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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Drug Resistant Epilepsy
• Intervention / Treatment: Device: iVEAcare Neuromodulation System

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: VP, Clinical Affairs; Phone Number: +1 651 728 4832; Email: clinical@iveacare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iVEAcare implant; Implanted with an iVEAcare Neuromodulation System	Device: iVEAcare Neuromodulation System; iVEAcare Neuromodulation System implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
iVEAcare Neuromodulation System Safety	assessment of the rate of serious treatment-related (procedure, device- and/or therapy-related) adverse events	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure Frequency	Change from baseline in frequency of daily seizures, averaged over the 90 days prior to the visit	3 months
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.	3 months
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.	3 months
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.	6 months
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.	6 months
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.	6 months
Anti-seizure Medication Use	Change from baseline in anti-seizure medications	6 months
IPG Replacement Assessment	The number of cases where the existing implanted lead works as intended with the IVEAcare IPG	At implant

Collaborators and Investigators

• Sponsor: iVEAcare
• Investigators: Study Chair: Terence O'Brien, MD, The Alfred Hospital and Monash University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2032

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: CLN-000001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No