Epilepsy Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People aged 4 to 75 years.
- People who have focal (partial) seizures or generalised seizures that have not been controlled by anti-seizure medications.
- People who have had at least 4 seizures per month on average over the 90 days before enrolling.
- People diagnosed with Drug Resistant Epilepsy, meaning seizures have not been controlled despite trying two or more appropriate anti-seizure medications.
- People whose anti-seizure medications have been at a stable, consistent dose for at least 30 days before enrolling, and who are able to keep that dose stable through the first 6 months after the device is activated (emergency rescue medications may still be used when needed).
Who may not be able to join:
- People who are not suitable for the surgery required to implant the iVEAcare Neuromodulation System.
- People with a worsening neurological condition or another deteriorating medical condition.
- People who have previously had their left vagus nerve surgically cut.
- People who currently require diathermy treatment anywhere in their body (including short-wave, microwave, or therapeutic ultrasound diathermy).
- People with known damage to the vagus nerve, or other reasons why the left vagus nerve would not be suitable for the implant.
- People with paralysis of the vocal cords.
- People who have had brain surgery for epilepsy within 6 months before the baseline study visit.
- People who already have certain implanted or external electrical devices, including a cardiac defibrillator, pacemaker, deep brain stimulator, responsive neurostimulator, spinal cord stimulator, peripheral nerve stimulator, sacral nerve stimulator, carotid baroreceptor stimulator, cochlear implant, or an external nerve stimulation device such as a TENS machine. Note: People who already have an approved vagus nerve stimulation (VNS) system for drug-resistant epilepsy and whose device is nearing end of life may be considered for a generator replacement only — confirm with the trial site for details.
- People who are pregnant or planning to become pregnant within the next 12 months.
- People with any currently active cancer, not including skin cancer.
- People with an active infection near the implant site or anywhere in the body.
- People with poorly controlled Type 1 or Type 2 diabetes, as measured by a specific blood sugar level marker (HbA1c above a certain threshold) — confirm the exact threshold with the trial site.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Terence O'Brien, MD, The Alfred Hospital and Monash University
Phone: +1 651 728 4832
Australian sites
07 3163 2850
+61 3 9076 2029
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
iVEAcare Neuromodulation System Safety
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.