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

NCT04779814 | Terminated

• 1 other identifier: LNE801
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 5

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.

Conditions

Epilepsy

Keywords

VNS; DRE; drug resistant epilepsy; Vagus Nervus Stimulation; Healthcare Resource Utilization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Seizure information 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

  18-month period post-implantation of VNS device.

• Characteristics and demographics of subjects at the time of implantation of VNS Therapy.

  Implant procedure

• Change of AED treatments

  Change from 12-month pre- implantation of VNS device to 18-month post-implantation of VNS device

• Change in Seizure severity

  Change from 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device

Study Arms (6)

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)

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• LivaNova: lead
• OPEN VIE Limited: collaborator

Study Sites (5)

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom

Location

Bristol Royal Hospital For Children

Bristol, United Kingdom

Location

The Walton Centre

Liverpool, United Kingdom

Location

Nottingham Children's Hospital

Nottingham, United Kingdom

Location

Oxford University Hospital NHSFT

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy; Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mike Carter

  Bristol Royal Hospital for Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 3, 2021
• Study Start: May 11, 2021
• Primary Completion: August 19, 2025
• Study Completion: August 19, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

GB (5)