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

Epilepsy Clinical Trial

— DANTE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04779814
• Other study ID #: LNE801
• Status: Active, not recruiting
• Start date: May 11, 2021
• Est. completion date: December 2025

Study information

• Verified date: July 2023
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 self-completion questionnaires. Data for hospital resource utilisation will be extracted from the Hospital Episode Statistics (HES) database.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 97
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital Birmingham	Birmingham
United Kingdom	Bristol Royal Hospital For Children	Bristol
United Kingdom	The Walton Centre	Liverpool
United Kingdom	Nottingham Children's Hospital	Nottingham
United Kingdom	Oxford University Hospital NHSFT	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
LivaNova	OPEN VIE Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Initial titration period for each VNS device	Description of initial titration period for each VNS device	18-month period post-implantation of VNS device.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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