PerBrain: a multimodal approach to personalized tracking of evolving state-of-consciousness in brain-injured patients: protocol of an international, multicentric, observational study

BMC Neurology

Study Protocol

M. Colombo¹  M. Bassi¹  M. Rosanova¹  S. Casarotto²  C. Valota²  N. Sobel³  T. M. Raiser⁴  L. Willacker⁴  M. Hohl⁴  A. Bender⁵  C. C. Derchi⁶  A. Comanducci⁶  E. Grill⁷  K. Kuehlmeyer⁸  J. D. Sitt⁹  E. Fló Rama⁹  A. Arzi^1,10  L. Belloli^1,11  D. Manasova^1,12  M. J. Rosenfelder^1,13 

[1]Department of Biomedical and Clinical Sciences, University of Milano, Milan, Italy

[2]Department of Biomedical and Clinical Sciences, University of Milano, Milan, Italy

[3]IRCCS Fondazione Don Carlo Gnocchi ONLUS, Milan, Italy

[4]Department of Brain Sciences, Weizmann Institute of Science, Rehovot, Israel

[5]Department of Neurology, University Hospital of the Ludwig-Maximilians-Universität München, Marchioninistr. 15, Munich, Germany

[6]Department of Neurology, University Hospital of the Ludwig-Maximilians-Universität München, Marchioninistr. 15, Munich, Germany

[7]Therapiezentrum Burgau, Hospital for Neurological Rehabilitation, Burgau, Germany

[8]IRCCS Fondazione Don Carlo Gnocchi ONLUS, Milan, Italy

[9]Institute for Medical Information Processing, Biometry and Epidemiology, Ludwig-Maximilians-Universität München, Munich, Germany

[10]German Center for Vertigo and Balance Disorders, Klinikum der Universität München, Munich, Germany

[11]Institute of Ethics, History and Theory of Medicine, Ludwig-Maximilians-Universität München, Munich, Germany

[12]Sorbonne Université, Institut du Cerveau - Paris Brain Institute - ICM, Inserm, CNRS, 75013, Paris, France

[13]Sorbonne Université, Institut du Cerveau - Paris Brain Institute - ICM, Inserm, CNRS, 75013, Paris, France

[14]Department of Medical Neurobiology and Department of Cognitive and Brain Sciences, The Hebrew University of Jerusalem, Jerusalem, Israel

[15]Sorbonne Université, Institut du Cerveau - Paris Brain Institute - ICM, Inserm, CNRS, 75013, Paris, France

[16]Laboratorio de Inteligencia Artificial Aplicada, Instituto de Ciencias de la Computación, Universidad de Buenos Aires, Buenos Aires, Argentina

[17]Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Ministry of Science, Technology and Innovation, Buenos Aires, Argentina

[18]Sorbonne Université, Institut du Cerveau - Paris Brain Institute - ICM, Inserm, CNRS, 75013, Paris, France

[19]Université Paris Cité, Paris, France

[20]Therapiezentrum Burgau, Hospital for Neurological Rehabilitation, Burgau, Germany

[21]Clinical and Biological Psychology, Institute of Psychology and Education, Ulm University, Ulm, Germany

关键词: Disorders of consciousness;    Multimodal neurodiagnostic;    Outcome prediction;    Caregiver well-being;    Machine learning;    Multicentric evaluation;    Family caregivers;    Personalized medicine;   

DOI  :  10.1186/s12883-022-02958-x

 received in 2022-09-07, accepted in 2022-11-01,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundDisorders of consciousness (DoC) are severe neurological conditions in which consciousness is impaired to various degrees. They are caused by injury or malfunction of neural systems regulating arousal and awareness. Over the last decades, major efforts in improving and individualizing diagnostic and prognostic accuracy for patients affected by DoC have been made, mainly focusing on introducing multimodal assessments to complement behavioral examination. The present EU-funded multicentric research project “PerBrain” is aimed at developing an individualized diagnostic hierarchical pathway guided by both behavior and multimodal neurodiagnostics for DoC patients.MethodsIn this project, each enrolled patient undergoes repetitive behavioral, clinical, and neurodiagnostic assessments according to a patient-tailored multi-layer workflow. Multimodal diagnostic acquisitions using state-of-the-art techniques at different stages of the patients’ clinical evolution are performed. The techniques applied comprise well-established behavioral scales, innovative neurophysiological techniques (such as quantitative electroencephalography and transcranial magnetic stimulation combined with electroencephalography), structural and resting-state functional magnetic resonance imaging, and measurements of physiological activity (i.e. nasal airflow respiration). In addition, the well-being and treatment decision attitudes of patients’ informal caregivers (primarily family members) are investigated. Patient and caregiver assessments are performed at multiple time points within one year after acquired brain injury, starting at the acute disease phase.DiscussionAccurate classification and outcome prediction of DoC are of crucial importance for affected patients as well as their caregivers, as individual rehabilitation strategies and treatment decisions are critically dependent on the latter. The PerBrain project aims at optimizing individual DoC diagnosis and accuracy of outcome prediction by integrating data from the suggested multimodal examination methods into a personalized hierarchical diagnosis and prognosis procedure. Using the parallel tracking of both patients’ neurological status and their caregivers’ mental situation, well-being, and treatment decision attitudes from the acute to the chronic phase of the disease and across different countries, this project aims at significantly contributing to the current clinical routine of DoC patients and their family members.Trial registrationClinicalTrials.gov, NCT04798456. Registered 15 March 2021 – Retrospectively registered.

【 授权许可】

CC BY   
© The Author(s) 2022