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Clinical Trials and Neurology

Tapan Mehta, Hui-Ju Young, Byron Lai, Fuchenchu Wang, Yumi Kim, Mohan Thirumalai, Tracy Tracy, Robert W Motl, James H Rimmer
Background: Recent clinical guidelines for adults with neurological disabilities suggest the need to assess measures of static and dynamic balance using the Berg Balance Scale (BBS) and Dynamic Gait Index (DGI) as core outcome measures. Given that the BBS measures both static and dynamic balance, it was unclear as to whether either of these instruments was superior in terms of its convergent and concurrent validity, and whether there was value in complementing the BBS with the DGI. Objective : The objective was to evaluate the concurrent and convergent validity of the BBS and DGI by comparing the performance of these two functional balance tests in people with multiple sclerosis (MS)...
February 15, 2019: Healthcare (Basel, Switzerland)
Farnaz Ebrahimi, Mohammad Hosein Farzaei, Roodabeh Bahramsoltani, Mojtaba Heydari, Kiana Naderinia, Roja Rahimi
Neuropathy is defined as the damage to the peripheral or central nervous system accompanied by pain, numbness, or muscle weakness, which can be due to congenital diseases or environmental factors such as diabetes, trauma, or viral infections. As current treatments are not sufficiently able to control the disease, studies focusing on the identification and discovery of new therapeutic agents are necessary. Natural products have been used for a long time for the management of different neurological problems including neuropathies...
February 15, 2019: Reviews in the Neurosciences
Kenichiro Sato, Tatsushi Toda, Atsushi Iwata
OBJECTIVE: The fragility index (FI), a minimum number of events in 1 arm of a clinical trial required to revert the statistically significant result to nonsignificant, has recently been developed as an easy-to-understand novel metric to evaluate the robustness of randomized controlled trials (RCTs). Here, we evaluated the FI of RCTs in the field of neurology, particularly in studies of ischemic stroke. METHODS: Previous literature published between June 1, 2012 and May 31, 2018 were reviewed from the MEDLINE database by the authors...
February 12, 2019: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
Hai Lu, Menghan Li, Bo Zhang, Xuesong Ren, Lina Meng, Weijing Bai, Li Wang, Zhenzhen Wang, Shaojie Ding, Yuanyuan Gan, Zhilong Zhang, Peifang Li, Linpeng Wang, Zhihong Meng, Hong Zhao, Fei Wang, Chunhong Zhang
INTRODUCTION: Poststroke depression is a serious and common complication of stroke, especially the ischemic poststroke depression. Antidepressants are used in poststroke depression, and acupuncture may be an alternative approach. However, the efficacy and mechanism of acupuncture for poststroke depression has not been confirmed. METHODS/DESIGN: This is a multicenter, central-randomized, single-blind, sham-controlled clinical trial. We will allocate 208 subjects aged between 40 and 80 years old, diagnosed with initial poststroke depression (PSD) within 6 months to 2 groups randomly in a ratio of 1:1...
February 2019: Medicine (Baltimore)
Shuo-Fang Ren, Hong Yu, Ying-Qiang Guo, Hai Yu
INTRODUCTION: Many studies have found that volatile anesthetics are associated with improved clinical outcomes for adults undergoing coronary artery bypass grafting. However, the effect of volatile anesthetics for adults after heart valve surgery has been unclear. So we conducted a meta-analysis of randomized controlled trials (RCTs) to explore whether the choice of an anesthetic regimen might influence patients' outcomes after valve surgery. EVIDENCE ACQUISITION: PubMed, Embase, and Cochrane Library were searched from inception to June 2018...
February 13, 2019: Minerva Anestesiologica
Jing Zhang, Jia Liu, Dan Li, Canfei Zhang, Ming Liu
BACKGROUND: The sudden loss of blood supply in ischemic stroke is associated with an increase of calcium ions within neurons. Inhibiting this increase could protect neurons and might reduce neurological impairment, disability, and handicap after stroke. OBJECTIVES: To assess the effects of calcium antagonists for reducing the risk of death or dependency after acute ischemic stroke. We investigated the influence of different drugs, dosages, routes of administration, time intervals after stroke, and trial design on the outcomes...
February 13, 2019: Cochrane Database of Systematic Reviews
R Vassar
BACE1 is the rate-limiting enzyme for the production of the Aβ peptide that forms amyloid plaques in Alzheimer's disease (AD). Small molecule inhibitors of BACE1 are being tested in clinical trials for AD, but the safety and efficacy of BACE1 inhibition has yet to be fully explored. Knockout of the Bace1 gene in the germline of mice causes multiple neurological phenotypes, suggesting that BACE1 inhibition could be toxic. However, these phenotypes could be the result of BACE1 deficiency during development rather than due to the lack of BACE1 function in the adult...
