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NCT Number: NCT07640191

Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy

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? Does the iVEAcare neurostimulator reduce seizure frequency and severity in patients with drug-resistant epilepsy? Does the iVEAcare neurostimulator improve quality of life in patients with drug-resistant epilepsy?

All participants will be implanted with an iVEAcare neurostimulator, and researchers will look at whether any medical problems are caused by the implant procedure or device, and how stimulation changes seizure frequency and severity and participant quality of life compared to when the participant enrolled.

Participants will:

Be implanted with an iVEAcare device. Visit the clinic 1-month, 3-months, 6-months, 1-year, 18-months and then annually through 5 years where they will be asked to answer questionnaires about their seizures and quality of life.

Keep a diary of the number of seizures they have each day.

Recruiting

Interested in participating?

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Key information

Conditions

Drug Resistant Epilepsy Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

4 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Mater, South Brisbane, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iVEAcare Neuromodulation System

Device

iVEAcare Neuromodulation System implant

Primary outcomes

  1. iVEAcare Neuromodulation System Safety

    Time frame: 30 days

    assessment of the rate of serious treatment-related (procedure, device- and/or therapy-related) adverse events

Secondary outcomes

  1. Seizure Frequency

    Time frame: 3 months

    Change from baseline in frequency of daily seizures, averaged over the 90 days prior to the visit

  2. Seizure Severity

    Time frame: 3 months

    Change from baseline in the Seizure Severity Questionnaire (SSQ) Score, which measures seizure intensity and duration on a scale of 1-7 where lower scores indicate lower seizure severity.

  3. Change in Quality of Life

    Time frame: 3 months

    Change from baseline in Quality of Life as measured by the Quality of Life in Epilepsy (QOLIE-31) Questionnaire on a scale from 0-100, where higher scores are considered better quality of life.

  4. Participant View of Overall Status

    Time frame: 6 months

    Subject Global Impression of Change (SGIC) compared to baseline. SGIC is a single question where the participant indicates their status compared to baseline with 7 options ranging from Very Much Improved to Very Much Worse.

  5. Clinician View of Overall Status

    Time frame: 6 months

    Clinical Global Impression - Improvement (CGI-I) compared to baseline. CGI-I is a single question where the physician indicates the participant's status compared to baseline with 5 options ranging from Much Better to Much Worse.

  6. Depression

    Time frame: 6 months

    Change from baseline in the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) on a scale from 6-24, where lower scores are considered less depression.

  7. Anti-seizure Medication Use

    Time frame: 6 months

    Change from baseline in anti-seizure medications

  8. IPG Replacement Assessment

    Time frame: At implant

    The number of cases where the existing implanted lead works as intended with the IVEAcare IPG

Study contacts

Contact information is provided by the study sponsor or research team.

VP, Clinical Affairs

CONTACT

[email protected]

+1 651 728 4832

Sponsors and collaborators

Lead sponsor

iVEAcare

Industry

Registry information

Acronym: iVEAcare-FS

Important dates

Study start
2026
Primary completion
2027
Study completion
2032
First posted
Jun 10, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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