An observational study in Epilepsy, sponsored by LivaNova. Terminated at 5 sites in United Kingdom. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by LivaNova · Observational
This is a UK, multi-center, non-interventional study based on the use of health service administrative and medical records (paper-based and/or electronic, as applicable) along with the use of prospectively collected subject-reported outcomes on experience with use of VNS therapy using validated and bespoke self-completion questionnaires. Data for hospital resource utilisation will be extracted from the Hospital Episode Statistics (HES) database.
Failure to control seizures in subjects with treatment resistant epilepsy can have a significant burden on the healthcare system. Vagus Nerve Stimulation (VNS) is an adjunctive treatment for patients with drug resistant epilepsy and is reported to reduce the frequency of seizures in adults and children. However, real-world data on healthcare resource utilization by patients with treatment-resistant epilepsy and their clinical outcomes prior to and post VNS device implantation in the UK are limited. The current study aims to describe the resource utilization and clinical outcomes prior to and following the implantation of different VNS devices (Demipulse®/Aspire HC®, Aspire SR® and SenTiva®) in subjects with drug resistant epilepsy
Male and female adult (aged ≥16 years at VNS implantation) and paediatric (aged 1-15 years at VNS implantation) subjects with epilepsy who have had a VNS device Demipulse®/Aspire HC®, Aspire SR® or SenTiva® implanted will be involved in this study.
Living subjects who meet all of the following criteria will be considered for enrolment:
Exclusion Criteria:
Demipulse®/Aspire HC® (30 adult subjects)
Demipulse®/Aspire HC® (30 pediatric subjects)
Aspire SR® (30 adult subjects)
Aspire SR® (30 pediatric subjects)
SenTiva® (30 adult subjects)
SenTiva® (30 pediatric subjects)
Change in hospital resource utilization
Description of change in hospital resource utilization from the 12-month period pre- to the 18-month period post-implantation of VNS device in subjects with drug resistant epilepsy.
Time frame: 12-month pre- implantation of VNS device to 18-month post-implantation of VNS device
Change in Seizure information using ILAE classification
Onset and current classification and any prior classification of seizures will be described using ILAE classification
Time frame: 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device
Initial titration period for each VNS device
Description of initial titration period for each VNS device
Time frame: 18-month period post-implantation of VNS device.
Characteristics and demographics of subjects at the time of implantation of VNS Therapy.
Description of characteristics and demographics of subjects at the time of implantation of VNS Therapy.
Time frame: Implant procedure
Change of AED treatments
Assess the change in anti-epileptic drugs including dose change
Time frame: Change from 12-month pre- implantation of VNS device to 18-month post-implantation of VNS device
Change in Seizure severity
Change in Seizure severity; using measures such as rescue medication and/or time to recovery.
Time frame: Change from 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device
Change in Seizure frequency
Change in Seizure frequency (by seizure type\*, if available) and any changes in frequency.
Time frame: Change from 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device
Change in frequency of status epilepticus.
Change in frequency of status epilepticus.
Time frame: Change from 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device
This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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