymphocytes thought to be integral to the pathological process of MS. Cladribine Tablets is currently under clinical investigation and not yet approved for the treatment for any use in the United States, Canada and Europe. In June 2017, the Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion on the use of Cladribine Tablets for highly active relapsing MS, and this recommendation has been passed on to the EC to make the final decision on the Marketing Authorization Application (MAA) later this year.

In these studies, Cladribine Tablets was administered as two annual treatment courses in Years 1 and 2, with a total maximum of 20 days of oral treatment equal to a dose of 3.5 mg/kg body weight, followed by no further active treatment in Years 3 and 4.

"These data presented at EAN Congress 2017 bring the MS treating community closer to understanding the mechanism of action of Cladribine Tablets," said Professor Per Soelberg SArensen, presenting author and Head of MS Research Unit, Danish Multiple Sclerosis Centre. "These data support the emerging theories around the ability of some agents to selectively 'reset' the immune system without the secondary autoimmunity that we sometimes see with treatments for relapsing MS. This would represent a significant advance in the field."

Data from three key studies suggest that Cladribine Tablets selectively and discontinuously reduce both B and T lymphocytes in patients with early and relapsing forms of MS. An early and discontinuous reduction of peripheral blood B cells was seen, with cells numbers reaching a nadir at 13 weeks after treatment, followed by a rapid reconstitution toward baseline. A moderate reduction in T cell counts was also shown, although to a lesser degree than B cells; this reduction was more pronounced in CD4+ than CD8+ lymphocytes.

An exploratory analysis of the CLARITY data suggests that if strict lymphocyte count rules are adhered to before each yearly short course treatment, then the proportion of patients recovering at the end of Year 1 was 89.1% and at the end of Year 2 was 88.3%. Given the clinical effect observed during Years 1 and 2 of dosing in CLARITY, and beyond Years 1 and 2 with CT 3.5 mg/kg in CLARITY EXT, these data demonstrate that the clinical effect observed is achieved without continuous immunosuppression and through selective effects on B and T cell populations.

"Following last week's positive CHMP opinion, this integrated safety data, including 8 years of follow up in some patients, further supports the use of Cladribine Tablets as a treatment option for patients with MS," said Luciano Rossetti, Global Head of R&D for the biopharma business of Merck.

On 23 June, the Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion on the use of Cladribine Tablets for relapsing MS, and this recommendation has been passed on to the European Commission (EC) to make the final decision on the Marketing Authorization Application (MAA) later this year.

Lymphopenia was the most commonly reported adverse event (AE) in patients treated with Cladribine Tablets. The incidence of infections was 48.3% with Cladribine Tablets and 42.5% with placebo, with 99.1% and 99.0% rated mild-to-moderate by investigators.

MAVENCLAD(TM) is the proprietary name submitted to EMA for the investigational medicine Cladribine Tablets.






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