The long-term effect of vagus nerve stimulation on quality of life in patients with pharmacoresistant focal epilepsy: the PuLsE (Open Prospective Randomized Long-term Effectiveness) trial

Journal article


Publication Details

Author(s): Ryvlin P, Gilliam FG, Nguyen DK, Colicchio G, Iudice A, Tinuper P, Zamponi N, Aguglia U, Wagner L, Minotti L, Stefan H, Boon P, Sadler M, Benna P, Raman P, Perucca E
Journal: Epilepsia
Publisher: Wiley-Blackwell
Publication year: 2014
Volume: 55
Journal issue: 6
Pages range: 893-900
ISSN: 0013-9580


Abstract


To evaluate whether vagus nerve stimulation (VNS) as adjunct to best medical practice (VNS + BMP) is superior to BMP alone in improving long-term health-related quality of life (HRQoL).PuLsE (Open Prospective Randomized Long-term Effectiveness) was a prospective, randomized, parallel-group, open-label, and long-term effectiveness study (conducted at 28 sites in Europe and Canada). Adults with pharmacoresistant focal seizures (n = 112) received VNS + BMP or BMP (1:1 ratio). Medications and VNS parameters could be adjusted as clinically indicated for optimal seizure control while minimizing adverse effects. Primary endpoint was mean change from baseline HRQoL (using Quality of Life in Epilepsy Inventory-89 total score; QOLIE-89). Secondary endpoints included changes in seizure frequency, responder rate (>=50% decrease in seizure frequency), Centre for Epidemiologic Studies Depression scale (CES-D), Neurological Disorders Depression Inventory-Epilepsy scale (NDDI-E), Clinical Global Impression-Improvement scale (CGI-I), Adverse Event Profile (AEP), and antiepileptic drug (AED) load. The study was prematurely terminated due to recruitment difficulties prior to completing the planned enrollment of n = 362. Results for n = 96 who had baseline and at least one follow-up QOLIE-89 assessment (from months 3-12) were included in this analysis. Mixed model repeated measures (MMRM) analysis of variance was performed on change from baseline for the primary and secondary endpoints.Significant between-group differences in favor of VNS + BMP were observed regarding improvement in HRQoL, seizure frequency, and CGI-I score (respective p-values < 0.05, 0.03, and 0.01). More patients in the VNS + BMP group (43%) reported adverse events (AEs) versus BMP group (21%) (p = 0.01), a difference reflecting primarily mostly transient AEs related to VNS implantation or stimulation. No significant difference between treatment groups was observed for changes in CES-D, NDDI-E, AEP, and AED load.VNS therapy as a treatment adjunct to BMP in patients with pharmacoresistant focal seizures was associated with a significant improvement in HRQoL compared with BMP alone. A PowerPoint slide summarizing this article is available for download in the Supporting Information section here.



FAU Authors / FAU Editors

Stefan, Hermann Prof. Dr.
Medizinische Fakultät


External institutions with authors

Catholic University of the Sacred Heart / Università Cattolica del Sacro Cuore
Cyberonics Inc
Dalhousie University
Grenoble University Hospital Centre / Centre Hospitalier Universitaire de Grenoble (CHUG)
Kempenhaeghe
Magna Græcia University of Catanzaro / Università degli studi Magna Græcia di Catanzaro
National Center for Scientific Research / Centre national de la recherche scientifique (CNRS)
Pennsylvania State University (Penn State)
Università degli Studi di Pavia
Université de Montréal
Universiteit Gent (UGent) / Ghent University
University of Bologna / Università di Bologna
University of Pisa / Università di Pisa (UniPi)
University of Turin / Università degli Studi di Torino (UNITO)


How to cite

APA:
Ryvlin, P., Gilliam, F.G., Nguyen, D.K., Colicchio, G., Iudice, A., Tinuper, P.,... Perucca, E. (2014). The long-term effect of vagus nerve stimulation on quality of life in patients with pharmacoresistant focal epilepsy: the PuLsE (Open Prospective Randomized Long-term Effectiveness) trial. Epilepsia, 55(6), 893-900. https://dx.doi.org/10.1111/epi.12611

MLA:
Ryvlin, Philippe, et al. "The long-term effect of vagus nerve stimulation on quality of life in patients with pharmacoresistant focal epilepsy: the PuLsE (Open Prospective Randomized Long-term Effectiveness) trial." Epilepsia 55.6 (2014): 893-900.

BibTeX: 

Last updated on 2018-08-10 at 08:31