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Saturday, December 23, 2017

Listening to Dr Aaron Boster and Comprehensive Care by Brain Injury Radio







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Boster's Corner video: Why I don’t use narcotics in my Multiple Sclerosis practice

Published on Dec 23, 2017


Dr. B has never prescribed narcotics. In this video he explained his personal opinions on why he chooses not to use narcotics in his multiple sclerosis practice. There are many different types of chronic neuropathic pain that can occur in the setting of multiple sclerosis. We believe that using narcotics to treat these pains is not the right decision. Dr. B provides two reasons: One is the national opioid crisis. The other reason relates to the biologic mechanisms of narcotics and some of the long term problems that can arise when using narcotics to treat chronic neuropathic pain.




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Wednesday, December 20, 2017

Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication - Retained in Body; New Class Warnings

December 19, 2017

Audience: Radiology, Health Care Professional, Patient
ISSUE: FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and FDA has concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.
However, after additional review and consultation with the Medical Imaging Drugs Advisory Committee, FDA is requiring several actions to alert health care professionals and patients about gadolinium retention after an MRI using a GBCA, and actions that can help minimize problems. These include requiring a new patient Medication Guide, providing educational information that every patient will be asked to read before receiving a GBCA. FDA is also requiring manufacturers of GBCAs to conduct human and animal studies to further assess the safety of these contrast agents. 
To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis (NSF) that occurs in a small subgroup of patients with pre-existing kidney failure. FDA received reports of adverse events involving multiple organ systems in patients with normal kidney function. A causal association between these adverse events and gadolinium retention could not be established.
GBCAs are used with medical imaging devices called MRI scanners to examine the body for problems such as cancer, infections, or bleeding. GBCAs contain gadolinium, a heavy metal. These contrast agents are injected into a vein to improve visualization of internal organs, blood vessels, and tissues during an MRI, which helps health care professionals diagnose medical conditions. After being administered, GBCAs are mostly eliminated from the body through the kidneys. However, trace amounts of gadolinium may stay in the body long-term. Many GBCAs have been on the market for more than a decade.

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Tuesday, December 19, 2017

Novartis multiple sclerosis therapy Fingolimod granted FDA Breakthrough Therapy designation for pediatric MS

Breakthrough Therapy designation can expedite the development and review of therapies for serious conditions(1)

- In a pivotal Phase III study, oral fingolimod significantly reduced relapses by 82% in a pediatric patient population vs. interferon beta-1a intramuscular injection(2)

- Currently, no disease-modifying therapies are approved for pediatric patients with MS, who often have more frequent relapses than adults with early MS(3)

NEWS PROVIDED BY
Novartis 
Dec 18, 2017, 09:00 ET

EAST HANOVER, N.J., Dec. 18, 2017 /PRNewswire/ -- Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for fingolimod for the treatment of children and adolescents 10 years of age or older with relapsing multiple sclerosis (MS). Fingolimod, also known as Gilenya® in the US, is approved to treat relapsing forms of MS in adults. Gilenya is not currently approved for children and adolescents with relapsing MS.

The Breakthrough Therapy designation is based on data from the Phase III PARADIGMS study, which evaluated the safety and efficacy of fingolimod vs. interferon beta-1a in children and adolescents (ages 10 or older) with relapsing MS4. PARADIGMS, the first completed randomized, controlled clinical trial specifically designed for pediatric relapsing MS, found that treatment with fingolimod resulted in an 82% reduction in the rate of relapses (annualized relapse rate) in this patient population over a period of up to two years, compared to interferon beta-1a intramuscular injection (p <0.001)2. The safety profile of fingolimod in this study was overall consistent with that seen in previous clinical trials in adults5.

"Despite the fact that children experience approximately two to three times as many relapses as a typical adult onset MS patient, there are currently no disease-modifying therapies approved for the pediatric population," said Dr. Tanuja Chitnis, Director of the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston, US, and Scientist, Ann Romney Center, Brigham and Women's Hospital, Boston, US. "Children with MS differ from adults in important ways and additional treatment options for pediatric patients are needed," added Dr. Chitnis, who also served as principal investigator for the PARADIGMS study.

The FDA grants Breakthrough Therapy designation for therapies that are intended to treat a serious condition and that have preliminary clinical evidence indicating that the treatment may demonstrate substantial improvement over available therapy on one or more clinically significant endpoints. This designation is a process designed to expedite the development and review of such therapies1.


"We're proud of this regulatory milestone, which represents part of our commitment to advance treatment options for young people with MS," said Fabrice Chouraqui, President of Novartis Pharmaceuticals Corporation. "Novartis is looking forward to working with the FDA to bring a therapy with a long track record in adults with relapsing MS to this younger patient population as soon as possible."

