A new system of vagus nerve stimulation (VNS) therapy was implanted in the first patient with drug-resistant epilepsy, as part of a global registry launched by LivaNova to evaluate the treatment in a real-world setting.
The CORE-VNS registry (NCT03529045) plans to include up to 2,000 patients with drug-resistant epilepsy to be treated with any approved VNS therapy. It will gather five years of follow-up data in up to 80 sites globally, representing one of the largest data sets in the world for drug-resistant epilepsy patients treated with VNS therapy. Patient recruitment is ongoing.
CORE-VNS will assess the VNS therapy’s safety, effectiveness, and clinical outcomes, such as seizure frequency and severity, quality of life, sleep quality, anti-epileptic therapy use, as well as seizure-related emergency department visits and hospitalizations.
The first implanted patient received LiveNova’s latest pulse generator in VNS therapy, called SenTiva, and was enrolled at Pediatric Epilepsy & Neurology Specialists in Tampa, Florida. Another patient, enrolled at Oxford University Hospitals NHS Foundation Trust in the U.K., is expected to be implanted soon.
“Many patients with drug-resistant epilepsy have tried numerous treatment options with limited results. The CORE-VNS study will give us a greater understanding of the drug-resistant epilepsy patient population around the world and the role VNS Therapy can play in the overall management of this disease,” Bryan Olin, LivaNova’s senior vice president of clinical, quality assurance and regulatory affairs, said in a press release.
Olin added that the study will enable the evaluation of the latest developments in VNS therapy, “including the capability to track and use real-time patient data to inform treatment.”
“By following these patients for five years, we will gain a significant amount of high-quality, real-world clinical data on VNS Therapy as an adjunctive treatment for drug-resistant epilepsy,” said Kore Liow, MD, from the Comprehensive Epilepsy Center at Hawaii Pacific Neuroscience, who has enrolled the most patients to date in the CORE-VNS registry.
VNS therapy is an approved treatment for Dravet syndrome patients. Research has shown that this treatment strategy is able to decrease seizure frequency and improve speech development in children with Dravet syndrome, with no unwanted cognitive side effects.
The VNS system consists of a programmable electronic pulse generator connected to an electrical lead, which stimulates the vagus nerve at regular intervals throughout the day. Both components are implantable. Stimulation with VNS is believed to ease the overactive signaling in the brain that causes seizures.
The vagus nerve is the longest nerve in the autonomic nervous system — which controls internal organs and glands — extending from the head to the abdomen. It has sensory and motor functions, and innervates organs such as the pharynx, larynx, heart, esophagus, stomach, and bowel.
VNS therapy received a CE mark — a European certification indicating conformity with health, safety, and environmental protection standards — in 1994 and was approved by the U.S. Food and Drug Administration in 1997 as an add-on treatment for drug-resistant epilepsy.