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
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.
Epilepsia, 55(6):893–900, 2014
https://doi.org/doi: 10.1111/epi.12611
This open Prospective #randomized Long-term Effectiveness (PuLsE) study by Ryvlin et al., 2014, examined changes in health related quality of life (#HRQoL) following vagus nerve stimulation (#VNS) implantation in patients with drug resistant epilepsy (#DRE).
Highlights
• Patients treated with VNS Therapy achieved significantly larger improvements in HRQoL.
• The responder rate (≥50% reduction in #seizure frequency) for patients treated with VNS Therapy, in combination with best medical practice (#BMP), was comparable to that of BMP alone.
• No significant differences in the progression of depressive #mood was observed between the two groups.
Following an eight-week long baseline period, patients were randomized into two different treatment groups (1. VNS Therapy in combination with BMP, n=48, or 2. BMP alone, n=48) for a duration of up to 24 months. The study’s primary endpoint was change from baseline in HRQoL, measured by the Quality of Life in Epilepsy Inventory-89 questionnaire (#QOLIE-89). Secondary outcomes incorporate the analysis of characteristics such as responder rate, seizure frequency reduction, and possible effects on depressive mood.
Unfortunately, the study was terminated prematurely due to recruitment issues. Nevertheless, of the 96 patients analyzed, the VNS Therapy group experienced significantly larger improvements in HRQoL compared to BMP alone at the 12-month follow-up (mean improvement: 5.5±7.2 and 1.2±6.9, respectively). However, no significant alterations in depressive mood over time (as measured by the Centre for Epidemiologic Studies Depression Scale, #CES-D, and the Neurological Disorders Depression Inventory-Epilepsy scale, #NDDI-E) were observed between groups, indicating the improvement in HRQoL to be dependent on other factors then depressive symptoms. Likewise, no significant difference in responder rate could be observed between groups.
Despite the early termination of the study, the current result highlights the valuable beneficial effects of adjunctive VNS Therapy on HRQoL in patients with DRE.
