CMU Neural Engineering Virtual Seminars
Seminar Title: Guidelines for validation of EEG biomarkers
Speaker: Dr. Sándor Beniczky MD, PhD, FEAN, FACNS, Professor, University of Copenhagen, Head of Clinical Neurophysiology Department, Danish Epilepsy Centre
Abstract: Advances in digital technology, signal analysis, and data science have led to a rapid increase in papers reporting EEG-based biomarkers. However, wide heterogeneity in study design and reporting poses challenges in assessing the reliability, validity and utility of these biomarkers. To assist researchers in designing and reporting validation studies of EEG biomarkers, and to help editors and regulatory bodies evaluate them, an international working group—under the auspices of the International Federation of Clinical Neurophysiology (IFCN) developed the Guidelines for Reporting EEG/Neurophysiology Biomarker Evaluation for Application to Neurology and Neuropsychiatry (GREENBEAN). EEG biomarker validation studies are classified into four phases, similarly to therapeutic studies. Phases 1-2 are preliminary and do not constitute formal validation. Phase 3 studies provide compelling evidence of validity, while phase 4 studies assess the clinical utility and generalizability of previously validated biomarkers within real-world settings. This lecture will review the definitions for each phase, along with a checklist of items to address and report.
About the Speaker: Sándor Beniczky MD PhD is board-certified neurologist, clinical neurophysiologist and epileptologist. He is professor at the University of Copenhagen, head of the Clinical Neurophysiology Department at the Danish Epilepsy Centre and he is the editor-in-chief of Epileptic Disorders. His main research interest are EEG in epilepsy, electromagnetic source imaging, seizure detection, automated analysis, artificial intelligence, standardization and quality-assurance. He has supervised 12 PhD students, and he authored over 300 peer-reviewed papers and 26 book chapters.