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Saturday, April 10, 2021
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
April 2, 2021 - by Brian Park, PharmD
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.
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.
April 8, 2021
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.
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.
Friday, April 9, 2021
March 26, 2021
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.
Courtesy of Cathy Chester
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.
The lack of minority participation in MS clinical trials can probably be blamed on a variety of factors.
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
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.
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.