research

When talking about MS research, we tend to focus on drug development because improved therapies, and even the cure for MS, will come from pharmaceuticals. But what do we know about other MS research that doesn’t involve taking a pill or enduring an injection? I’m talking about those…

Researchers at Duke University want to determine if data collected through an iPhone app can ably capture individual experiences in people with multiple sclerosis to improve doctor-patient communication and overall disease understanding. According to a National MS Society report, the researchers want to investigate the benefits combining mobile phone-based data with machine learning (the ability of a smartphone to mimic human behavior) and patient participation. The study is currently enrolling MS patients, 18 or older, live in the United States and be able to read and understand English. Participants must own or have daily access to an iPhone (iOS 9 or greater) to download a free, MS Mosaic app from the Apple Store. The app is not yet available for Android phones. The rationale behind the study is that MS can be an extremely complex condition, with symptoms ranging from numbness, walking difficulty, to vision impairment and fatigue. Each patient's experience is different and can be affected by medication, emotional health, and environmental factors. This complexity can complicate research. Study participants will receive daily, weekly and monthly questionnaires to fill about their symptoms. Daily surveys should take no longer than a minute to complete, and weekly surveys about ten minutes. Initial registration should take about 20 minutes, the NMSS report says. In some of the surveys, participants will be asked to perform specific tasks while holding or using the mobile phone, like walking 25 steps, turning around, then walking back 25 steps – while holding the phone. Other tests include tapping on the phone screen repeatedly to test motor speed, coordination and fatigue, or playing a pattern game to assess short-term memory. These tasks should take about five minutes each. Patients can choose not to answer some of the questions or to participate in certain tasks. All information is collected through the app, and will be sent to a secure data server. Participants can export data to share with a healthcare provider. Each person will be identified by a code, and data will be analyzed in a way that maintains confidentiality. Researchers, however, be able to identify a participant should they need to do so for "research integrity or legal purposes," the report states. Questions regarding this study can be answered by sending an email to [email protected].

The 7th Joint ECTRIMS-ACTRIMS Meeting, the world’s largest annual international conference devoted to basic and clinical research in multiple sclerosis, will run from Oct. 25 to 28 in Paris — the city of Jean-Martin Charcot, the “Father of Neurology,” who provided the first detailed description of multiple sclerosis (MS)…

Non-invasive brain stimulation reduces fatigue in multiple sclerosis patients, concludes a study by researchers at New York University. Fatigue is one the most disabling symptoms of MS, affecting roughly 75 percent of people with the disease. Doctors often prescribe drugs to treat narcolepsy, as well as behavior-based treatments and exercise programs, but their benefits have not been consistent. This led scientists to study a technique of brain stimulation called transcranial direct current stimulation (tDCS), which had shown positive results in earlier neurology studies, including improvements of cognitive symptoms in MS. In tDCS, doctors place electrodes on the scalp via a headset to apply a low-amplitude electrical current at the dorsolateral prefrontal cortex — a brain region believed to play a role in fatigue and cognitive symptoms. The technique has been proven safe and tolerable. The NYU study randomly assigned 27 MS patients to receive either tDCS or placebo. Patients got treatment while playing a cognitive game directed at the brain’s processing speed and working memory. Sessions lasted 20 minutes each and took place five days a week, at patients’ homes. Participants reported their level of fatigue after 20 sessions, using a scale known as the Patient-Reported Outcomes Measurement Information System (PROMIS) that grades fatigue on a score of up to 32. A higher score correlates with more fatigue. The results showed a significant 5.6-point drop with tDCS, compared to a 0.9 point increase in the placebo group. Furthermore, patients may benefit from more sessions, since those who underwent 20 sessions reduced fatigue more than those who did only 10. The study also showed that patients with the most fatigue at baseline saw the biggest improvements. Remarkably, many participants reduced their fatigue to near-normal levels, researchers observed. Further studies are needed to ascertain the precise mechanism behind tDCS. Scientists believe it changes the brain’s excitability, which improves connections and facilitates learning. Meanwhile, the study's authors strongly advise MS patients not to try over-the-counter stimulation technologies outside of a reliable research setting. The research team plans to test tDCS in larger clinical trials for MS-related fatigue, motor and cognitive symptoms. Currently, the Multiple Sclerosis Comprehensive Care Center at NYU Langone Health is the only one in the United States to offer tDCS to MS patients.

