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Drug Resistant EpilepsyiVEAcare-FSNCT07640191

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

A study testing iVEAcare Neuromodulation System in people with Drug Resistant Epilepsy, run by iVEAcare at 7 sites in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 4 to 75 years
Conditions the study is for
Drug Resistant Epilepsy
What is being tested?
iVEAcare Neuromodulation System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
7 sitesAustralia
Study dates
29 Jul 2026to Jul 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 12Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

VP, Clinical Affairs contact

+1 651 728 4832

clinical@iveacare.com

7 sites in 1 country

Australia7 sites, 7 recruiting

  • Monash Health

    Clayton, Victoria, 3168

    May Ho, 03 9594 3051, Wing.Ho@monashhealth.org

    Udaya Seneviratne

    Recruiting

  • St. Vincent's Hospital

    Fitzroy, Victoria, 3065

    Emma Priest, 61 3 9231 3551, Emma.Priest@svha.org.au

    Amy Halliday

    Recruiting

  • Austin Hospital

    Heidelberg, Victoria, 3084

    Greesha Zacharia, 61 3 90357361, Greesha.zacharia@umimelb.edu.au

    Piero Perucca

    Recruiting

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029

    Kimberly Irwin, 07 36462523, Kimberley.Irwin@health.qld.gov.au

    David Reutens

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, 3004

    Jack Germaine, +61 3 9076 2029, J.Germaine@alfred.org.au

    Camilla Goulsbra, +61 3 9076 2719, C.Goulsbra@alfred.org.au

    Recruiting

  • Melbourne Health

    Parkville, Victoria, 3050

    Elle Hurley, 61 3 9342 7500, Elle.Hurley@mh.org.au

    John-Paul Nicolo

    Recruiting

  • The Mater

    South Brisbane, Queensland, 4101

    Fraser Morris, 07 3163 2850, Fraser.morris@mater.org.au

    Donald Craig

    Recruiting

Other trials in Australia

About this study

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:

Read more

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.

Being tested
iVEAcare Neuromodulation System
Medical subject headings
Drug Resistant Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iVEAcare Neuromodulation SystemDevice

    iVEAcare Neuromodulation System implant

Study groups in NCT07640191
Study groupRoleWhat they receive
iVEAcare implantExperimentalImplanted with an iVEAcare Neuromodulation System
Receives: Device: iVEAcare Neuromodulation System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. iVEAcare Neuromodulation System Safety

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

    Measured: 30 days

Secondary outcomes (8)

  1. Seizure Frequency

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

    Measured: 3 months

  2. Seizure Severity

    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.

    Measured: 3 months

  3. Change in Quality of Life

    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.

    Measured: 3 months

  4. Participant View of Overall Status

    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.

    Measured: 6 months

  5. Clinician View of Overall Status

    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.

    Measured: 6 months

  6. Depression

    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.

    Measured: 6 months

  7. Anti-seizure Medication Use

    Change from baseline in anti-seizure medications

    Measured: 6 months

  8. IPG Replacement Assessment

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

    Measured: At implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start29 Jul 2026
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07640191
Sponsor's protocol ID
CLN-000001
Acronym
iVEAcare-FS
Status last verified
Sep 2026
First submitted
3 Jun 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing iVEAcare Neuromodulation System in people with Drug Resistant Epilepsy, run by iVEAcare at 7 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact VP, Clinical Affairs (+1 651 728 4832, clinical@iveacare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

iVEAcare Neuromodulation System Safety (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07640191.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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