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New treatment option for Drug Resistant Epilepsy
Official title Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy
ClinicalTrials.gov ID: NCT07640191
What this study is testing
- What it's testing
- The purpose of this study is to assess the safety and performance of the iVEAcare Neuromodulation System for the treatment of drug-resistant epilepsy. The main questions it aims to answer are: What medical problems do participants have when being implanted with and using the iVEAcare system?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 75
You may be able to join if
- 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 must be at a steady state for a minimum of 30 days and remain stable through the 6-month post-activation study visit. Rescue...
You likely can't join if
- 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...
- Known vagal neuropathy, or other reasons that the left vagus nerve is not appropriate for implant.
- Vocal cord paralysis.
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- South Brisbane, Queensland, Australia
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include South Brisbane, Queensland, Australia; Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.