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Saturday, April 10, 2021

Video: CHAIR PILATES for MS

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Video with MS Neurologist, Chris LaGanke, MD - A Compass to MS Care Reaching Rural America - MS Symptom Management and so much more

 Dr. Chris LaGanke, MD, an MS Neurologist from Cullman, Alabama provides discussions on: 

   

 This educational Program was supported by: EMD Serono and Genentech


Tongue-Delivered Neuromodulation Therapy Gets FDA Clearance for MS-Related Gait Deficit

 April 2, 2021 - by Brian Park, PharmD

The PoNS device delivers mild neuromuscular electrical stimulation through a mouthpiece to the dorsal surface of the patient’s tongue.

The Food and Drug Administration (FDA) has authorized marketing of the Portable Neuromodulation Stimulator (PoNS; Helius Medical Technologies) device for use as a short term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (MS).

PoNS is a portable, noninvasive, prescription-only device intended to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and older. The device delivers mild neuromuscular electrical stimulation through a mouthpiece to the dorsal surface of the patient’s tongue, which is then transmitted to the brain through natural pathways. A clinician can view and track a patient’s progress and execution of therapy by connecting the controller unit of the device to a computer.

The FDA authorization was based on safety and efficacy data from 2 clinical studies and a retrospective analysis of real-world data. Findings from a double-blind controlled 14-week study involving 20 MS patients showed that treatment with the PoNS device was associated with a statistically significant and clinically meaningful improvement in the Dynamic Gait Index (DGI) score (an index of 8 tasks used to assess gait, balance, and fall risk), compared with the control group.

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In the second study, 14 MS patients were randomly assigned to receive the PoNS device or a sham control device in addition to cognitive and physical rehab. Results showed that treatment with the PoNS device led to a statistically significant improvement in sensory organization tasks (SOT) score at 14 weeks compared with baseline; no significant results were observed for DGI scores.

As for safety, no serious adverse events were reported in the studies. Patients should not use the PoNS device if they have penetrating brain injuries, neurodegenerative diseases, oral health problems, chronic infectious diseases, unmanaged hypertension or diabetes, pacemakers, a history of seizures, or an active or suspected malignant tumor. The device should also not be used in areas of recent bleeding or open wounds, in areas that lack normal sensation, or in patients with a sensitivity to nickel, gold or copper. The precautions for use of the PoNS device are similar to those for transcutaneous electrical nerve stimulation.

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Risk Factors for Severe COVID-19 in Patients with Multiple Sclerosis

 April 8, 2021

Amit Akirov, MD

Using data from the COVID-19 Infections in MS registry, researchers identified patients with MS and a laboratory-positive SARS-CoV-2 infection or highly suspected COVID-19.

Increased disability, older age, being of Black race, cardiovascular disease, and recent treatment with corticosteroids are risk factors for worse outcomes associated with SARS-CoV-2 infection in patients with multiple sclerosis (MS), according to study results published in JAMA Neurology.

As MS involves the immune system and treatment for these patients may have a significant impact on the immune response, data on clinical outcomes and risk factors associated with outcomes in patients with MS and concomitant SARS-CoV-2 are critical.

The objective of the current study was to assess the clinical outcomes and to identify risk factors associated with SARS-CoV-2 infection in a North American registry of patients with MS.

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Using data from the COVID-19 Infections in MS registry, study researchers identified patients with MS and a laboratory-positive SARS-CoV-2 infection or highly suspected COVID-19 between April 1, 2020, and December 12, 2020.

Clinicians reported the course of COVID-19 and the responses were used to determine the severity of COVID-19: not hospitalized, hospitalization only, intensive care unit (ICU) admission and/or required ventilator support, and death.

The study sample included 1626 patients (74% women; mean age, 47.7 years), including 1345 patients with laboratory-positive SARS-CoV-2 infection and 281 patients with suspected COVID-19. Most participants had relapsing-remitting MS (1255 patients, 80.4%).

