QUality of life and Economic evaluation after neuroSTimulation for Epilepsy (QUESTE) in adolescents and adults with drug-resistant epilepsy: protocol for a multicentre, prospective observational cohort study in The Netherlands
Linda Ackermans,
Sander van Kuijk,
Ghislaine A P G van Mastrigt,
Kim Rijkers,
Anne-Marthe Meppelink,
Jacco J A S Smeets,
Olaf Schijns,
Rob Rouhl,
G Louis Wagner,
Jeske Nelissen,
Ilse E C W van Straaten,
Kuan Kho,
Francesca Snoeijen-Schouwenaars,
Sylvia Klinkenberg,
H J M Majoie
Affiliations
Linda Ackermans
Department of Psychiatry and Neuropsychology, Maastricht University School for Mental Health and Neuroscience, Maastricht, The Netherlands
Sander van Kuijk
Clinical Epidemiology and Medical Technology Assessment, Maastricht Universitair Medisch Centrum+, Maastricht, The Netherlands
Ghislaine A P G van Mastrigt
2 Department of Health Services Research, Maastricht University, Maastricht, The Netherlands
Kim Rijkers
1 Department of Neurosurgery, Maastricht University Medical Centre+, Maastricht, The Netherlands
Anne-Marthe Meppelink
SEIN: Centre of Excellence for Epilepsy and Sleep Medicine, Zwolle, UK
Jacco J A S Smeets
Department of Neurosurgery, Maastricht University Medical Centre+, Maastricht, The Netherlands
Olaf Schijns
Department of Psychiatry and Neuropsychology, Maastricht University School for Mental Health and Neuroscience, Maastricht, The Netherlands
Rob Rouhl
Department of Neurology, Maastricht University Medical Centre+, Maastricht, The Netherlands
G Louis Wagner
Maastricht University School for Mental Health and Neuroscience, Maastricht, The Netherlands
Jeske Nelissen
Department of Neurology, Maastricht University Medical Centre+, Maastricht, The Netherlands
Ilse E C W van Straaten
8 Department of Neurology, Amsterdam UMC VUMC Site, Amsterdam, The Netherlands
Kuan Kho
Department of Neurosurgery, Medisch Spectrum Twente, Enschede, The Netherlands
Francesca Snoeijen-Schouwenaars
Department of Neurology, Academic Centre for Epileptology, Epilepsy Centre Kempenhaeghe & Maastricht University Medical Centre+, Heeze, The Netherlands
Sylvia Klinkenberg
Department of Neurology, Maastricht University Medical Centre+, Maastricht, The Netherlands
H J M Majoie
Maastricht University School for Mental Health and Neuroscience, Maastricht, The Netherlands
Introduction Epilepsy is one of the most common chronic neurological disorders. Antiseizure medication (ASM) is the first choice of treatment, however, 30% of epilepsy patients are drug-resistant. For these patients, neuromodulation can be an option, especially when epilepsy surgery is not possible or did not lead to seizure freedom. Epilepsy is associated with reduced quality of life (QoL), which heavily depends on seizure control.The most recent Cochrane reviews have shown that vagus nerve stimulation and deep brain stimulation of the anterior nucleus of the thalamus, lead to a responder rate OR of, respectively, 1.93 and 1.20. The question arises if neuromodulation for drug-resistant epilepsy (DRE) will be more cost-effective than sole treatment with ASM. The current study aims to determine the change in QoL after neuromodulation. Secondarily, we will aim to study the cost-effectiveness of these treatments.Methods and analysis This prospective cohort study aims at including 100 patients aged 16 or above who will be referred for neuromodulation, from January 2021 to January 2026. After informed consent, QoL and other relevant parameters will be assessed at baseline, 6 months, 1, 2 and 5 years after surgery. Data on seizure frequency will be derived from patient charts. We expect that DRE patients will report better QoL after neuromodulation. Even if they would still report seizures, the treatment can be seen as useful. This is especially true when patients can participate in society again to a greater extent than before treatment.Ethics and dissemination The board of directors of participating centres all gave permission for this study to commence. The medical ethics committees decided that this study does not fall under the Medical Research Involving Human Subjects Act (WMO). The findings of this study will be presented at (inter)national conferences and in peer-reviewed journals.Trial registration number NL9033.
