CORE-VNS
Research type
Research Study
Full title
Comprehensive Outcomes Registry in Subjects with Epilepsy Treated with Vagus Nerve Stimulation Therapy®
IRAS ID
242687
Contact name
Jason Jones
Contact email
Sponsor organisation
LivaNova Inc USA
Clinicaltrials.gov Identifier
Duration of Study in the UK
8 years, 8 months, 7 days
Research summary
Research Summary:
Vagus Nerve Stimulation (VNS) Therapy has been CE Marked for the treatment of epilepsy non-responding to the pharmacological traetment since 1994 and FDA approved since 1997. This post-market observational registry is designed to collect data on the standard of care clinical course and outcomes for patients with refractory seizures treated with adjunctive VNS Therapy.
Outcomes related to seizure severity and frequency, safety, quality of life, sleep and healthcare utilization will be documented and evaluated. The results of this study will provide data to guide physicians, the patients and the company in the use of VNS Therapy.Summary of results:
The results of this study indicate that VNS Therapy is both safe and effective, leading to improvements in seizure frequency, severity, post-ictal severity, and quality of life, as well as reductions in healthcare resource utilization. No worsening in sleep quality was observed. Subgroup analyses showed that the early use of VNS Therapy (by age, by epilepsy years, and by ASMs) can significantly impact the degree of focal seizure reduction while the robust reduction of generalized seizures associated with VNS Therapy does not display the same time-dependent impact. VNS Therapy remains the least invasive surgical intervention in epilepsy. VNS Therapy remains the least invasive surgical intervention for drug-resistant epilepsy, with an excellent safety profile.
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REC name
London - Harrow Research Ethics Committee
REC reference
18/LO/0552
Date of REC Opinion
27 Jun 2018
REC opinion
Further Information Favourable Opinion