Building a prognostic tool for disorders of consciousness: protocol for a multimodal imaging study (IMAGINA study)

Background In the last decades, advances in Intensive Care Unit management have led to decreased mortality. However, significant morbidity remains as patients survive after a lesional coma with uncertain quality of awakening and high risk of functional disability. Predicting this level of recovery but also the functional disability of those who will awake constitutes a major challenge for medical, ethical and social perspectives. Among the huge heterogeneity of coma-related injuries, recognising the universality of a common functional pattern which may be focused on a final step of an integrated network would be of great interest for our understanding of disorders of consciousness. The objective of this study is to investigate the neural correlates of arousal and awareness in coma and post-coma to build a prognostic tool based on the detection of a common pattern between patients with a favourable versus an unfavourable outcome. Method/Design We will implement this objective in a translational approach which combines PET-MR imaging, neurophysiology, behavioural/clinical assessments and innovative statistical and computational analysis tools in patients with disorders of consciousness in Intensive Care Unit and in Rehabilitation Department. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study is funded by the Agence Nationale pour la Recherche (grant number ANR-18-CE15-0012). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: French ethics committee gave ethical approval for this work (CPP Nord Ouest II; [NCT04575454][1]) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04575454&atom=%2Fmedrxiv%2Fearly%2F2023%2F01%2F20%2F2023.01.19.23284810.atom