2019: Journal of Prevention of Alzheimer's Disease
Andrea Donti, Elisabetta Mariucci
Treatment of patients with cryptogenic stroke and a patent foramen ovale (PFO) has always been a matter of discussion. A clear pathogenic relationship is difficult to demonstrate in most cases, also because of the high prevalence of a PFO in the general population (25-30%). Early randomized trials failed to demonstrate a superiority of PFO transcatheter closure with respect to medical therapy alone but more recent data, coming from new randomized trials, strongly suggest that PFO closure associated with antiplatelet therapy is more effective than antiplatelet therapy alone in preventing recurrent stroke, with no increased risk of major adverse cardiovascular events in the follow-up; only a higher incidence of atrial fibrillation has been reported after PFO closure...
February 2019: Giornale Italiano di Cardiologia
Ioakeim Perros, Evangelos E Papalexakis, Richard Vuduc, Elizabeth Searles, Jimeng Sun
OBJECTIVE: Our aim is to extract clinically-meaningful phenotypes from longitudinal electronic health records (EHRs) of medically-complex children. This is a fragile set of patients consuming a disproportionate amount of pediatric care resources but who often end up with sub-optimal clinical outcome. The rise in available electronic health records (EHRs) provide a rich data source that can be used to disentangle their complex clinical conditions into concise, clinically-meaningful groups of characteristics...
February 8, 2019: Journal of Biomedical Informatics
Liping Zhang, LingYu Zhang, Lin Li, Christian Hölscher
Parkinson's disease (PD) is a progressive neurological motor control disorder. A key feature is the loss of midbrain dopaminergic neurons and the accumulation of aggregated alpha-synuclein (α-syn). No current treatment is on the market that slows or halts disease progression. Previous studies have shown that glucagon-like peptide-1 (GLP-1) receptor agonists have neuroprotective effects in animal models of PD. In addition, in a phase II clinical trial, the GLP-1 receptor agonist exendin-4 has shown good protective effects in PD patients...
2019: Journal of Parkinson's Disease
Gabriella Jacomelli, Eva Baldini, Claudia Mugnaini, Vanna Micheli, Giulia Bernardini, Annalisa Santucci
Lesch-Nyhan disease (LND) is a rare X-linked genetic disorder, with complete hypoxanthine-guanine phosphoribosyltransferase (HGPRT) deficiency, uric acid (UA), hypoxanthine and xanthine accumulation, and a devastating neurologic syndrome. UA excess, causing renal failure, is commonly decreased by xanthine oxidoreductase (XOR) inhibitors, such as allopurinol, yielding a xanthine and hypoxanthine increase. Xanthine accumulation may result in renal stones, while hypoxanthine excess seems involved in the neurological disorder...
January 2019: Journal of Inherited Metabolic Disease
Qian Ouyang, Feng Li, Yu Xie, Jianbang Han, Zhongfei Zhang, Zhiming Feng, Dazhuang Su, Xiaoxiong Zou, Yinqian Cai, Yuxi Zou, Yanping Tang, Xiaodan Jiang
Recent studies have indicated that stem cell transplantation may be effective in the treatment of ischemic stroke. Therefore, we performed a meta-analysis to evaluate the safety and efficacy of stem cell therapy for ischemic stroke in preclinical and clinical studies. In accordance with PRISMA guidelines, we searched the PubMed, Cochrane Library, Embase, Web of science, and Ovid databases from inception through May 2018. A total of 11 preclinical studies--18 independent interventions-were ultimately included...
February 11, 2019: Stem Cells and Development
Amir Shaban, Enrique C Leira
PURPOSE OF REVIEW: Neurological complications are common during cardiac procedures. The type of procedure influences the profile of neurological complications and their management. In this article, we review the different neurological complications encountered following cardiac procedures, and treatment strategies for managing those complications. RECENT FINDINGS: Recent clinical trials have expanded the time window of eligibility for mechanical thrombectomy and intravenous thrombolysis...
February 9, 2019: Current Neurology and Neuroscience Reports
Jade-Marie Corbett, Kwok M Ho, Stephen Honeybul
OBJECTIVEHematological abnormalities after severe traumatic brain injury (TBI) are common, and are associated with a poor outcome. Whether these abnormalities offer additional prognostic significance over and beyond validated TBI prognostic models is uncertain.METHODSThis retrospective cohort study compared the ability of admission hematological abnormalities to that of the IMPACT (International Mission for Prognosis and Analysis of Clinical Trials) prognostic model to predict 18-month neurological outcome of 388 patients who required a decompressive craniectomy after severe TBI, between 2004 and 2016, in Western Australia...
