Investigating imaging network markers of cognitive dysfunction and pharmacoresistance in newly diagnosed epilepsy: a protocol for an observational cohort study in the UK

Introduction Epilepsy is one of the most common serious brain disorders, characterised by seizures that severely affect a person’s quality of life and, frequently, their cognitive and mental health. Although most existing work has examined chronic epilepsy, newly diagnosed patients present a unique...

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Main Authors: Anthony Guy Marson, Marta García-Fiñana, Christophe de Bézenac, Gus Baker, Perry Moore, Nicola Leek, Rajiv Mohanraj, Leonardo Bonilha, Mark Richardson, Simon Keller
Format: Article
Language:English
Published: BMJ Publishing Group 2019-10-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/9/10/e034347.full
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author Anthony Guy Marson
Marta García-Fiñana
Christophe de Bézenac
Gus Baker
Perry Moore
Nicola Leek
Rajiv Mohanraj
Leonardo Bonilha
Mark Richardson
Simon Keller
author_facet Anthony Guy Marson
Marta García-Fiñana
Christophe de Bézenac
Gus Baker
Perry Moore
Nicola Leek
Rajiv Mohanraj
Leonardo Bonilha
Mark Richardson
Simon Keller
author_sort Anthony Guy Marson
collection DOAJ
description Introduction Epilepsy is one of the most common serious brain disorders, characterised by seizures that severely affect a person’s quality of life and, frequently, their cognitive and mental health. Although most existing work has examined chronic epilepsy, newly diagnosed patients present a unique opportunity to understand the underlying biology of epilepsy and predict effective treatment pathways. The objective of this prospective cohort study is to examine whether cognitive dysfunction is associated with measurable brain architectural and connectivity impairments at diagnosis and whether the outcome of antiepileptic drug treatment can be predicted using these measures.Methods and analysis 107 patients with newly diagnosed focal epilepsy from two National Health Service Trusts and 48 healthy controls (aged 16–65 years) will be recruited over a period of 30 months. Baseline assessments will include neuropsychological evaluation, structural and functional Magnetic Resonance Imaging (MRI), Electroencephalography (EEG), and a blood and saliva sample. Patients will be followed up every 6 months for a 24-month period to assess treatment outcomes. Connectivity- and network-based analyses of EEG and MRI data will be carried out and examined in relation to neuropsychological evaluation and patient treatment outcomes. Patient outcomes will also be investigated with respect to analysis of molecular isoforms of high mobility group box-1 from blood and saliva samples.Ethics and dissemination This study was approved by the North West, Liverpool East Research Ethics Committee (19/NW/0384) through the Integrated Research Application System (Project ID 260623). Health Research Authority (HRA) approval was provided on 22 August 2019. The project is sponsored by the UoL (UoL001449) and funded by a UK Medical Research Council (MRC) research grant (MR/S00355X/1). Findings will be presented at national and international meetings and conferences and published in peer-reviewed journals.Trial registration number IRAS Project ID 260623.
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spelling doaj-art-1e7041a64da0422ea6bf4225dbe26c5b2025-08-20T01:55:39ZengBMJ Publishing GroupBMJ Open2044-60552019-10-0191010.1136/bmjopen-2019-034347Investigating imaging network markers of cognitive dysfunction and pharmacoresistance in newly diagnosed epilepsy: a protocol for an observational cohort study in the UKAnthony Guy Marson0Marta García-Fiñana1Christophe de Bézenac2Gus Baker3Perry Moore4Nicola Leek5Rajiv Mohanraj6Leonardo Bonilha7Mark Richardson8Simon Keller912 Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UKDepartment of Health Data Science, University of Liverpool, Liverpool, UKInstitute of Systems, Molecular, Integrated Biology, Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK9 Molecular and Clinical Pharmacology, University of Liverpool, Faculty of Health and Life Sciences, Liverpool, UKDeptment of Clinical Neuropsychology, The Walton Centre NHS Foundation Trust, Liverpool, UK1 Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UKNeurology, Manchester Centre for Clinical Neurosciences, Salford Royal Hospital, Salford, UK4 Department of Neurology, University of South Carolina System, Columbia, South Carolina, USA6 Institute of Psychiatry, Psychology and Neuroscience, King`s College London, London, UKPharmacy Department, Liverpool University Hospitals NHS Foundation Trust, Liverpool, Liverpool, UKIntroduction Epilepsy is one of the most common serious brain disorders, characterised by seizures that severely affect a person’s quality of life and, frequently, their cognitive and mental health. Although most existing work has examined chronic epilepsy, newly diagnosed patients present a unique opportunity to understand the underlying biology of epilepsy and predict effective treatment pathways. The objective of this prospective cohort study is to examine whether cognitive dysfunction is associated with measurable brain architectural and connectivity impairments at diagnosis and whether the outcome of antiepileptic drug treatment can be predicted using these measures.Methods and analysis 107 patients with newly diagnosed focal epilepsy from two National Health Service Trusts and 48 healthy controls (aged 16–65 years) will be recruited over a period of 30 months. Baseline assessments will include neuropsychological evaluation, structural and functional Magnetic Resonance Imaging (MRI), Electroencephalography (EEG), and a blood and saliva sample. Patients will be followed up every 6 months for a 24-month period to assess treatment outcomes. Connectivity- and network-based analyses of EEG and MRI data will be carried out and examined in relation to neuropsychological evaluation and patient treatment outcomes. Patient outcomes will also be investigated with respect to analysis of molecular isoforms of high mobility group box-1 from blood and saliva samples.Ethics and dissemination This study was approved by the North West, Liverpool East Research Ethics Committee (19/NW/0384) through the Integrated Research Application System (Project ID 260623). Health Research Authority (HRA) approval was provided on 22 August 2019. The project is sponsored by the UoL (UoL001449) and funded by a UK Medical Research Council (MRC) research grant (MR/S00355X/1). Findings will be presented at national and international meetings and conferences and published in peer-reviewed journals.Trial registration number IRAS Project ID 260623.https://bmjopen.bmj.com/content/9/10/e034347.full
spellingShingle Anthony Guy Marson
Marta García-Fiñana
Christophe de Bézenac
Gus Baker
Perry Moore
Nicola Leek
Rajiv Mohanraj
Leonardo Bonilha
Mark Richardson
Simon Keller
Investigating imaging network markers of cognitive dysfunction and pharmacoresistance in newly diagnosed epilepsy: a protocol for an observational cohort study in the UK
BMJ Open
title Investigating imaging network markers of cognitive dysfunction and pharmacoresistance in newly diagnosed epilepsy: a protocol for an observational cohort study in the UK
title_full Investigating imaging network markers of cognitive dysfunction and pharmacoresistance in newly diagnosed epilepsy: a protocol for an observational cohort study in the UK
title_fullStr Investigating imaging network markers of cognitive dysfunction and pharmacoresistance in newly diagnosed epilepsy: a protocol for an observational cohort study in the UK
title_full_unstemmed Investigating imaging network markers of cognitive dysfunction and pharmacoresistance in newly diagnosed epilepsy: a protocol for an observational cohort study in the UK
title_short Investigating imaging network markers of cognitive dysfunction and pharmacoresistance in newly diagnosed epilepsy: a protocol for an observational cohort study in the UK
title_sort investigating imaging network markers of cognitive dysfunction and pharmacoresistance in newly diagnosed epilepsy a protocol for an observational cohort study in the uk
url https://bmjopen.bmj.com/content/9/10/e034347.full
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