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Evaluating Near-Fallers and Fallers with MS

Mult Scler Relat Disord; ePub 2017 Nov 21; Fritz, et al

December 19, 2017


Near-fallers and fallers with multiple sclerosis (MS) reported similar circumstances surrounding fall events and demonstrated similar performance on standard timed walking tests, a recent study found. To that end, clinicians monitoring individuals with MS should consider evaluation of the circumstances surrounding falls in combination with quantitative walking measures to improve determination of fall risk and appropriate rehabilitation interventions. In a single visit, 135 MS participants completed the Hopkins Falls Grading Scale, a custom questionnaire investigating circumstances surrounding falls and near-falls, and performed the Timed Up and Go and Timed 25-Foot Walk tests.

Researchers found:

30% of individuals reported falls, while 44% reported near-falls over a 1-year period.
Non-fallers completed the walking tests more quickly than near-fallers and fallers; near-fallers and fallers demonstrated similar motor profiles.

Individuals were more likely to sustain a fall rather than a near-fall under the following circumstances: transferring outside the home and tripping over an obstacle.
Performing 1-second slower on the walking tests increased the odds of a history of a fall by 6–20%.

Citation:
Fritz NE, Eloyan A, Baynes M, Newsome SD, Calabresi PA, Zachowski KM. Distinguishing among multiple sclerosis fallers, near-fallers and non-fallers. [Published online ahead of print November 21, 2017]. Mult Scler Relat Disord. doi:10.1016/j.msard.2017.11.019.

Source



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Physical, Cognitive Functions in Elderly with MS

J Geriatr Phys Ther; ePub 2017 Dec 1; Bollaert, Motl
December 19, 2017

A recent study points to evidence of reduced function in older adults with multiple sclerosis (MS), and this might be partially managed by behavioral interventions that target physical activity and sedentary behavior for the promotion of healthy aging in this population. Participants initially underwent the cognitive assessments, followed by the physical function assessments. They were then instructed to wear an accelerometer and document wear time in a log book for a 7-day period after the testing session. Researchers found:

Older adults with MS (n=40) performed worse on all measures of physical function, and 1 measure of cognitive function (ie, information-processing speed), compared with healthy controls (n=40).
Older adults with MS engaged in less moderate-to-vigorous physical activity, more sedentary behavior, and longer duration of long sedentary bouts than healthy controls.

Levels and patterns of physical activity were significantly associated with a majority of physical function variables but not cognitive function variables in both older adults with MS and healthy controls but to a greater extent in older adults with MS.

Citation:
Bollaert RA, Motl RW. Physical and cognitive functions, physical activity, and sedentary behavior in older adults with multiple sclerosis. [Published online ahead of print December 1, 2017]. J Geriatr Phys Ther. doi:10.1519/JPT.0000000000000163.

Article source

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Healthy Diet, Lifestyle Linked with Less Disability

Neurology; ePub 2017 Dec 6; Fitzgerald, et al
December 19, 2017

A healthy diet and a composite healthy lifestyle are associated with lesser disability and symptom burden in multiple sclerosis (MS), according to a recent study. In 2015, participants in the North American Research Committee on MS (NARCOMS) Registry completed a dietary screener questionnaire that estimates intake of fruits, vegetables and legumes, whole grains, added sugars, and red/processed meats. Researchers constructed an overall diet quality score for each individual based on these food groups; higher scores denoted a healthier diet. They assessed whether a composite healthy lifestyle measure, a healthier diet, healthy weight (body mass index <25), routine physical activity, and abstinence from smoking was associated with symptom severity. They found:

Of the 7,639 (68%) responders, 6,989 reported physician-diagnosed MS and provided dietary information.

Participants with diet quality scores in the highest quintile had lower levels of disability and lower depression scores.

Individuals reporting a composite healthy lifestyle had lower odds of reporting severe fatigue, depression, pain, or cognitive impairment.

Citation:
Fitzgerald KC, Tyry T, Salter A, et al. Diet quality is associated with disability and symptom severity in multiple sclera. [Published online ahead of print December 6, 2017]. Neurology. doi:10.1212/WNL.0000000000004768.

