This post-market study involves collecting information for an already approved VNS device to get detailed information about the outcomes of people receiving the approved treatment.
About this study
People participating in this study must be deemed appropriate for VNS treatment by their treating doctors and be planned for surgery at the RMH.
The purpose of this study is to better understand the following areas of health for people who receive VNS treatment:
- Anti-epileptic treatment and medication taken by people who have had a VNS device implanted
- Frequency and severity of seizures
- Quality of life and quality of sleep (reported through questionnaires)
- What types of healthcare services are being used
- Details of the settings used on the VNS device
Anticipated enrolment close date: 2022
Who can take part
- Diagnosis of drug-resistant epilepsy to be treated with vagus nerve stimulation therapy
- Able to attend scheduled (and any required unscheduled) study visits
What's involved
Given the post-market nature of this study, procedures involved are required for routine care - that is, no extra procedures are required
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.
The Clinical Trials Centre (CTC) is a dedicated, purpose-built space where we conduct clinical trials.
The CTC is located on Level 2 South. When you arrive, if you are unsure where to go, talk to one of our friendly volunteers or the information desk staff.