Therapy response prediction of focal cortex stimulation based on clinical parameters: a multicentre, non-interventional study protocol
Andreas Schulze-Bonhage,
Ann Mertens,
Felix von Podewils,
Martin Hirsch,
Yaroslav Winter,
Susanne Knake,
Ekaterina Pataraia,
Thomas Mayer,
Yvonne G Weber,
Rainer Surges,
Jan Wagner,
Hajo M Hamer,
Tim Wehner,
Christoph Baumgartner,
Lukas Imbach,
Bernhard J Steinhoff,
Sotirios Kalousios,
Jürgen Hesser,
Matthias Dümpelmann,
Elisabeth Kaufmann,
Josua Kegele,
Georg Leonhardt,
Carlos M Quesada,
Berthold R Voges
Affiliations
Andreas Schulze-Bonhage
1 Epilepsy Center, Neurocenter, University Medical Center, University of Freiburg, Freiburg, Germany
Ann Mertens
12 Department of Neurology, 4Brain, Ghent University Hospital, Ghent, Belgium
Felix von Podewils
15 Department of Neurology, Epilepsy Center, University Medicine Greifswald, Greifswald, Germany
Martin Hirsch
1 Epilepsy Center, Neurocenter, University Medical Center, University of Freiburg, Freiburg, Germany
Yaroslav Winter
23 Department of Neurology, Mainz Comprehensive Epilepsy and Sleep Medicine Center, University Medical Center of the Johannes Gutenberg University, Mainz, Germany
Susanne Knake
9 Department of Neurology, Epilepsy Center, University Hospital Marburg, Philipps-University Marburg, Marburg, Germany
Ekaterina Pataraia
13 Department of Neurology, Medical University of Vienna, Vienna, Austria
Thomas Mayer
11 Epilepsy Center Kleinwachau, Radeberg, Germany
Yvonne G Weber
21 Department of Epileptology and Neurology, RWTH Aachen University, Aachen, Germany
Rainer Surges
18 Department of Epileptology, University Hospital Bonn, Bonn, Germany
Jan Wagner
20 Department of Neurology, University of Ulm and Universitäts- und Rehabilitationskliniken Ulm, Ulm, Germany
Hajo M Hamer
5 Epilepsy Center, Department of Neurology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg, Germany, Full member of ERN EpiCARE, Erlangen, Germany
Tim Wehner
22 Ruhr-Epileptology, Department of Neurology, University Hospital Knappschaftskrankenhaus Bochum, Ruhr-University Bochum, Bochum, Germany
Christoph Baumgartner
3 Department of Neurology, Clinic Hietzing, Vienna, Austria
Lukas Imbach
6 Swiss Epilepsy Center, Klinik Lengg, Zurich, Switzerland
Bernhard J Steinhoff
1 Epilepsy Center, Neurocenter, University Medical Center, University of Freiburg, Freiburg, Germany
Sotirios Kalousios
1 Epilepsy Center, Neurocenter, University Medical Center, University of Freiburg, Freiburg, Germany
Jürgen Hesser
2 Mannheim Institute for Intelligent Systems in Medicine, Department of Medicine Mannheim, Interdisciplinary Center for Scientific Computing (IWR), Interdisciplinary Center for Computer Engineering (ZITI), CZS Heidelberg Center for Model-Based AI, Heidelberg University, Heidelberg, Germany
Matthias Dümpelmann
1 Epilepsy Center, Neurocenter, University Medical Center, University of Freiburg, Freiburg, Germany
Elisabeth Kaufmann
7 Epilepsy Center, Department of Neurology, LMU University Hospital, LMU Munich, Munich, Germany
Josua Kegele
8 Department of Neurology and Epileptology, Hertie Institute of Clinical Brain Research, University of Tübingen, Hoppe-Seyler-Straße 3, 72076 Tübingen, Germany
Georg Leonhardt
10 Technische Universität Dresden, Faculty of Medicine and University Hospital Carl Gustav Carus, Department of Neurosurgery, Fetscherstrasse 74, 01307 Dresden, Germany
Carlos M Quesada
16 Department of Neurology and Center for Translational and Behavioral Neurosciences (C-TNBS), University Medicine Essen, Essen, Germany
Berthold R Voges
19 Department of Epileptology, Protestant Hospital Hamburg-Alsterdorf, Elisabeth-Flügge-Str.1, Hamburg, Germany
Introduction A novel focal cortex stimulation (FCS) device has recently received approval in Europe for patients with focal drug-resistant epilepsy (DRE). After 6 months of stimulation, 17 of 32 patients achieved ≥50% reduction in seizure frequency compared with their prestimulation baseline (responders). Currently, there is no established method for predicting FCS treatment response prior to implantation.Methods and analysis This is an ongoing combined retrospective-prospective non-interventional multicentre study. Clinical data of up to 100 patients treated with FCS are collected across 20 collaborating epilepsy centres in four European countries. The key outcome parameters, seizure frequency and severity, are measured along with metrics on cognition, mood and quality of life, both pre-electrode and postelectrode implantation. The data are complemented by demographics, medical history and information on antiseizure medication and FCS treatment parameters during the stimulation period. In addition to clinical data, MRI and electroencephalography registrations are used to gain insights into spatial and electrophysiological aspects of FCS. Multivariate statistical and machine learning analyses are employed to identify key predictive biomarkers associated with patient outcomes (responders vs non-responders). The primary goal is to improve counselling for DRE patients by identifying promising candidates for FCS treatment.Ethics and dissemination This study has received approval from the ethics committee of the University of Freiburg, Germany (23–1540 S1; 23–1183_1-S1-retro). The same approval is applicable for all participating centres in Germany as part of a multicentre study. Ghent University Hospital, Belgium, has received approval for participation in the retrospective arm from their local ethics committee (ONZ-2024-0168). The final approvals for the participating Swiss and Austrian sites are still pending. The results will be made available to the public through peer-reviewed journals and conference presentations.
