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      A Role for New Brain Magnetic Resonance Imaging Modalities in Daily Clinical Practice: Protocol of the Prediction of Cognitive Recovery After Stroke (PROCRAS) Study

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          Abstract

          Background

          Cognitive impairment is common after acute ischemic stroke, affecting up to 75% of the patients. About half of the patients will show recovery, whereas the others will remain cognitively impaired or deteriorate. It is difficult to predict these different cognitive outcomes.

          Objective

          The objective of this study is to investigate whether diffusion tensor imaging–based measures of brain connectivity predict cognitive recovery after 1 year, in addition to patient characteristics and stroke severity. A specific premise of the Prediction of Cognitive Recovery After Stroke (PROCRAS) study is that it is conducted in a daily practice setting.

          Methods

          The PROCRAS study is a prospective, mono-center cohort study conducted in a large teaching hospital in the Netherlands. A total of 350 patients suffering from an ischemic stroke who screen positive for cognitive impairment on the Montreal Cognitive Assessment (MoCA<26) in the acute stage will undergo a 3Tesla-Magnetic Resonance Imaging (3T-MRI) with a diffusion-weighted sequence and a neuropsychological assessment. Patients will be classified as being unimpaired, as having a mild vascular cognitive disorder, or as having a major vascular cognitive disorder. One year after stroke, patients will undergo follow-up neuropsychological assessment. The primary endpoint is recovery of cognitive function 1 year after stroke in patients with a confirmed poststroke cognitive disorder. The secondary endpoint is deterioration of cognitive function in the first year after stroke.

          Results

          The study is already ongoing for 1.5 years, and thus far, 252 patients have provided written informed consent. Final results are expected in June 2019.

          Conclusions

          The PROCRAS study will show the additional predictive value of diffusion tensor imaging-based measures of brain connectivity for cognitive outcome at 1 year in patients with a poststroke cognitive disorder in a daily clinical practice setting.

          Registered Report Identifier

          RR1-10.2196/9431

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          Most cited references49

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          Cumulative illness rating scale.

          B S Linn, M W Linn, L Gurel (1968)
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            Post-Stroke Depression: A Review.

            Robert G. Robinson, Ricardo E. Jorge (2016)
            Poststroke depression (PSD) has been recognized by psychiatrists for more than 100 years, but controlled systematic studies did not begin until the 1970s. Meta-analyses addressing almost all major clinical issues in the field have emerged because of the relatively small number of patients included in some stroke studies. In order to build large databases, these meta-analyses have merged patients with rigorously assessed mood disorders with major depressive features with patients scoring above arbitrary cutoff points on depression rating scales, thus missing important findings such as cognitive impairment associated with major but not minor depression. Nevertheless, PSD occurs in a significant number of patients and constitutes an important complication of stroke, leading to greater disability as well as increased mortality. The most clinically important advances, however, have been in the treatment and prevention of PSD. Recent meta-analyses of randomized controlled trials for the treatment of PSD have demonstrated the efficacy of antidepressants. Similarly, randomized controlled trials for prevention of PSD have shown that antidepressants significantly decrease the incidence of PSD compared with placebo. Early antidepressant treatment of PSD appears to enhance both physical and cognitive recovery from stroke and might increase survival up to 10 years following stroke. There has also been progress in understanding the pathophysiology of PSD. Inflammatory processes might be associated with the onset of at least some depressive symptoms. In addition, genetic and epigenetic variations, white matter disease, cerebrovascular deregulation, altered neuroplasticity, and changes in glutamate neurotransmission might be relevant etiological factors. Further elucidation of the mechanism of PSD may ultimately lead to specific targeted treatments.
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              Development of a stroke-specific quality of life scale.

