Clinical trial NCT04779814: Non-interventional Study Describing Healthcare Resource Utilisation and Clinical Outcomes Associated With VNS Therapy in UK.
Official title: A Non-interventional Study Describing the Healthcare Resource Utilisation and Clinical Outcomes Associated With LivaNova Vagus Nerve Stimulation Therapy in the UK.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Epilepsy
Keywords: VNS
DRE
drug resistant epilepsy
Vagus Nervus Stimulation
Healthcare Resource Utilization
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
Collaborators: name: OPEN VIE Limited
First posted: 2021-03-03
Enrollment: 97
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

Living subjects who meet all of the following criteria will be considered for enrolment:

* Clinical diagnosis of drug resistant epilepsy
* Subjects who have had their first VNS device (Demipulse®/Aspire HC®, Aspire SR® and SenTiva®) implanted at least 18 months prior to their enrolment in the study data (with no change in generator, battery or lead).
* For SenTiva® and Aspire SR®, AutoStim was first activated within 1 month of implantation.
* For SenTiva®, scheduled dosing mode was activated within 1 month of implantation.
* Subjects must be able and willing to provide informed consent; subjects aged 7-12 years old and 13-15 years old will be provided with appropriate information and consent forms to explain the study in age appropriate language. These subjects will be asked to provide their assent to take part in the study, with consent provided by their parent/carer. Subjects under 7 years will be included in the study with consent from their parent/carer. For adult subjects (≥16 years) lacking the mental capacity to consent, advice about participation will be sought from an appropriate consultee, according to the Mental Capacity Act 2005.
* Adult and paediatric subjects (aged over 2.5 years at study enrolment) with available medical records for at least 12 months prior to VNS device implantation.

Exclusion Criteria:

* Subjects whose medical records are not available for review.
* Deceased subjects.

Primary outcomes:
measure: Change in hospital resource utilization
timeFrame: 12-month pre- implantation of VNS device to 18-month post-implantation of VNS device
Secondary outcomes:
measure: Change in Seizure information using ILAE classification
timeFrame: 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device
measure: Initial titration period for each VNS device
timeFrame: 18-month period post-implantation of VNS device.
measure: Characteristics and demographics of subjects at the time of implantation of VNS Therapy.
timeFrame: Implant procedure
measure: Change of AED treatments
timeFrame: Change from 12-month pre- implantation of VNS device to 18-month post-implantation of VNS device
measure: Change in Seizure severity
timeFrame: Change from 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device
measure: Change in Seizure frequency
timeFrame: Change from 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device
measure: Change in frequency of status epilepticus.
timeFrame: Change from 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital For Children
city: Liverpool
country: United Kingdom
facility: The Walton Centre
city: Nottingham
country: United Kingdom
facility: Nottingham Children's Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospital NHSFT
Study officials:
affiliation: Bristol Royal Hospital for Children
name: Mike Carter
role: PRINCIPAL_INVESTIGATOR
References: