Patients treated with NeuroPace’s Responsive Neurostimulation system within 20 years of epilepsy onset were observed to have significantly better outcomes related to several aspects of quality of life and mood compared to those treated later.
David W. Loring, PhD
New data from a poster presentation at the 73rd annual meeting of the American Epilepsy Society (AES), December 6-10, 2019, in Baltimore, Maryland, has revealed findings that suggest that patients with epilepsy who are treated with responsive neurostimulation earlier in their disease course are more likely to have improvements in mood and quality of life.1
The study, led by David W. Loring, PhD, professor of neurology and pediatrics, and director, neuropsychology, Emory University School of Medicine, included more than 140 patients. It compared those who were treated early—defined as within 20 years of epilepsy onset—with those who were treated late—defined as after 20 years from the onset—with NeuroPace’s Responsive Neurostimulation (RNS) system. The system was granted regulatory approval in 2013.
“These results suggest that early intervention maximizes the opportunity for improvements in mood and quality of life; if treatment is delayed for too long, improvements in mood and quality of life may no longer be possible,” Loring and colleagues wrote.
Patients were evaluated at 3-month pretreatment (baseline), at year 2 for mood—done with the Beck Depression Inventory-II (BDI)—and year 8 for quality of life—assessed using the Quality of Life in Epilepsy Inventory (QOLIE-89) overall score and the derived epilepsy-targeted, cognitive, mental, and physical subscales.
Ultimately, for those who had completed the QOLIE-89 at both time points, the rate of seizure reduction was observed to be similar between the 2 groups. Those in the early treatment group (n = 67) experienced a median reduction of 70% (interquartile range [IQR], 62.7) across the 8-year study period, compared to 73.3% (IQR, 44.6) in the late treatment group (n = 76). Similarly, those who had completed the mood assessment at both time points in the early treatment group (n = 73) experienced a median seizure rate reduction of 53.9% (IQR, 71.1) across those 2 years, compared to a 55.0% (IQR, 60.3) reduction in the late-treatment group (n = 70).
Despite the similar rates of seizure reduction, quality of life and mood improvements were significantly different. Those in the early treatment group experienced markedly better improvements for their overall quality of life score (P <.05), as well as on the physical (P <.01), mental (P <.05), and cognitive (P <.05) subscales. The epilepsy-targeted domain, however, suggested similar improvements in both groups. On the BDI, those who were treated early also experienced significantly different improvements (P <.05).
When comparing the improvement for each group from baseline, the early-treatment patients had significant improvements in mood (P <.01), overall quality of life (P <.01), and the quality of life physical (P <.05), cognitive (P <.001), and epilepsy-targeted (P <.0001) subscales. Their improvement on the mental subdomain was not significant.
“In contrast, patients in the late-treatment group had no significant improvements in mood nor any aspect of quality of life, other than the epilepsy-targeted domain,” Loring and colleagues noted.
While on-site at AES 2019, NeurologyLive was told by Aimee W. Smith, PhD, assistant professor of psychology, East Carolina University, who focuses much of her practice and research on improving patient adherence and quality of life, that quality of life can often fall to the wayside in epilepsy treatment as treatment plans must focus so sharply on seizure reduction.
Smith describes quality of life as “the patient’s perspective of how things are going generally in the context of their lives,” including their social experiences and challenges in daily activities.
“When we think about addressing epilepsy, we want to stop their seizures or reduce them as much as we can, and we want to make sure we do that with minimal or no side effects. But a lot of times, we forget about this third piece: quality of life,” she said.
Additional 1-year interim findings of a 5-year, post-approval study presented at AES 2019 suggest that the NeuroPace RNS system is safe and effective in treating medically intractable focal seizures. Those data thus far include 191 adult patients and show a greater reduction of seizures than the initial pivotal trial of the system at the same time point. The median seizure frequency reduction with the neurostimulation device was 68% (IQR, 16.1—96) at 1 year compared to 44% in the pivotal trial. Additionally, the responder rate was 61% (95% CI, 52.3­–69.0) at the end of the first year.2
For more coverage of AES 2019, click here.
1. Loring DW, Jarosiewicz B, Meador KJ, Kanner AM, Skarpaas TC, Morrell MJ. Mood and Quality of Life in Patients Treated With Brian-Responsive Neurostimulation: The Value of Earlier Intervention. Presented at: American Epilepsy Society 2019 Meeting; December 7—10; Baltimore, Maryland. Abstract 1.227.
2. Szaflarski JP, Morrell MJ. Interim Safety and Effectiveness Outcomes from a Prospective Post-Approval Trial of the RNS System. Presented at: American Epilepsy Society 2019 Meeting; December 7—10; Baltimore, Maryland. Abstract 1.228.1