              L Williams, M. Weinberger, L E Harris … (1999)
              Clinical stroke trials are increasingly measuring patient-centered outcomes such as functional status and health-related quality of life (HRQOL). No stroke-specific HRQOL measure is currently available. This study presents the initial development of a valid, reliable, and responsive stroke-specific quality of life (SS-QOL) measure, for use in stroke trials. Domains and items for the SS-QOL were developed from patient interviews. The SS-QOL, Short Form 36, Beck Depression Inventory, National Institutes of Health Stroke Scale, and Barthel Index were administered to patients 1 and 3 months after ischemic stroke. Items were eliminated with the use of standard psychometric criteria. Construct validity was assessed by comparing domain scores with similar domains of established measures. Domain responsiveness was assessed with standardized effect sizes. All 12 domains of the SS-QOL were unidimensional. In the final 49-item scale, all domains demonstrated excellent internal reliability (Cronbach's alpha values for each domain >/=0.73). Most domains were moderately correlated with similar domains of established outcome measures (r2 range, 0.3 to 0.5). Most domains were responsive to change (standardized effect sizes >0.4). One- and 3-month SS-QOL scores were associated with patients' self-report of HRQOL compared with before their stroke (P<0.001). The SS-QOL measures HRQOL, its primary underlying construct, in stroke patients. Preliminary results regarding the reliability, validity, and responsiveness of the SS-QOL are encouraging. Further studies in diverse stroke populations are needed.
              Article 0 comments Cited 192 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Hugo P Aben: On behalf of : PROCRAS study group
                Elisabeth Tweesteden HospitalDepartment of NeurologyPO Box 90151Tilburg, 5000 LCNetherlands31 135392552h.aben@etz.nl
                ORCID: http://orcid.org/0000-0003-3032-8843
                Journal
                Journal ID (nlm-ta): JMIR Res Protoc
                Journal ID (iso-abbrev): JMIR Res Protoc
                Journal ID (publisher-id): ResProt
                Title: JMIR Research Protocols
                Publisher: JMIR Publications (Toronto, Canada )
                ISSN (Electronic): 1929-0748
                Publication date Collection: May 2018
                Publication date (Electronic): 28 May 2018
                Volume: 7
                Issue: 5
                Electronic Location Identifier: e127
                Affiliations
                [1] 1 Elisabeth Tweesteden Hospital Department of Neurology Tilburg Netherlands
                [2] 2 Brain Center Rudolf Magnus Department of Neurology University Medical Center Utrecht Utrecht Netherlands
                [3] 3 Physical Therapy Science & Sports, Brain Center Rudolf Magnus Department of Rehabilitation University Medical Center Utrecht Utrecht Netherlands
                [4] 4 Department of Clinical and Experimental Neuropsychology University of Groningen Groningen Netherlands
                [5] 5 Department of Radiology University Medical Center Utrecht Utrecht Netherlands
                [6] 6 Department of Radiology Leiden University Medical Center Leiden Netherlands
                Author notes
                Corresponding Author: Hugo P Aben h.aben@ 123456etz.nl
                Author information
                http://orcid.org/0000-0003-3032-8843
                http://orcid.org/0000-0002-2566-7122
                http://orcid.org/0000-0002-5955-8012
                http://orcid.org/0000-0002-6477-0763
                http://orcid.org/0000-0003-0759-8407
                http://orcid.org/0000-0001-6862-2496
                http://orcid.org/0000-0002-6031-2255
                Article
                Publisher ID: v7i5e127
                DOI: 10.2196/resprot.9431
                PMC ID: 5997934
                PubMed ID: 29807883
                SO-VID: ff8cc90a-f22c-4b86-a199-df0f1aca880f
                Copyright © ©Hugo P Aben, Yael D Reijmer, Johanna MA Visser-Meily, Jacoba M Spikman, Jeroen de Bresser, Geert Jan Biessels, Paul LM de Kort. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 28.05.2018.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                Date received : 16 November 2017
                Date revision requested : 11 January 2018
                Date revision received : 7 March 2018
                Date accepted : 19 March 2018
                Categories
                Subject: Protocol
                Subject: Protocol

                Keywords: stroke,brain infarction,cognitive dysfunction,diffusion magnetic resonance imaging,anisotropy,diffusion tensor imaging
                Data availability:
                Keywords: stroke, brain infarction, cognitive dysfunction, diffusion magnetic resonance imaging, anisotropy, diffusion tensor imaging

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