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Friday, September 15, 2017
Thursday, September 14, 2017
Nortis Inc. was awarded a $688,000 grant from the National Institutes of Health. The money will fund the third year of a Small Business Innovation Research fast-track grant from the National Institute of Neurological Disorders and Stroke.
Kevin Banks, PhD, Nortis’ vice president of sales and marketing, told MD Magazine that the technology dovetails nicely with efforts by drug developers to reduce animal testing and lower the rate of clinical trial failures. Banks noted that about 4 of every 10 Phase III studies are failures, a ratio that translates to expensive losses for drug companies.
“This is primarily due to efficacy and safety failures of the drugs, which have been primarily tested to that point using animal models and not human models,” Banks said. “The vision of using human 3D tissue models is to reduce clinical trial failure rates by using more relevant human models early in the drug development process.”
Drug delivery to the brain has long been a challenge for pharmaceutical companies. The blood-brain barrier, which is composed of endothelial tissue, protects the brain from foreign substances and helps maintain a constant environment, but the barrier also can stop drug molecules from getting into the brain.
Thus, companies developing drugs that require entry into the brain to trigger the desired pharmacological response have a major interest in efficiently and reliably figuring out how their therapies hold up against the barrier.
A randomized trial of clitoral vacuum suction versus vibratory stimulation in neurogenic female orgasmic dysfunction.
'Timed up and go' and brain atrophy: a preliminary MRI study to assess functional mobility performance in multiple sclerosis.
A SIMPLE blood test for vitamin D could soon predict a woman's risk of developing multiple sclerosis.
Wednesday, September 13, 2017
September 5, 2017
Depression and fatigue in multiple sclerosis (MS) share several features and have a similar longitudinal course, according to a recent study. However, using cut-off scores to define depression and fatigue, this study also found that non-depressed subjects with high fatigue may be at a greater risk for developing depression. MS subjects who completed a battery of patient reported outcome (PRO) measures including the CES-D and MFIS (n=435) were included in the analysis. Researchers found:
At baseline, 15% of subjects were classified as high on both depression and fatigue scales, 16% were classified as high on the fatigue scale only, and 9% were classified as high on the depression scale only.
There was a high correlation between CES-D and MFIS total scores (r=0.62).
High correlations were also observed between the somatic and retarded activity subscales of the CES-D and each of the MFIS subscales (r ≥0.60).
Subjects with high fatigue scores but low depression scores at baseline were more likely than subjects with low baseline fatigue and depression scores to develop high depression scores at follow-up.
Greeke EE, Chua AS, Healy BC, Rintelli DJ, Chitnis T, Glanz BI. Depression and fatigue in patients with multiple sclerosis. [Published online ahead of print July 31, 2017]. J Neurol Sci. doi:10.1016/j.jns.2017.07.047.
September 5, 2017
The streamlined version of the Expanded Disability Status Scale (sEDSS) for multiple sclerosis (MS) had strong agreement and correlation with the existing EDSS and can provide a useful measure of disability in clinical practice, a recent study found. The EDSS was modified by eliminating maneuvers with no impact on function, consolidating redundancies, and simplifying scoring. This sEDSS was refined and preliminarily validated using a pilot cohort of 102 patients. Subsequently, the sEDSS was retrospectively validated using 968 patients from the CombiRx trial. Researchers evaluated correlation and agreement between each functional system as well as the overall sEDSS and EDSS. They concluded:
The sEDSS correlated strongly with the EDSS, both overall (Spearman’s rho = 0.93) and for each functional system (Spearman’s rho 0.65–0.97).
Correlation was slightly lower for functional systems where scoring was modified for consolidation and simplification.
Urinary urgency with incontinence is associated with recurrent falls in people with relapsing-remitting multiple sclerosis (RRMS) with mild-to-moderate disability, according to a recent study. 51 people aged 18 to 50 years with RRMS and mild-to-moderate disability (Expanded Disability Status Scale score ≤6.0) completed a self-report questionnaire regarding urinary incontinence, urgency, and frequency at baseline and then prospectively recorded their falls daily for 3 months using fall calendars. Participants were classified as recurrent fallers (≥2 falls) or non-recurrent fallers (<2 falls) for 1 regression model and then as fallers (≥1 falls) or non-fallers (no falls) for another regression model. Associations between baseline bladder dysfunction and faller status were assessed using logistic regression adjusted for the potential confounders of age, sex, and disability. Researchers found:
15 participants were recurrent fallers, 36 were non-recurrent fallers, 32 were fallers, and 19 were non-fallers.
