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.
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
97
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
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.
Time frame: 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
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
Description of 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.
Description of characteristics and demographics of subjects at the time of implantation of VNS Therapy.
Time frame: Implant procedure
Change of AED treatments
Assess the change in anti-epileptic drugs including dose change
Time frame: 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.
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
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Oxford University Hospital NHSFT
Oxford, United Kingdom
Change in Seizure frequency
Change in Seizure frequency (by seizure type\*, if available) and any changes in 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.
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