During the study period, the overall mortality rate was 3.3% (54 patients), including 43 patients (79.6%) who were hospitalized, 29 patients (53.7%) admitted to the ICU, and 25 patients (46.3%) who required ventilator support.

Mortality increased with age, with highest mortality rate among patients aged 75 years and older (22.6%), while no deaths occurred in those younger than 35 years of age. There was a 76.5% increased risk of death for every 10-year age increase.

Mortality was also significantly higher for Black patients compared with White patients with MS (4.2% vs 3.5%, respectively). After adjusting for covariates, Black patients with MS had a 47% increased odds of hospitalization alone, more than a 2-fold increased risk of ICU admission and/or ventilation, but no increased mortality risk.

Ambulatory disability was associated with increased odds of all clinical severity levels, compared with those not hospitalized. Requiring assistance to walk was associated with at least a 2-fold risk of all clinical severity levels. Being nonambulatory was associated with 2.8-fold increased odds of hospitalization alone, a 3.5-fold increase for ICU admission and/or ventilation, and a 25-fold increased odds of death, compared with fully ambulatory patients.

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Friday, April 9, 2021

Elevated Serum GFAP Predicts MS-Associated Diffuse White Matter Damage

 March 26, 2021

In this study, patients with MS with relapsing remitting or secondary progressive disease underwent diffusion tension imaging and MRI, as well as blood sampling for GFAP determination by single molecule array.

Increased serum glial fibrillary acidic protein (GFAP) levels are associated with measurable microdamage in the normal appearing white matter (NAWM) of patients with multiple sclerosis (MS), suggesting that GFAP could be used as a biomarker for pathology-related astrocytopathy in MS, according to study results published in Multiple Sclerosis and Related Disorders.

In this study, 62 patients with MS (median age, 49.2 years) with relapsing remitting (n=39) or secondary progressive (n=23) disease underwent diffusion tension imaging (DTI) and magnetic resonance imaging (MRI), as well as blood sampling for GFAP determination by single molecule array. A total of 10 healthy controls were also recruited for this study.

Study researchers determined mean fractional anisotropy (FA) as well as mean (MD), axial (AD), and radial (RD) diffusivities within the entire NAWM, in addition to 6 segmented regions of NAWM. They used Spearman correlation analysis to evaluate the relationship between DTI parameters and GFAP levels.

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An Interview with an MS Advocate On Raising Awareness of Living With a Chronic Illness

 

            Courtesy of Cathy Chester

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Cathy Chester first began her advocacy after being diagnosed with multiple sclerosis herself

The process of being diagnosed with a chronic condition like multiple sclerosis can often be a scary experience for both you and your family. That’s why advocate Cathy Chester, who was first diagnosed with the illness in 1986, hopes to provide more awareness and education around the condition.

MS is a chronic illness involving the central nervous system, affecting the brain, spinal cord and optic nerves. Chester emphasized that people can experience a broad range of symptoms — including milder ones like blurred vision and numbness or more severe ones like paralysis and mobility problems.

“My mission is to help the MS community — to educate and to inspire and to empower them with the information they need,” she said.

Check out more of our conversation with Cathy simply by clicking here and being re-directed to the site of Katie Couric, who interviewed Cathy.

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Why Is Minority Participation So Low in MS Drug Trials?

 The lack of minority participation in MS clinical trials can probably be blamed on a variety of factors.

“When trials are created, sometimes there are very strict criteria around, for instance, control of diabetes or hypertension,” explains Mitzi Joi Williams, MD, a neurologist and MS specialist with Joi Life Wellness Group, a private practice in Atlanta. “And that may automatically exclude populations that have higher rates of these other medical problems.”

Other potential barriers to minority enrollment, Dr. Williams says, include the limited number of MS centers that recruit for clinical trials, and reluctance on the part of some groups to participate in trials.

