scholarly journals Acoustic trauma from continuous noise: Minimum exposures, issues in clinical trial design, and comments on magnetic resonance imaging exposures

2019 ◽  
Vol 146 (5) ◽  
pp. 3873-3878 ◽  
Author(s):  
Elliott H. Berger ◽  
Robert A. Dobie
Keyword(s):  
Magnetic Resonance Imaging ◽  
Clinical Trial ◽  
Magnetic Resonance ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Acoustic Trauma ◽  
Resonance Imaging ◽  
Continuous Noise

scholarly journals Paediatric acquired demyelinating syndromes: incidence, clinical and magnetic resonance imaging features

2012 ◽  
Vol 19 (1) ◽  
pp. 76-86 ◽  
Author(s):  
Michael Absoud ◽  
Ming J Lim ◽  
Wui K Chong ◽  
Christian G De Goede ◽  
Katharine Foster ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Clinical Trial Design ◽  
Acute Disseminated Encephalomyelitis ◽  
Incidence Rates ◽  
Imaging Features ◽  
Resonance Imaging ◽  
Contrast Imaging ◽  
Mri Features ◽  
First Onset

Objective: Changing trends in multiple sclerosis (MS) epidemiology may first be apparent in the childhood population affected with first onset acquired demyelinating syndromes (ADSs). We aimed to determine the incidence, clinical, investigative and magnetic resonance imaging (MRI) features of childhood central nervous system ADSs in the British Isles for the first time. Methods: We conducted a population active surveillance study. All paediatricians, and ophthalmologists ( n = 4095) were sent monthly reporting cards (September 2009–September 2010). International Paediatric MS Study Group 2007 definitions and McDonald 2010 MS imaging criteria were used for acute disseminated encephalomyelitis (ADEM), clinically isolated syndrome (CIS) and neuromyelitis optica (NMO). Clinicians completed a standard questionnaire and provided an MRI copy for review. Results: Card return rates were 90%, with information available for 200/222 positive notifications (90%). After exclusion of cases, 125 remained (age range 1.3–15.9), with CIS in 66.4%, ADEM in 32.0% and NMO in 1.6%. The female-to-male ratio in children older than 10 years ( n = 63) was 1.52:1 ( p = 0.045). The incidence of first onset ADS in children aged 1–15 years old was 9.83 per million children per year (95% confidence interval [CI] 8.18–11.71). A trend towards higher incidence rates of ADS in children of South Asian and Black ethnicity was observed compared with White children. Importantly, a number of MRI characteristics distinguished ADEM from CIS cases. Of CIS cases with contrast imaging, 26% fulfilled McDonald 2010 MS diagnostic criteria. Conclusions: We report the highest surveillance incidence rates of childhood ADS. Paediatric MS diagnosis at first ADS presentation has implications for clinical practice and clinical trial design.

scholarly journals Neuroplasticity induced by general anaesthesia: study protocol for a randomised cross-over clinical trial exploring the effects of sevoflurane and propofol on the brain – A 3-T magnetic resonance imaging study of healthy volunteers

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Signe Sloth Madsen ◽  
Kirsten Møller ◽  
Karsten Skovgaard Olsen ◽  
Mark Bitsch Vestergaard ◽  
Ulrich Lindberg ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Clinical Trial ◽  
Cognitive Function ◽  
Magnetic Resonance ◽  
Healthy Volunteers ◽  
General Anaesthesia ◽  
Well Being ◽  
Resonance Imaging ◽  
Link Type ◽  
The Brain

Abstract Background Although used extensively worldwide, the effects of general anaesthesia on the human brain remain largely elusive. Moreover, general anaesthesia may contribute to serious conditions or adverse events such as postoperative cognitive dysfunction and delirium. To understand the basic mechanisms of general anaesthesia, this project aims to study and compare possible de novo neuroplastic changes induced by two commonly used types of general anaesthesia, i.e. inhalation anaesthesia by sevoflurane and intravenously administered anaesthesia by propofol. In addition, we wish to to explore possible associations between neuroplastic changes, neuropsychological adverse effects and subjective changes in fatigue and well-being. Methods This is a randomised, participant- and assessor-blinded, cross-over clinical trial. Thirty healthy volunteers (male:female ratio 1:1) will be randomised to general anaesthesia by either sevoflurane or propofol. Multimodal magnetic resonance imaging (MRI) of the brain will be performed before and after general anaesthesia and repeated after 1 and 8 days. Each magnetic resonance imaging session will be accompanied by cognitive testing and questionnaires on fatigue and well-being. After a wash-out period of 4 weeks, the volunteers will receive the other type of anaesthetic (sevoflurane or propofol), followed by the same series of tests. Primary outcomes: changes in T1-weighted 3D anatomy and diffusion tensor imaging. Secondary outcomes: changes in resting-state functional magnetic resonance imaging, fatigue, well-being, cognitive function, correlations between magnetic resonance imaging findings and the clinical outcomes (questionnaires and cognitive function). Exploratory outcomes: changes in cerebral perfusion and oxygen metabolism, lactate, and response to visual stimuli. Discussion To the best of our knowledge, this is the most extensive and advanced series of studies with head-to-head comparison of two widely used methods for general anaesthesia. Recruitment was initiated in September 2019. Trial registration Approved by the Research Ethics Committee in the Capital Region of Denmark, ref. H-18028925 (6 September 2018). EudraCT and Danish Medicines Agency: 2018-001252-35 (23 March 2018). www.clinicaltrials.gov, ID: NCT04125121. Retrospectively registered on 10 October 2019.

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