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Progression of MRI markers in cerebral small vessel disease: Sample size considerations for clinical trials

Benjamin, P; Zeestraten, E; Lambert, C; Ster, IC; Williams, OA; Lawrence, AJ; Patel, B; ... Markus, HS; + view all (2016) Progression of MRI markers in cerebral small vessel disease: Sample size considerations for clinical trials. Journal of Cerebral Blood Flow & Metabolism , 36 (1) pp. 228-240. 10.1038/jcbfm.2015.113. Green open access

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Abstract

Detecting treatment efficacy using cognitive change in trials of cerebral small vessel disease (SVD) has been challenging, making the use of surrogate markers such as magnetic resonance imaging (MRI) attractive. We determined the sensitivity of MRI to change in SVD and used this information to calculate sample size estimates for a clinical trial. Data from the prospective SCANS (St George’s Cognition and Neuroimaging in Stroke) study of patients with symptomatic lacunar stroke and confluent leukoaraiosis was used (n ¼ 121). Ninety-nine subjects returned at one or more time points. Multimodal MRI and neuropsychologic testing was performed annually over 3 years. We evaluated the change in brain volume, T2 white matter hyperintensity (WMH) volume, lacunes, and white matter damage on diffusion tensor imaging (DTI). Over 3 years, change was detectable in all MRI markers but not in cognitive measures. WMH volume and DTI parameters were most sensitive to change and therefore had the smallest sample size estimates. MRI markers, particularly WMH volume and DTI parameters, are more sensitive to SVD progression over short time periods than cognition. These markers could significantly reduce the size of trials to screen treatments for efficacy in SVD, although further validation from longitudinal and intervention studies is required.

Type: Article
Title: Progression of MRI markers in cerebral small vessel disease: Sample size considerations for clinical trials
Open access status: An open access version is available from UCL Discovery
DOI: 10.1038/jcbfm.2015.113
Publisher version: http://dx.doi.org/10.1038/jcbfm.2015.113
Language: English
Additional information: This article is distributed under the terms of the Creative Commons Attribution 3.0 License (http://www.creativecommons.org/licenses/by/3.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
Keywords: Science & Technology, Life Sciences & Biomedicine, Endocrinology & Metabolism, Hematology, Neurosciences, Neurosciences & Neurology, Cerebral small vessel disease, clinical trials, diffusion tensor imaging, magnetic resonance imaging, vascular cognitive impairment, MATTER LESION PROGRESSION, COGNITIVE DECLINE, MULTIPLE-SCLEROSIS, BRAIN ATROPHY, IMPAIRMENT, CADASIL, HYPERINTENSITIES, LACUNES, STROKE, VOLUME
UCL classification: UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology > Imaging Neuroscience
URI: https://discovery.ucl.ac.uk/id/eprint/10044842
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