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

March 20, 2026 updated by: LivaNova

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in hospital resource utilization
Time Frame: 12-month pre- implantation of VNS device to 18-month post-implantation of VNS device
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of AED treatments
Time Frame: Change from 12-month pre- implantation of VNS device to 18-month post-implantation of VNS device
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
Time Frame: 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device
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
Time Frame: 18-month period post-implantation of 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.
Time Frame: Implant procedure
Description of characteristics and demographics of subjects at the time of implantation of VNS Therapy.
Implant procedure
Change in Seizure severity
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 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
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 (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.
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 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LivaNova

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
OPEN VIE Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mike Carter, Bristol Royal Hospital for Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 19, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 19, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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