Source



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Black Hole Assessment Method in Multiple Sclerosis

Mult Scler Relat Disord; ePub 2017 Dec 2; Adusumilli, et al
December 19, 2017


A method designed to classify and estimate the severity of T1-weighted hypointensities (persistent black and gray holes) within multiple sclerosis (MS) can add information to conventional imaging, a recent study found. 38 MS patients contributed images to the study. Intensities of lesions on T1-weighted scans were assessed relative to cerebrospinal fluid intensity using commercial software. Magnetization transfer imaging, diffusion tensor imaging, and clinical testing were performed to assess associations with T1w intensity-based measures. Researchers found:
  • Intensity-based assessments of T1w hypointensities were reproducible and achieved >90% concordance with expert rater determinations of “black” and “gray” holes.
  • Intensity ratio values correlated with magnetization transfer ratios (R=0.473) and diffusion tensor imaging metrics (R values ranging from 0.283 to −0.531) that have been associated with demyelination and axon loss.
  • Intensity ratio values incorporated into T1w hypointensity volumes correlated with clinical measures of cognition.
Citation:
Adusumilli G, Trinkaus K, Sun P, et al. Intensity ratio to improve black hole assessment in multiple sclerosis. [Published online ahead of print December 2, 2017]. Mult Scler Relat Disord. doi:10.1016/j.msard.2017.11.020.
Source



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Age Is Essential Modifier of Drug Efficacy in MS

Front Neuro; ePub 2017 Nov 10; Weideman, et al
December 19, 2017

Progressive multiple sclerosis (MS) is simply a later stage of the MS disease process and age is an essential modifier of a drug efficacy, according to a recent meta-analysis. Furthermore, higher efficacy treatments exert their benefit over lower efficacy treatments only during early stages of MS, and, after age 53, the model suggests that there is no predicted benefit to receiving immunomodulatory disease-modifying therapies (DMTs) for the average MS patient. Researchers performed a literature search with pre-defined criteria and extracted relevant features from 38 clinical trials that assessed efficacy of DMTs on disability progression. They found:

>28,000 MS subjects participating in trials of 13 categories of immunomodulatory drugs were included in the meta-analysis.
The efficacy of immunomodulatory DMTs on MS disability strongly decreased with advancing age.
Inclusion of baseline Expanded Disability Status Scale did not significantly improve the model.
The regression predicts 0 efficacy beyond approximately age 53 years.
The comparative efficacy rank derived from the regression residuals differentiates high- and low-efficacy drugs.
High-efficacy drugs outperform low-efficacy drugs in inhibiting MS disability only for patients aged <40.5 years.

Citation:
Weideman AM, Tapia-Maltos MA, Johnson K, Greenwood M, Bielekova B. Meta-analysis of the age-dependent efficacy of multiple sclerosis treatments. [Published online ahead of print November 10, 2017]. Front Neuro. doi:10.3389/fneur.2017.00577.

Source



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Monday, December 18, 2017

University of Huddersfield Team Develops Blood Test for Diagnosing MS

December 18, 2017

University of Huddersfield researchers have developed a blood test for diagnosing multiple sclerosis that avoids the invasive, painful process of collecting fluid from the brain and spine.

The team at the British discussed the test in an article titled “Sphingosine and dihydrosphingosine as biomarkers for multiple sclerosis identified by metabolomic profiling using coupled UPLC-MS.” It appeared in the journal Analytical Methods.
Medical technicians check the blood sample for two biomarkers of MS — sphingosine and dihydrosphingosine. Scientists have discovered that levels of the compounds are significantly lower in MS patients’ blood.
In addition to offering a new diagnostic tool, the discovery may help scientists learn more about the compounds’ role in the disease, potentially leading to therapies.
“Sphingosine and dihydrosphingosine have been previously found to be at lower concentrations in the brain tissue of patients with multiple sclerosis,” the researchers wrote said in a news release. “The detection of these sphingolipids in blood plasma allows the non-invasive monitoring of these and related compounds.”

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Cell Recycling Process Helps Trigger Immune Attack on Protective Nerve Cell Protein Myelin


December 18, 2017

A cell recycling process helps trigger an immune response against myelin, the protein that protects nerve cells, a multiple sclerosis study indicates.
When University of Zurich researchers eliminated the process, mice developed much milder forms of an MS-like disease. Loss of myelin is the hallmark of MS.
Cell Recycling Process Helps Trigger Immune Attack on Protective Nerve Cell Protein Myelin

In addition to providing key insights into the events leading to MS, the study suggested that there may be other ways to treat the disease than targeting immune cells. MS is an autoimmune disease, or one in which the immune system attacks healthy tissue instead of invaders.
Before the University of Zurich study, scientists knew little about the signals that tell immune T-cells to attack myelin in the brain. The Swiss researchers discovered that a protein that is active in cell material recycling is involved in the signaling.
Cells digest old or unwanted components so they can reuse their building blocks. The recycling process, known as autophagy, is crucial to cells’ health.

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