Fast Forward, a non-profit subsidiary of the National Multiple Sclerosis Society, will give financial support to TG Therapeutics to advance TGR-1202 (umbralisib) into preclinical testing as a potential oral therapy for progressive forms of multiple sclerosis. The support, whose value was not specified, is part of a Sponsored Research Agreement between Fast Forward and the company. Research work will be led by Lawrence Steinman, MD, a professor of pediatrics, neurology, and neurological sciences at Stanford University. TGR-1202 is an orally administrated inhibitor that blocks a signaling enzyme called PI3K delta. Immune cells such as B-cells have high levels of this enzyme, which is thought to be important for cell proliferation and survival. "We look forward to evaluating umbralisib [TGR-1202]'s effect on our preclinical progressive MS models in hopes to move umbralisib closer to clinical development in MS," Steinman said. The approval of Ocrevus (ocrelizumab), by Genentech, to treat primary progressive and relapsing multiple sclerosis underscored the potential of B-cell-targeted therapies for MS patients. As a result, investigative drugs that also aim to bolster B-cell survival or activity, such as those being developed by TG Therapeutics, are an attractive approach to potentially treating patients. Another potential treatment by the company — an engineered antibody, TG-1101 — targets a specific sequence on the CD20 protein found on immune B-cells. This infusion therapy is now in two Phase 3 clinical studies for relapsing multiple sclerosis, ULTIMATE I and ULTIMATE II. Both are currently enrolling patients at sites in Kentucky, Tennessee, and New York.

A clear association was seen between the substantial pain that multiple sclerosis (MS) patients experience and lifestyle choices that either augment or ease that pain, like smoking habits, exercise, and diet and weight, researchers in Australia report. Common co-morbidities associated with MS, such as depression, anxiety, and fatigue, were also…

A five-year study demonstrated that Sanofi-Genzyme’s Lemtrada (alemtuzumab) provides long-term benefits for relapsing-remitting multiple sclerosis patients, reducing relapse rates and preventing the progression of the disease. Importantly, most patients required only the standard two-phase treatment course. Few needed additional courses because of relapse or new brain lesions. The study,…

Swiss regulatory authorities approved Ocrevus as a treatment for primary progressive and relapsing forms of multiple sclerosis on Sept. 28, making it the first approval of the drug in a European country. Since Switzerland is not part of the European Union, the approval will not affect the drug's regulatory status in other European countries. So far, the Roche/Genentech drug Ocrevus has been approved in North America, South America, the Middle East, Ukraine, and Australia. Like other countries where Ocrevus has been approved, it's the first drug OK'd in Switzerland for primary progressive MS, a form of the disease where disability moves forward relentlessly. And, as in other countries, the treatment option is equally appreciated among patients with relapsing types of MS. Ocrevus — an antibody that targets B-cells with the surface factor CD20 — was studied in two large Phase 3 trials in patients with relapsing MS called OPERA I and OPERA II (NCT01247324 and NCT01412333). Another trial, called ORATORIO (NCT01194570), is focused on people with primary progressive disease. The trials showed that the treatment significantly reduced disease activity and prevented progression in both patient groups. Researchers compared Ocrevus to Rebif (high-dose interferon beta-1a) in relapsing MS and to a placebo in primary progressive MS. Scientists also consider the drug to have a good safety profile. The most common side effects during the trials were mild-to-moderate infusion reactions and upper respiratory tract infections. Since its approval, researchers also have concluded that the treatment is less expensive than interferon. Ocrevus was approved in the U.S. on March 28, 2017. In the months that followed, many patients were concerned about the trial findings of more cancer cases in the treated, compared to control, groups. Since then, an increased risk of cancer with Ocrevus has not been confirmed, and researchers underscore that it is instead the coincidental and unusual circumstance that there were no cancer cases in the control group that created the imbalance. The European Medicines Agency is still processing the marketing application for Ocrevus. Roche reports that the company has filed marketing applications in more than 50 countries worldwide.

