Structural brain changes in hyperthyroid Graves’ disease: protocol for an ongoing longitudinal, case-controlled study in Göteborg, Sweden—the CogThy project

Introduction Cognitive impairment and reduced well-being are common manifestations of Graves’ disease (GD). These symptoms are not only prevalent during the active phase of the disease but also often prevail for a long time after hyperthyroidism is considered cured. The pathogenic mechanisms involve...

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Main Authors: Rolf A Heckemann, Mats Olof Holmberg, Helge Malmgren, Peter Berglund, Lina Bunketorp-Käll, Birgitta Johansson, Niklas Klasson, Erik Olsson, Simon Skau, Helena Nystrom Filipsson
Format: Article
Language:English
Published: BMJ Publishing Group 2019-11-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/9/11/e031168.full
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author Rolf A Heckemann
Mats Olof Holmberg
Helge Malmgren
Peter Berglund
Lina Bunketorp-Käll
Birgitta Johansson
Niklas Klasson
Erik Olsson
Simon Skau
Helena Nystrom Filipsson
author_facet Rolf A Heckemann
Mats Olof Holmberg
Helge Malmgren
Peter Berglund
Lina Bunketorp-Käll
Birgitta Johansson
Niklas Klasson
Erik Olsson
Simon Skau
Helena Nystrom Filipsson
author_sort Rolf A Heckemann
collection DOAJ
description Introduction Cognitive impairment and reduced well-being are common manifestations of Graves’ disease (GD). These symptoms are not only prevalent during the active phase of the disease but also often prevail for a long time after hyperthyroidism is considered cured. The pathogenic mechanisms involved in these brain-derived symptoms are currently unknown. The overall aim of the CogThy study is to identify the mechanism behind cognitive impairment to be able to recognise GD patients at risk.Methods and analysis The study is a longitudinal, single-centre, case-controlled study conducted in Göteborg, Sweden on premenopausal women with newly diagnosed GD. The subjects are examined: at referral, at inclusion and then every 3.25 months until 15 months. Examinations include: laboratory measurements; eye evaluation; neuropsychiatric and neuropsychological testing; structural MRI of the whole brain, orbits and medial temporal lobe structures; functional near-infrared spectroscopy of the cerebral prefrontal cortex and self-assessed quality of life questionnaires. The primary outcome measure is the change in medial temporal lobe structure volume. Secondary outcome measures include neuropsychological, neuropsychiatric, hormonal and autoantibody variables. The study opened for inclusion in September 2012 and close for inclusion in October 2019. It will provide novel information on the effect of GD on medial temporal lobe structures and cerebral cortex functionality as well as whether these changes are associated with cognitive and affective impairment, hormonal levels and/or autoantibody levels. It should lead to a broader understanding of the underlying pathogenesis and future treatment perspectives.Ethics and dissemination The study has been reviewed and approved by the Regional Ethical Review Board in Göteborg, Sweden. The results will be actively disseminated through peer-reviewed journals, national and international conference presentations and among patient organisations after an appropriate embargo time.Trial registration number 44321 at the public project database for research and development in Västra Götaland County, Sweden (https://www.researchweb.org/is/vgr/project/44321).
