Periodic Reporting for period 1 - DOC-BOX (Development of a multimodal toolbox to ensure a fast and reliable diagnosis of consciousness disorders)
Reporting period: 2024-01-01 to 2025-12-31
Disorders of consciousness (DOC) remain one of the most challenging conditions to assess and diagnose in modern clinical practice. Despite major advances in neuroscience, many patients emerging from coma continue to be misdiagnosed due to the limited sensitivity of existing bedside assessments, the complexity of neuroimaging and neurophysiological techniques, and the strict time constraints in hospital environments. This diagnostic uncertainty has profound consequences—not only for clinical management and rehabilitation planning, but also for families and caregivers who rely on accurate prognostic information to make critical decisions. DOC-BOX responds directly to these clinical, societal, and strategic needs by developing a comprehensive, fast, and easy‑to‑implement toolbox for evaluating consciousness. The project integrates behavioural, neuroimaging, and neurophysiological approaches into a set of standardized tools specifically adapted to real‑world clinical constraints. By offering methods that can be deployed rapidly at the bedside and in routine workflows in all clinical environments, DOC-BOX aims to significantly reduce misdiagnosis rates and improve the quality of care for this highly vulnerable population. By combining diverse data sources, disciplines, and stakeholder perspectives, the project is expected to produce evidence‑based guidelines and policy recommendations that will influence clinical standards at a European and international level. Its large‑scale, interdisciplinary data collection will also substantially advance scientific understanding of consciousness and its disorders. Overall, DOC-BOX aims not only to improve diagnostic accuracy, but also to lay the foundations for better long‑term care, more equitable access to advanced assessment tools, and a stronger alignment between scientific innovation and clinical reality. The anticipated impact—ranging from improved patient outcomes to strategic contributions to European health policy—positions the project as a major step forward in the field of DoC.
Across the reporting period, the project achieved major technical and scientific milestones, including the full translation and cross‑cultural adaptation of all behavioural and caregiver‑based diagnostic tools (SECONDs, BERA, FCM, SAFE, DoC‑feeling) and the development of a new clinical instrument, the ASC scale, based on expert consensus. Comprehensive methodological frameworks were finalised, enabling harmonised multicentre validation studies and coordinated data acquisition. Scientifically, the consortium produced the largest multimodal meta‑analysis to date on DoC biomarkers and initiated large‑scale PET, MRI, and EEG data collection across multiple centres, supported by hardware optimisation and the refinement of a standardised PET analysis pipeline. These achievements substantially advance the establishment of a robust, interoperable diagnostic toolbox for disorders of consciousness.
The project results indicate strong potential for clinical, scientific and technological impact. The development of fast, reliable behavioural tools and the emergence of candidate multimodal biomarkers can significantly improve diagnostic accuracy and reduce assessment times in routine care. The ongoing creation of standardized PET/MRI/EEG pipelines will facilitate widespread adoption by lowering the expertise barrier for clinicians. To ensure full uptake and long‑term success, the next steps include completing validation studies, extending multimodal datasets, strengthening collaborations with clinical sites for real‑world demonstration, and preparing the framework for regulatory alignment and standardization. Additional needs include continued efforts to integrate outputs into clinical guidelines and professional training.