iVEAcare Neuromodulation System for drug‑resistant epilepsy: a feasibility look

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a feasibility/interventional study investigating the iVEAcare neuromodulation system for people with drug‑resistant epilepsy. All participants will receive the iVEAcare device implant, and researchers will monitor safety related to the procedure and device, as well as changes in seizure frequency, seizure severity, and quality of life after activation. Participants will have follow‑ups at 1 month, 3 months, 6 months, 1 year, 18 months, and then annually up to 5 years. The study analyzes how the device performs in real‑world conditions and whether it provides a meaningful improvement for patients who have not responded to multiple anti‑seizure medications.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Age 4 to 75 years.
* Focal (partial) onset seizures (with or without secondary generalization) or generalized seizures that are refractory to anti-seizure medications.
* A minimum of 4 seizures per month averaged over the 90 days prior to enrollment.
* Participant is diagnosed with Drug Resistant Epilepsy (DRE) - Failure to achieve seizure control with adequate trials of two or more tolerated anti-seizure medications.
* Anti-seizure medications must be at a steady state for a minimum of 30 days and remain stable through the 6-month post-activation study visit. Rescue medications may still be used as necessary

Key Exclusion Criteria:

* Unsuitable for iVEAcare Neuromodulation System implant surgery.
* Deteriorating neurologic or other deteriorating medical conditions.
* Previous left vagotomy (left vagus nerve cut to treat another disorder).
* A condition currently requiring diathermy treatment anywhere in their body (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy).
* Known vagal neuropathy, or other reasons that the left vagus nerve is not appropriate for implant.
* Vocal cord paralysis.
* Prior therapeutic brain surgery for epilepsy within 6 months prior to the baseline visit.
* Currently implanted with an Implantable Cardiac Defibrillator (ICD), pacemaker, Deep Brain Stimulator (DBS), Responsive Neurostimulator (RNS), Spinal Cord Stimulator (SCS), Peripheral Nerve Stimulator (PNS), Sacral Nerve Stimulator (SNS), carotid baroreceptor stimulator, cochlear implant, or currently using external stimulation devices such as a Transcutaneous Electrical Nerve Stimulator (TENS). Note: Participants who currently have a commercially available VNS system for drug-resistant epilepsy and are eligible for a generator replacement (due to nearing end of life) can receive the iVEAcare Implantable Pulse Generator (IPG) alone if their existing lead has been confirmed to be functioning properly preoperatively and intraoperatively.
* Pregnant or planning to be pregnant in the next 12 months. .
* Any active malignant disease (not including skin cancer).
* Any active infection in the vicinity of the implant site or any systemic infection.
* Poorly controlled diabetes (Type I or Type II) determined by HbA1c \>8% (or \> 64 mmol/mol

Where it's running

• Royal Brisbane & Women's Hospital
  Herston, Queensland, Australia Recruiting
• The Mater
  South Brisbane, Queensland, Australia Recruiting
• Monash Health
  Clayton, Victoria, Australia Recruiting
• St. Vincent's Hospital
  Fitzroy, Victoria, Australia Recruiting
• Austin Hospital
  Heidelberg, Victoria, Australia Recruiting
• The Alfred Hospital
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Study coordinator: VP, Clinical Affairs
• Email: clinical@iveacare.com
• Phone: +1 651 728 4832

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Overnight Temporal Interference Stimulation for Temporal Lobe Epilepsy

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• Biomarkers of Response to SEEG Thermocoagulation

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• Infrared light therapy hat for adults with drug-resistant epilepsy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.