In particular, low enrollment of Black Americans in clinical trials is unfortunate because, by some estimates, this group has the highest risk of MS among racial and ethnic groups in the United States. According to research, including a study published in November 2016 in Multiple Sclerosis Journal, Black and Hispanic Americans with MS tend to experience greater disability than their white counterparts at the same point in the course of their disease.


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So it’s no small thing that a new clinical trial of Ocrevus, called CHIMES (Characterization of Ocrelizumab in Minorities With Multiple Sclerosis), is the first to focus on how an MS treatment affects minority groups — in this case, “self-identified African American and Hispanic or Latin American participants with a diagnosis of relapsing multiple sclerosis,” according to the study description posted on ClinicalTrials.gov.

Here’s what you should know about what researchers aim to learn from this study, and how these findings could change how MS is studied and treated.

READ more, including information on Racial Disparities by Clicking HERE


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New MS Treatment Study Focuses on Black and Hispanic Americans

 The first study of its kind, CHIMES will look at how the drug Ocrevus works in minority groups that are underrepresented in most clinical trials.

CHIMES will try to determine what accounts for faster MS progression among Black and Hispanic

 Americans.iStock



For decades, certain minority groups — including Black and Hispanic Americans — have been underrepresented in clinical trials examining new drugs. This has been especially true in trials of treatments for multiple sclerosis (MS).

One common MS treatment, Ocrevus (ocrelizumab), has had low numbers of minority participants in its clinical trials so far. In studies that compared Ocrevus with another treatment, Rebif (interferon beta-1a), 91 percent of participants were white, 4 percent were Black or African American, and 5 percent belonged to other racial or ethnic groups.

And in a study that compared Ocrevus with a placebo (inactive treatment), 94 percent of participants were white, 2 percent were Black or African American, and 4 percent belonged to other groups.

In each of these studies, minority enrollment was so low that the researchers couldn’t determine any significant differences or similarities between racial or ethnic groups. In fact, the published studies didn’t even show results by race or ethnicity, as noted in an editorial published in January 2019 in the journal CNS Spectrums.

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Minorities With MS Voice Interest in Clinical Trials, But Concerns Evident

 MARCH 16, 2021 

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Regardless of race or ethnicity, people with multiple sclerosis (MS) agree that clinical studies are important and show a willingness and interest in being participants, a primarily U.S. survey found.

Those belonging to minority groups, however, are often deterred from taking part in MS studies for reasons that range from legal and healthcare coverage concerns to mistrust in trial investigators.

Based on these findings, researchers wishing to conduct studies in wide variety of patients are advised to take the time to assure patients that their rights and well-being will always be a priority, and explain the specific measures in place to guarantee those priorities.

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“Researchers can also make their study more attractive to minority groups by highlighting how their study will benefit specific communities. For example, studies of MS treatments could state as an explicit goal the comparison of outcomes in different racial or ethnic groups,” the investigators wrote.

These findings were reported in the study, “Perceptions and Preferences Regarding Multiple Sclerosis Research Among Racial and Ethnic Groups,” published in the International Journal of MS Care.

While MS was once thought to affect mostly whites in the U.S., recent studies found that African-Americans have a higher risk of developing the disorder, and that Hispanic Americans have a more severe disease course.

“Socioeconomic factors, lack of access to specialists, lack of education about MS treatments, and delays in diagnosis with more severe prognoses may contribute to disparities in health outcomes in the African American and Hispanic communities,” the researchers wrote.

Individuals from minority groups tend to be underrepresented in MS trials. This tendency, evident in both public- and industry-funded studies, can have negative consequences, including an unequal distribution of benefits from study participation across populations, further increasing healthcare disparities among minority groups.

Members of the MS Minority Research Engagement Partnership Network (MREPN) — a group of clinicians, researchers, and patient advocates working to identify and address barriers hindering minority participation in MS trials — suggested this trial inequity may be due in part to differences in perceptions and preferences.

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