Non-interventional Study Describing Healthcare Resource Utilisation and Clinical Outcomes Associated With VNS Therapy in UK. (DANTE)

A Non-interventional Study Describing the Healthcare Resource Utilisation and Clinical Outcomes Associated With LivaNova Vagus Nerve Stimulation Therapy in the UK.

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.

Study Overview

• Status: Terminated
• Conditions: Epilepsy

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

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
    • Queen Elizabeth Hospital Birmingham
  • Bristol, United Kingdom
    • Bristol Royal Hospital for Children
  • Liverpool, United Kingdom
    • The Walton Centre
  • Nottingham, United Kingdom
    • Nottingham Children's Hospital
  • Oxford, United Kingdom
    • Oxford University Hospital NHSFT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
Cohort 1; Demipulse®/Aspire HC® (30 adult subjects)
Cohort 2; Demipulse®/Aspire HC® (30 pediatric subjects)
Cohort 3; Aspire SR® (30 adult subjects)
Cohort 4; Aspire SR® (30 pediatric subjects)
Cohort 5; SenTiva® (30 adult subjects)
Cohort 6; SenTiva® (30 pediatric subjects)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12-month pre- implantation of VNS device to 18-month post-implantation of VNS device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of AED treatments	Assess the change in anti-epileptic drugs including dose change	Change from 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	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	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.	Implant procedure
Change in Seizure severity	Change in Seizure severity; using measures such as rescue medication and/or time to recovery.	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.	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.	Change from 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device

Collaborators and Investigators

• Sponsor: LivaNova
• Collaborators: OPEN VIE Limited
• Investigators: Principal Investigator: Mike Carter, Bristol Royal Hospital for Children

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Actual): August 19, 2025
• Study Completion (Actual): August 19, 2025

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: VNS; drug resistant epilepsy; DRE; Vagus Nervus Stimulation; Healthcare Resource Utilization
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Drug Resistant Epilepsy; Epilepsy
• Other Study ID Numbers: LNE801

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No