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spelling doaj-art-47198eafd9214f77a75e10ef76bb7f582024-12-13T00:10:09ZengBMJ Publishing GroupBMJ Open2044-60552019-11-0191110.1136/bmjopen-2019-031168Structural brain changes in hyperthyroid Graves’ disease: protocol for an ongoing longitudinal, case-controlled study in Göteborg, Sweden—the CogThy projectRolf A Heckemann0Mats Olof Holmberg1Helge Malmgren2Peter Berglund3Lina Bunketorp-Käll4Birgitta Johansson5Niklas Klasson6Erik Olsson7Simon Skau8Helena Nystrom Filipsson9Department of Medical Radiation Sciences, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden1 ANOVA, Karolinska University Hospital, Stockholm, Sweden2 Institute of Medicine, University of Gothenburg, Sahlgrenska Academy, Göteborg, Sweden4 Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg, Sweden5 Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg, Sweden4 Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg, Sweden3 MedTech West, University of Gothenburg, Sahlgrenska University Hospital, Göteborg, Sweden2 Institute of Medicine, University of Gothenburg, Sahlgrenska Academy, Göteborg, Sweden3 MedTech West, University of Gothenburg, Sahlgrenska University Hospital, Göteborg, Sweden2 Institute of Medicine, University of Gothenburg, Sahlgrenska Academy, Göteborg, SwedenIntroduction Cognitive impairment and reduced well-being are common manifestations of Graves’ disease (GD). These symptoms are not only prevalent during the active phase of the disease but also often prevail for a long time after hyperthyroidism is considered cured. The pathogenic mechanisms involved in these brain-derived symptoms are currently unknown. The overall aim of the CogThy study is to identify the mechanism behind cognitive impairment to be able to recognise GD patients at risk.Methods and analysis The study is a longitudinal, single-centre, case-controlled study conducted in Göteborg, Sweden on premenopausal women with newly diagnosed GD. The subjects are examined: at referral, at inclusion and then every 3.25 months until 15 months. Examinations include: laboratory measurements; eye evaluation; neuropsychiatric and neuropsychological testing; structural MRI of the whole brain, orbits and medial temporal lobe structures; functional near-infrared spectroscopy of the cerebral prefrontal cortex and self-assessed quality of life questionnaires. The primary outcome measure is the change in medial temporal lobe structure volume. Secondary outcome measures include neuropsychological, neuropsychiatric, hormonal and autoantibody variables. The study opened for inclusion in September 2012 and close for inclusion in October 2019. It will provide novel information on the effect of GD on medial temporal lobe structures and cerebral cortex functionality as well as whether these changes are associated with cognitive and affective impairment, hormonal levels and/or autoantibody levels. It should lead to a broader understanding of the underlying pathogenesis and future treatment perspectives.Ethics and dissemination The study has been reviewed and approved by the Regional Ethical Review Board in Göteborg, Sweden. The results will be actively disseminated through peer-reviewed journals, national and international conference presentations and among patient organisations after an appropriate embargo time.Trial registration number 44321 at the public project database for research and development in Västra Götaland County, Sweden (https://www.researchweb.org/is/vgr/project/44321).https://bmjopen.bmj.com/content/9/11/e031168.full
spellingShingle Rolf A Heckemann
Mats Olof Holmberg
Helge Malmgren
Peter Berglund
Lina Bunketorp-Käll
Birgitta Johansson
Niklas Klasson
Erik Olsson
Simon Skau
Helena Nystrom Filipsson
Structural brain changes in hyperthyroid Graves’ disease: protocol for an ongoing longitudinal, case-controlled study in Göteborg, Sweden—the CogThy project
BMJ Open
title Structural brain changes in hyperthyroid Graves’ disease: protocol for an ongoing longitudinal, case-controlled study in Göteborg, Sweden—the CogThy project
title_full Structural brain changes in hyperthyroid Graves’ disease: protocol for an ongoing longitudinal, case-controlled study in Göteborg, Sweden—the CogThy project
title_fullStr Structural brain changes in hyperthyroid Graves’ disease: protocol for an ongoing longitudinal, case-controlled study in Göteborg, Sweden—the CogThy project
title_full_unstemmed Structural brain changes in hyperthyroid Graves’ disease: protocol for an ongoing longitudinal, case-controlled study in Göteborg, Sweden—the CogThy project
title_short Structural brain changes in hyperthyroid Graves’ disease: protocol for an ongoing longitudinal, case-controlled study in Göteborg, Sweden—the CogThy project
title_sort structural brain changes in hyperthyroid graves disease protocol for an ongoing longitudinal case controlled study in goteborg sweden the cogthy project
url https://bmjopen.bmj.com/content/9/11/e031168.full
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