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      Modafinil In Debilitating fatigue After Stroke (MIDAS): study protocol for a randomised, double-blinded, placebo-controlled, crossover trial

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          Abstract

          Background

          Fatigue is a common symptom in stroke survivors for which there is currently no proven therapy. Modafinil is a wakefulness-promoting agent with established benefits in other disease models. We aim to test if modafinil will improve patient’s self-reported fatigue scores when compared to placebo and if therapy results in increased quality of life.

          Methods/design

          MIDAS is a phase II, single-centre, prospective, double-blinded, randomised, crossover trial of modafinil for the treatment of persistent fatigue in survivors of ischaemic stroke. The inclusion criteria will require an average score of 12 or more across all domains of the Multi-dimensional Fatigue Inventory (MFI-20) and the diagnosis of a stroke more than 6 months prior. Patients will be randomised 1:1 to receive either modafinil 200 mg daily or placebo for a period of 6 weeks, after which a crossover will occur where patients who are on modafinil will begin taking placebo and vice versa. The primary outcome will be improvement in fatigue as measured by the MFI-20. Secondary outcomes will include changes in the Fatigue Severity Scale, improved cognition measured using the Montreal Cognitive Assessment, improvement in mood as determined by the Depression, Anxiety and Stress Scale and improvement in each patient’s stroke-specific quality of life score. All participants will also undergo magnetic resonance imaging (MRI) at baseline, crossover and study conclusion to measure cerebral blood flow on arterial spin labelling and brain activity on resting state functional MRI. This study will comply with the CONSORT guidelines. The projected sample size requirement is 36 participants in a crossover trial giving a power of 80 % and a type-1 error rate of 0.05.

          Discussion

          MIDAS seeks to enhance the quality of life in stroke survivors by assisting or resolving stroke-associated fatigue.

          Trial registration

          ACTRN12615000350527, registered on the 17 April 2015.

          Protocol version 3, approved 16 June 2015.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s13063-016-1537-4) contains supplementary material, which is available to authorized users.

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          Most cited references12

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          Major depression in stroke patients. A 3-year longitudinal study.

          This prospective study was designed to examine the contributions of neurobiological, functional, and psychosocial factors to major depression after stroke. In addition, the prevalence and longitudinal course of major depression were studied. Major depression, functional ability, and social network were assessed repeatedly for a period of 3 years in a population-based cohort of 80 patients with acute stroke (mean age, 73 years). Cerebral atrophy and brain lesion parameters were determined from computed tomographic scans performed acutely and after 3 years. The prevalence of major depression was 25% at the acute stage and approximately the same at 3 months (31%). It decreased to 16% at 12 months, was 19% at 2 years, and increased to 29% at 3 years. The most important predictors of immediate major depression were left anterior brain lesion, dysphasia, and living alone. Dependence in activities of daily living was the most important predictor at 3 months. From 12 months on, the patient's having few social contacts outside the immediate family contributed most to depression, and at 3 years cerebral atrophy also contributed. At 1 year, 60% of the patients with early depression (0 to 3 months) had recovered; those not recovered at this follow-up had a high risk of development of chronic depression. The study has provided evidence of a differentiation of factors likely to be implicated in the development of depression after stroke based or the period of time since the stroke event.
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            Poststroke fatigue: a 2-year follow-up study of stroke patients in Sweden.

            Fatigue is common among stroke patients. This study determined the prevalence of fatigue among long-term survivors after stroke and what impact fatigue had on various aspects of daily life and on survival. This study was based on Riks-Stroke, a hospital-based national register for quality assessment of acute stroke events in Sweden. During the first 6 months of 1997, 8194 patients were registered in Riks-Stroke, and 5189 were still alive 2 years after the stroke. They were followed up by a mail questionnaire, to which 4023 (79%) responded. Patients who reported that they always felt depressed were excluded. To the question, "Do you feel tired?" 366 (10.0%) of the patients answered that they always felt tired, and an additional 1070 (29.2%) were often tired. Patients who always felt tired were on average older than the rest of the study population (74.5 versus 71.5 years, P<0.001); therefore, all subsequent analyses were age adjusted. Fatigue was an independent predictor for having to move into an institutional setting after stroke. Fatigue was also an independent predictor for being dependent in primary activities of daily living functions. Three years after stroke, patients with fatigue also had a higher case fatality rate. Fatigue is frequent and often severe, even late after stroke. It is associated with profound deterioration of several aspects of everyday life and with higher case fatality, but it usually receives little attention by healthcare professionals. Intervention studies are needed.
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              Fatigue, psychological and cognitive impairment following transient ischaemic attack and minor stroke: a systematic review.

              Transient ischaemic attack (TIA) and minor stroke are characterized by short-lasting symptoms; however, anecdotal and empirical evidence suggests that these patients experience ongoing cognitive/psychological impairment for which they are not routinely treated. The aims were (i) to investigate the prevalence and time course of fatigue, anxiety, depression, post-traumatic stress disorder(PTSD) and cognitive impairment following TIA/minor stroke; (ii) to explore the impact on quality of life (QoL), change in emotions and return to work; and (iii) to identify where further research is required and potentially inform an intervention study. A systematic review of MEDLINE, EMBASE, PSYCINFO, CINAHL, the Cochrane libraries and the grey literature between January 1993 and April 2013 was undertaken. Literature was screened and data were extracted by two independent reviewers. Studies were included of adult TIA/minor stroke participants with any of the outcomes of interest: fatigue, anxiety, depression, PTSD, cognitive impairment, QoL, change in emotions and return to work. Random-effects meta-analysis pooled outcomes by measurement tool. Searches identified 5976 records, 289 were assessed for eligibility and 31 studies were included. Results suggest high levels of cognitive impairment and depression post-TIA/minor stroke which decreased over time. However, frequencies varied between studies. Limited information was available on anxiety, PTSD and fatigue. Meta-analysis revealed that the measurement tool administered influenced the prevalence of cognitive impairment: Mini-Mental State Examination 17% [95% confidence interval (CI) 7, 26]; neuropsychological test battery 39% (95% CI 28, 50); Montreal Cognitive Assessment 54% (95% CI 43, 66). There is evidence to suggest that TIA/minor stroke patients may experience residual impairments; however, results should be interpreted with caution because of the few high quality studies. Notwithstanding, it is important to raise awareness of potential subtle but meaningful residual impairments.
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                Author and article information

                Contributors
                Tom.lillicrap@uon.edu.au
                venkatesh.krishnamurthy@hnehealth.nsw.gov.au
                john.attia@newcastle.edu.au
                michael.nilsson@hmri.com.au
                christopher.levi@hnehealth.nsw.gov.au
                mark.parsons@hnehealth.nsw.gov.au
                612 4042 0315 , Andrew.bivard@hotmail.com , andrew.bivard@newcastle.edu.au
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                17 August 2016
                17 August 2016
                2016
                : 17
                : 410
                Affiliations
                [1 ]Departments of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, NSW Australia
                [2 ]Hunter Medical Research Institute, University of Newcastle, Newcastle, NSW Australia
                Article
                1537
                10.1186/s13063-016-1537-4
                4989372
                27534856
                e8b6c78a-a184-4c65-8669-ad5e6b13e426
                © The Author(s). 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 21 January 2016
                : 3 August 2016
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000930, National Stroke Foundation;
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2016

                Medicine
                fatigue,ischaemic stroke,stroke recovery
                Medicine
                fatigue, ischaemic stroke, stroke recovery

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