February 8, 2019: Journal of Neurosurgery
Philip L Perez, Sarah S Wang, Susan Heath, Jennifer Henderson-Sabes, Danielle Mizuiri, Leighton B Hinkley, Srikantan S Nagarajan, Paul S Larson, Steven W Cheung
OBJECTIVEThe object of this study was to define caudate nucleus locations responsive to intraoperative direct electrical stimulation for tinnitus loudness modulation and relate those locations to functional connectivity maps between caudate nucleus subdivisions and auditory cortex.METHODSSix awake study participants who underwent bilateral deep brain stimulation (DBS) electrode placement in the caudate nucleus as part of a phase I clinical trial were analyzed for tinnitus modulation in response to acute stimulation at 20 locations...
February 8, 2019: Journal of Neurosurgery
Manuri Gunawardena, Jeffrey M Rogers, Marcus A Stoodley, Michael K Morgan
OBJECTIVEPrevious trials rejected a role of extracranial-to-intracranial bypass surgery for managing symptomatic atheromatous disease. However, hemodynamic insufficiency may still be a rationale for surgery, provided the bypass can be performed with low morbidity and patency is robust.METHODSConsecutive patients undergoing bypass surgery for symptomatic non-moyamoya intracranial arterial stenosis or occlusion were retrospectively identified. The clinical course and surgical outcomes of the cohort were evaluated at 6 weeks, 6 months, and annually thereafter...
February 8, 2019: Journal of Neurosurgery
Martine E Bol, Martje M Suverein, Roberto Lorusso, Thijs S R Delnoij, George J Brandon Bravo Bruinsma, Luuk Otterspoor, Marijn Kuijpers, Ka Yan Lam, Alexander P J Vlaar, Carlos V Elzo Kraemer, Joris J van der Heijden, Erik Scholten, Antoine H G Driessen, José M Montero Cabezas, Saskia Z H Rittersma, Bram G Heijnen, Fabio S Taccone, Brigitte Essers, Tammo Delhaas, Patrick W Weerwind, Paul M H J Roekaerts, Jos G Maessen, Marcel C G van de Poll
Return of spontaneous circulation occurs in less than 10% of patients with cardiac arrest undergoing cardiopulmonary resuscitation (CPR) for more than 15 minutes. Studies suggest that extracorporeal life support during cardiopulmonary resuscitation (ECPR) improves survival rate in these patients. These studies, however, are hampered by their non-randomized, observational design and are mostly single-center. A multicenter, randomized controlled trial is urgently warranted to evaluate the effectiveness of ECPR...
December 14, 2018: American Heart Journal
Charles S Cox, Jennifer Juranek, Supinder Bedi
Clinical trials for traumatic brain injury (TBI) have not successfully produced a new therapeutic for neuroprotection or neurorestoration, despite multiple attempts. Stem cell-based therapies and/or cellular therapies have been developed over the past 20 years such that clinical trials are now in Phase II and III stages for neurologic diseases such as TBI and stroke. Many of the vexing issues from past clinical failures still exist today, namely, preclinical data that may not translate to clinical trial because of design and injury heterogeneity that poorly stratifies enrolled patients...
February 2019: Transfusion
John C Feemster, Kevin L Smith, Stuart J McCarter, Erik K St Louis
Trauma-associated sleep disorder (TASD) is a parasomnia sharing characteristics of post-traumatic stress disorder (PTSD) and REM sleep behavior disorder (RBD) including dream-enactment behavior (DEB). Here we report REM sleep without atonia (RSWA) and other neurological features in a patient with complex vocal and motor DEB following traumatic combat military exposure. Post-discharge, his wife observed frequent yelling and jerking during sleep with dream mentation reminiscent of traumatic military experiences...
February 4, 2019: Journal of Clinical Sleep Medicine: JCSM: Official Publication of the American Academy of Sleep Medicine
Fernanda Gubert, Igor Bonacossa-Pereira, Ana B Decotelli, Michelle Furtado, Andreia Vasconcelos-Dos-Santos, Rosalia Mendez-Otero, Marcelo F Santiago
Amyotrophic lateral sclerosis (ALS) is a chronic degenerative disease that mainly affects motor neurons, leading to progressive paralysis and death. Recently, cell therapy has emerged as a therapeutic alternative for several neurological diseases, including ALS, and bone-marrow cells are one of the major cell sources. Considering the importance of pre-clinical trials to determine the best therapeutic protocol and the hope of translating this protocol to the clinical setting, we tested bone-marrow mononuclear cell (BMMC) therapy administered by different routes in the SOD1G93A model of ALS...
February 5, 2019: Brain Research
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