After adjusting for age, sex, and disability, there was a significant association between urinary urgency with incontinence and recurrent falls in the 3 months after baseline.
By Farren Briggs PhD, ScM
Earlier this week I was moderating a group discussion among first year medical students on a hypothetical medical case where a physician prescribed his diabetic patient to lose fifty pounds and exercise regularly in order to manage their chronic condition. The students initially thought nothing of this statement, but as we revisited the prescription, they realized the prescription was nonspecific without an actionable plan to encourage adherence and compliance of the diabetic patient to the treatment.
The physician did not give any practical advice on nutrition, healthier food substitutes, best practices for weight loss, or where to begin with exercise – thus, the hypothetical patient would have been left uninformed and unfortunately be stuck with the same old habits.
The students and I spoke about various approaches to improving the prescription, for example motivational interviewing by the physician as a means of identifying the patient’s values and desires, and using that information to facilitate and encourage personal behavior change. I am the first to admit I have always been biased to the positive possibilities of exercise on physical and mental health, but for several years I saw exercise as a luxury, competing with the limited time I had to spend on more important things. Fortunately, I had an academic coach use motivational interviewing to help me realize exercising was a cornerstone of my daily life, and by exercising, I was more productive and effective when I applied myself to other activities. This month there were several publications, not on motivational interviewing, but on physical activity – suggesting exercise improves various outcomes in MS.
Continue to read this article from The Accelerated Cure Project
Tuesday, September 12, 2017
SILVER SPRING, Md. -- An FDA advisory committee voted 13-1, with one abstention, to recommend a new warning for gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging on Friday.
Specifically, the FDA's Medical Imaging Drugs Advisory Committee recommended that prescribing information should include "a warning for retention for all GBCAs with greater retention of all or some of the linear GBCAs compared to the macrocyclics in certain organs including the brain," and that "risk minimization steps" be taken for certain patient populations.
The FDA made a minor distinction between macrocyclic and linear GBCAs, noting the higher stability of the macrocyclics may cause them to "wash out" of the body; but the agency stressed that both agents leave behind deposits of gadolinium.
Agency leadership asked the committee for advice on how to weigh recent findings of gadolinium retention in the brain and other organs, and how to minimize potential risks moving forward. Virtually all committee members agreed that the evidence of retention in patients, to date, doesn't indicate a definitive causal relationship with an array of symptoms reported in the FDA's database and medical literature, beyond previously identified concerns for kidney patients (current labeling already includes a boxed warning and contraindications for this population).
In 2007, researchers uncovered a link between GBCAs and nephrogenic systemic fibrosis (NSF) -- a debilitating condition, that impacts the skin, muscles and internal organs and is sometimes fatal -- in kidney patients, however more recent evidence suggests patients without impaired renal function also show deposits of gadolinium in their central nervous system and throughout the body. As recently as June, researchers reported that gadolinium deposits were found in patients with normal brains -- previously intracranial abnormalities were seen as responsible for the agents clinging to neural tissues.
La comunidad médica puertorriqueña continúa brillando, esta vez en el estudio de la Esclerosis Múltiple (EM) a nivel mundial, ya que pronto los pacientes podrían ser parte de un estudio Fase 3 que daría inicio a la nueva era de terapias dirigidas a la regeneración del sistema nervioso central y la neuroprotección contra la enfermedad, anunció en exclusiva a la Revista Puertorriqueña de Medicina y Salud Pública (MSP) el doctor Ángel Chinea, director del San Juan Multiple Sclerosis (SMS).
Structural changes of the eye retina are a common feature among multiple sclerosis (MS) patients with a clinical history of optic neuritis, a Danish study finds.
Patiently Awakened - A Column by Teresa Wright-Johnson
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