The majority of people living with multiple sclerosis who use wheelchairs or scooters for mobility reported falling at least once over a six-month period, according to a new study. While most studies have focused on ambulatory MS patients, this may be the first study to assess the prevalence and circumstances of falls among those who already experience significant mobility issues and require the use of wheelchairs or scooters to get around. In ambulatory MS patients who are able to move around on their own, about 50 percent reported falling during a six-month period. The current study recruited 44 MS patients from May 2014 to July 2015 who required wheelchairs or scooters to move about. These patients were from medical centers across the United States and Asia. They were asked to complete a survey focusing on the prevalence of falls, the frequency of injuries, the circumstances surrounding the falls, and quality-of-life indicators. Thirty-three of the 44 participants (75 percent) reported falling at least once in the previous six months. This number is higher than any of the other studies that assessed the prevalence of falls in MS patients. Many of these people experienced more than one fall within those six months. Of these falls, 87.5 percent occurred inside the home. The top four activities reported by participants that led to these falls included using the toilet, transferring, walking short distances, and reaching for an object. Some of the people said the falls were serious, and 8 percent of participants reported an injury because of their fall. Perhaps for this reason, many reported concerns about falling (76.7 percent). And, more telling, 65.9 percent of these MS patients reported altering their activities because they feared falling. The use of mobility devices may affect the prevalence of falls. Participants were asked if they had fallen using a specific mobility device. Here is how they responded: 66.7% reported falling while using power wheelchairs; 37.5% fell while using manual wheelchairs; 66.7% fell when using scooters; 71.4% reported falling while using a walker; 100% fell while using a cane. Because of the high prevalence of falls while using a mobility device, researchers said, clinicians should provide better education regarding the use and function of these mobility devices. There were no significant correlations between people who experienced falls and quality-of-life indicators in this study. Results from the study highlight the need for interventions specifically targeted for MS patients who use mobility devices such as wheelchairs and scooters. The body of research regarding predictors of falls suggest that some of the risk factors can be modified; therefore, more effort should be made to prevent falls using targeted rehabilitation interventions.

Opioid growth factor (OGF) can serve as a new biomarker to determine diagnosis and progression of multiple sclerosis (MS), say researchers at Pennsylvania State University. Their study, “Serum [Met5]-enkephalin levels are reduced in multiple sclerosis and restored by low-dose naltrexone,” appeared in the journal Experimental Biology and…

Do you ever stop and ponder the value of MS drugs? I’m not talking about if they work and the ways they improve our lives. I’m thinking of the COST of them and what their pricing means to investors. I get several market analysis reports on the pharmaceutical industry,…

Active brain inflammation appears to be one of the causes driving anxiety and depression in patients with relapsing-remitting multiple sclerosis (RRMS), finds an Italian study published in the journal Neurology. RRMS is the most common form of the disease when patients are initially diagnosed. Multiple sclerosis patients…

Researchers at the University of Nottingham and neurologists at Nottingham University Hospitals NHS Trust in England will be working with a team from the Cleveland Clinic in Ohio to better understand the best therapeutic strategy for multiple sclerosis (MS) patients. The $10.6 million international clinical trial was one of five…

The Patient-Centered Outcomes Research Institute (PCORI) has awarded $13.4 million to two scientists at Baltimore’s Johns Hopkins University (JHU) to study how best to treat newly diagnosed patients with relapsing-remitting multiple sclerosis (RRMS). The study will be led by Dr. Ellen Mowry, an associate professor of neurology and epidemiology at…

