EpilepsyDANTENCT04779814
Non-interventional Study Describing Healthcare Resource Utilisation and Clinical Outcomes Associated With VNS Therapy in UK.
An observational study of Epilepsy, run by LivaNova at 5 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Epilepsy
- How many people
- 97 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 11 May 2021to 19 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Subjects whose medical records are not available for review.
- Deceased subjects.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Queen Elizabeth Hospital Birmingham
Birmingham
Bristol Royal Hospital For Children
Bristol
The Walton Centre
Liverpool
Nottingham Children's Hospital
Nottingham
Oxford University Hospital NHSFT
Oxford
About this study
Official title: 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.
Read the 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
- Conditions
- Epilepsy
- Keywords
- VNS, DRE, drug resistant epilepsy, Vagus Nervus Stimulation, Healthcare Resource Utilization
- Medical subject headings
- Epilepsy, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Onset and current classification and any prior classification of seizures will be described using ILAE classification
Measured: 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
Measured: 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.
Measured: Implant procedure
Change of AED treatments
Assess the change in anti-epileptic drugs including dose change
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start11 May 2021
- Primary completion19 Aug 2025
- Study completion19 Aug 2025
Why it stopped: The study was terminated by the sponsor due to persistent delays in recruitment and data availability, including access to the healthcare resource utilization database, which made it difficult to generate meaningful outcomes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OPEN VIE Limited
- Responsible party
- Sponsor
- Investigators
- Mike Carter, Principal investigator, Bristol Royal Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779814
- Sponsor's protocol ID
- LNE801
- Acronym
- DANTE
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2021
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study Describing the Healthcare Resource Utilisation and Clinical Outcomes Associated With LivaNova Vagus Nerve Stimulation Therapy in the UK.
- ClinicalTrials.gov ID
- NCT04779814
- Acronym / sponsor ID
- DANTE / LNE801
- Conditions
- Epilepsy
- Keywords
- VNS, DRE, drug resistant epilepsy, Vagus Nervus Stimulation, Healthcare Resource Utilization
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated by the sponsor due to persistent delays in recruitment and data availability, including access to the healthcare resource utilization database, which made it difficult to generate meaningful outcomes.
- Enrolment
- 97 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Collaborators
- OPEN VIE Limited
- Study start
- 11 May 2021 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- Subjects whose medical records are not available for review.
- Deceased subjects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
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
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.
Time frame: Implant procedure
Change of AED treatments
Time frame: Change from 12-month pre- implantation of VNS device to 18-month post-implantation of VNS device
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 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.
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
Results and safety
The study was stopped early (reason given: The study was terminated by the sponsor due to persistent delays in recruitment and data availability, including access to the healthcare resource utilization database, which made it difficult to generate meaningful outcomes.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Carter principal investigator
Bristol Royal Hospital for Children
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by LivaNova at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated by the sponsor due to persistent delays in recruitment and data availability, including access to the healthcare resource utilization database, which made it difficult to generate meaningful outcomes.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hospital resource utilization (time frame: 12-month pre- implantation of VNS device to 18-month post-implantation of VNS device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.