A prospective, multicenter study of cardiac-based seizure detection to activate vagus nerve stimulation

Boon P, Vonck K, Van Rijckevorsel K, El Tahry R, Elger CE, Mullatti N, Schulze-Bonhage A, Wagner L, Diehl B, Hamer H, Reuber M, Kostov H, Legros B, Noachtar S, Weber YG, Coenen VA, Rooijakkers H, Schijns OEMG, Selway R, Van Roost D, Eggleston KS, Van Grunderbeek W, Jayewardene AK, Mcguire RM (2015)

Publication Type: Journal article

Publication year: 2015

Journal

Seizure-European Journal of Epilepsy Elsevier

Book Volume: 32

Pages Range: 52-61

DOI: 10.1016/j.seizure.2015.08.011

Abstract

This study investigates the performance of a cardiac-based seizure detection algorithm (CBSDA) that automatically triggers VNS (NCT01325623).Thirty-one patients with drug resistant epilepsy were evaluated in an epilepsy monitoring unit (EMU) to assess algorithm performance and near-term clinical benefit. Long-term efficacy and safety were evaluated with combined open and closed-loop VNS.Sixty-six seizures (n=16 patients) were available from the EMU for analysis. In 37 seizures (n=14 patients) a >=20% heart rate increase was found and 11 (n=5 patients) were associated with ictal tachycardia (iTC, 55% or 35bpm heart rate increase, minimum of 100bpm). Multiple CBSDA settings achieved a sensitivity of >=80%. False positives ranged from 0.5 to 7.2/h. 27/66 seizures were stimulated within ±2min of seizure onset. In 10/17 of these seizures, where triggered VNS overlapped with ongoing seizure activity, seizure activity stopped during stimulation. Physician-scored seizure severity (NHS3-scale) showed significant improvement for complex partial seizures (CPS) at EMU discharge and through 12 months (p<0.05). Patient-scored seizure severity (total SSQ score) showed significant improvement at 3 and 6 months. Quality of life (total QOLIE-31-P score) showed significant improvement at 12 months. The responder rate (>=50% reduction in seizure frequency) at 12 months was 29.6% (n=8/27). Safety profiles were comparable to prior VNS trials.The investigated CBSDA has a high sensitivity and an acceptable specificity for triggering VNS. Despite the moderate effects on seizure frequency, combined open- and closed-loop VNS may provide valuable improvements in seizure severity and QOL in refractory epilepsy patients.

Authors with CRIS profile

Hajo Hamer Professur für Epileptologie

Involved external institutions

Eberhard Karls Universität Tübingen DE Germany (DE) Universitätsklinikum Freiburg DE Germany (DE) Université Catholique de Louvain (UCL) BE Belgium (BE) Kempenhaeghe NL Netherlands (NL) King's College Hospital (KCH) GB United Kingdom (GB) University Hospital Ghent BE Belgium (BE) Cyberonics Inc US United States (USA) (US) Universitätsklinikum Bonn DE Germany (DE) Cliniques universitaires Saint-Luc (CHU St-Luc) BE Belgium (BE) University College London Hospitals (UCLH) GB United Kingdom (GB) University of Sheffield GB United Kingdom (GB) Oslo University Hospital / Oslo Universitetssykehus Rikshospitalet NO Norway (NO) Université libre de Bruxelles (ULB) / Free University of Brussels BE Belgium (BE) Ludwig-Maximilians-Universität (LMU) DE Germany (DE)

How to cite

APA:

Boon, P., Vonck, K., Van Rijckevorsel, K., El Tahry, R., Elger, C.E., Mullatti, N.,... Mcguire, R.M. (2015). A prospective, multicenter study of cardiac-based seizure detection to activate vagus nerve stimulation. Seizure-European Journal of Epilepsy, 32, 52-61. https://dx.doi.org/10.1016/j.seizure.2015.08.011

MLA:

Boon, Paul, et al. "A prospective, multicenter study of cardiac-based seizure detection to activate vagus nerve stimulation." Seizure-European Journal of Epilepsy 32 (2015): 52-61.

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