An interventional study of Vagus nerve stimulation in Refractory Epilepsy, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Other
A VNS longitudinal study focused on pre and post-VNS implantation in order to predict the VNS response and to understand better mechanisms of VNS using some connectivity and network measures.
275 studies on the registry are indexed under Drug Resistant Epilepsy; 104 are open to participants now.
This study's planned enrollment of 20 is below the median of 30 across 217 interventional studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 349 studies on the registry; 63 are open to participants now.
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Exclusion Criteria:
We will compare responders with non-responders to VNS, but both are part of the implanted arm.
Device: Vagus nerve stimulation
No intervention was performed for the study, since VNS is already part of the treatment of these patients. However, VNS parameters are changed for the sake of the study and reestablished at the end.
Pupillometry
Using an eye-tracking camera, we will record pupil dilation responses (PDR) induced by both VNS and an oddball paradigm. The PDR signals (measured in arbitrary units and converted to mm) will be aligned with the corresponding stimulus in order to extract the trials. From these, classical PDR metrics such as peak amplitude or latency can be derived.
Time frame: Before Implantation, 3 Months, and 6 Months Post Implantation
P300
The P300 component of the evoked potential can be extracted from electroencephalography (EEG) signals as a wave peaking around 300 ms after a given stimulus. An auditory oddball paradigm will be employed as the stimulus. Then, we derive classical metrics from the P300, such as amplitude and latency.
Time frame: Before Implantation, 3 Months, and 6 Months Post Implantation
LMEP
We aim to record a reproducible and quantifiable VNS-induced laryngeal motor-evoked potential (LMEP) from the electromyography (EMG) signal at the larynx level. After filtering the signal, the relevant component that is expected to be observed consists of the artefacts generated by the ON periods of the VNS - each VNS pulse will contain a laryngeal response, which appears right after the VNS pulse. With this laryngeal response detected, the LMEP will be characterised by quantitative features including peak amplitude (μV) and latency (ms).
Time frame: Before Implantation, 3 Months, and 6 Months Post Implantation
Response assessment
At 6 months, we will evaluate the seizure frequency reduction compared to 3 months before implantation.
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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