Researchers have taken the first steps towards the development of a gene therapy for multiple sclerosis — a treatment that boosted anti-inflammatory immune processes and reversed severe paralysis in mouse models of the disease. The University of Florida Health research team said it was optimistic that the therapy can work…

Behavioral therapy focusing on goal attainment might reduce cognitive fatigue in multiple sclerosis patients, finds a study that used brain imaging to examine goal-oriented tasks involving rewards. Since fatigue is one of the most common MS symptoms, affecting up to 90 percent of patients, researchers at the Kessler Foundation in East Hanover, New Jersey, say their findings could open the door to new non-medication approaches to treating MS-related fatigue. Scientists believe that a part of the brain, called the fronto-striatal network, causes fatigue. But studies also show that the network is active during goal attainment tasks, and that such tasks can reduce fatigue in healthy people. Equipped with this knowledge, Kessler researchers recruited 19 MS patients and 14 healthy controls, and exposed them to one of two conditions. In the first, they had the chance to win money while gambling. Researchers called this the outcome condition. The second condition did not include the prospect of a reward, or outcome. The tasks were performed in a brain scanner. Using functional magnetic resonance imaging of the brain — a method that tracks brain activity by monitoring blood flow — researchers could study how different tasks activated the fronto-striatal network. It turned out that the prospect of a reward activated parts of the network in deep brain structures, while parts of the prefrontal cortex were more active during the task without a potential reward. Importantly, the activation seen during the reward condition was linked to significantly lower levels of fatigue, which researchers measured outside the scanner. While researchers used a gambling task to study the process, similar exercises like achieving a good score on a test, might work equally well, researchers said. In fact, goal attainment is already incorporated in many neuropsychological rehabilitation efforts, including in MS.

Two molecules known to regulate cellular signaling contribute to the underlying mechanism of progressive multiple sclerosis, found a recent study conducted by investigators at Oregon Health & Science University and Yale University School of Medicine. These two proteins are related to each other, as they participate in the same cellular signaling process that regulate the immune system's response. Previous studies have blamed them for the worsening of several autoimmune and inflammatory disorders including rheumatoid arthritis, systemic sclerosis and systemic lupus erythematosus. The research team found that patients with progressive MS had higher levels of MIF and D-DT proteins than those with the relapsing-remitting form of the disease. In addition, these proteins inflamed the central nervous system, making patients sicker. An analysis of the genes that encode the proteins revealed that higher levels of MIF were linked to the presence of two genetic variants that are more frequent in patients — particularly males — with progressive disease. Researchers confirmed their findings with animal models of MS-like disease that were genetically engineered to lack MIF and D-DT proteins. Taken together, this finding suggests that a simple genetic test could identify patients carrying the MIF genetic susceptibility — and therefore more likely to develop a severe form of MS. This study was partially funded by the National Institutes of Health, the National Multiple Sclerosis Society, the Rocky Mountain MS Center Tissue Bank and the U.S Department of Veterans Affairs.

Disarm Therapeutics has completed the first round of financing to develop a compound that prevents axonal degeneration in patients with multiple sclerosis (MS) and other neurodegenerative conditions. The treatment approach is based on an earlier discovery at Washington University in St. Louis, showing that the enzyme SARM1…

The life science tech company IQuity has begun taking orders from physicians for an RNA-based blood test that can provide reliable yes or no results for multiple sclerosis in seven days – dramatically faster than previous options, which took months or years. The test, IsolateMS, can be a game-changer in…

“I’m sorry, these files take forever to copy,” the woman at the registration desk says, breaking the silence that had settled between us while she uploaded MRI scans from the CD I gave her moments earlier. “I know it can be a…

People with multiple sclerosis (MS) often face geographic barriers that end up limiting their treatment options. That has led a Case Western Reserve University researcher to test online- and teleconference-based methods of reducing fatigue and improving patients’ quality of life. Matthew Plow, assistant professor at the university’s Frances Payne Bolton…

The U.S. Patent and Trademark Office has issued a patent for human embryonic stem cells derived mesenchymal stem cells, called hES-T-MSC or T-MSC, and for their method of production. This newly patented technology was developed by ImStem Biotechnology in collaboration with the University of Connecticut (UConn) to advance new…

TG Therapeutics is recruiting participants for two Phase 3 clinical trials that will evaluate the safety and effectiveness of TG-1101 (ublituximab) as a treatment for relapsing forms of multiple sclerosis. ULTIMATE 1 (NCT03277261) and ULTIMATE 2 (NCT03277248) will compare TG-1101, a glycoengineered monoclonal antibody, with Genzyme’s Aubagio…

Women with low levels of vitamin D in their blood are more likely to develop multiple sclerosis (MS) later in life, finds a large-scale study on women in Finland. The study, “25-Hydroxyvitamin D deficiency and risk of MS among women in the Finnish Maternity Cohort,” appeared in the journal…

A European Patent Office decision has opened the door to Synthon providing cheaper generic versions of Teva Pharmaceutical’s Copaxone to people with relapsing multiple sclerosis. What looks like the final hurdle to the generics was cleared when the patent office’s Technical Board of Appeal revoked the last of the patents that Teva…

Probiotics may improve the health of people with multiple sclerosis (MS) by reducing disability and improving inflammatory and metabolic parameters, an Iranian study shows. Live microorganisms linked to health benefits, known as probiotics, have long been known to help chronic disease patients. In a previous study of people with major depressive disorder, probiotics treatment for eight weeks improved patients’ depression and metabolic parameters. More recently, authors investigated the impact of probiotics on a group of MS patients, looking not only at mental health and metabolic indicators, but also disability scores. Researchers at Tehran's Shahid Beheshti Hospital recruited 60 MS patients, divided them in half, and assigned 30 to take a probiotic capsule and 30 a placebo once a day for 12 weeks. The probiotic contained the healthy bacteria Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium bifidum and Lactobacillus fermentum. Researchers measured patients’ health parameters and disability scores at baseline and after treatment. The results showed that probiotic intake after 12 weeks improved MS patients' disability scores (assessed by the expanded disability status scale, EDSS) when compared to placebo controls. Although this improvement was statistically significant, it was not clinically significant — which is defined as a change of 1.0 point or more at EDSS levels less than 5.5, or 0.5 point or more at EDSS levels greater than 5.5). Moreover, benefits were also detected in several mental health parameters – Beck Depression Inventory, general health questionnaire-28 (GHQ-28), depression anxiety and stress scale. Consuming probiotic capsules also significantly decreased insulin levels and high-density lipoprotein (HDL) cholesterol in circulation, researchers also found. It also lowered certain markers of inflammation and oxidative stress, such as serum high-sensitivity C-reactive protein (hs-CRP) and malondialdehyde (MDA).

The Patient-Centered Outcomes Research Institute has awarded $38 million in grants for five projects that compare the effectiveness of different multiple sclerosis treatment strategies. A key aim of the research is to improve knowledge about the therapies to help doctors and patients choose the healthcare option that best meets patients’ needs. The…

How many hours do the pharmaceutical companies think we have in our day? I ask because almost all of them have come up with very slick tools to use, particularly mobile apps, to help us improve our daily lives with MS. Not coincidentally, these apps also provide their…

Ocrevus (ocrelizumab) is a less expensive treatment option for relapsing multiple sclerosis (MS) than subcutaneous interferon beta-1a (Rebif) in the long-run, according to a cost-effectiveness analysis published in the Journal of Medical Economics. In addition to lower total costs over a 20-year period, the analysis suggested that Ocrevus…

Specific gut bacteria may drive the progression of multiple sclerosis, according to a study showing that two bacterial species made the disease worse in a mouse model of MS. Researchers at the University of California, San Francisco also pinpointed a species — found in lower numbers in MS patients —…