Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy (iVEAcare-FS)
15. september 2026 oppdatert av: iVEAcare
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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: VP, Clinical Affairs
- Telefonnummer: +1 651 728 4832
- E-post: clinical@iveacare.com
Studiesteder
-
-
Queensland
-
South Brisbane, Queensland, Australia, 4101
- Rekruttering
- The Mater
-
Ta kontakt med:
- Fraser Morris
- Telefonnummer: 07 3163 2850
- E-post: Fraser.morris@mater.org.au
-
Hovedetterforsker:
- Donald Craig
-
-
Victoria
-
Clayton, Victoria, Australia, 3168
- Rekruttering
- Monash Health
-
Ta kontakt med:
- May Ho
- Telefonnummer: 03 9594 3051
- E-post: Wing.Ho@monashhealth.org
-
Hovedetterforsker:
- Udaya Seneviratne
-
Fitzroy, Victoria, Australia, 3065
- Rekruttering
- St. Vincent's Hospital
-
Ta kontakt med:
- Emma Priest
- Telefonnummer: 61 3 9231 3551
- E-post: Emma.Priest@svha.org.au
-
Hovedetterforsker:
- Amy Halliday
-
Heidelberg, Victoria, Australia, 3084
- Rekruttering
- Austin Hospital
-
Ta kontakt med:
- Greesha Zacharia
- Telefonnummer: 61 3 90357361
- E-post: Greesha.zacharia@umimelb.edu.au
-
Hovedetterforsker:
- Piero Perucca
-
Melbourne, Victoria, Australia, 3004
- Rekruttering
- The Alfred Hospital
-
Ta kontakt med:
- Jack Germaine
- Telefonnummer: +61 3 9076 2029
- E-post: J.Germaine@alfred.org.au
-
Ta kontakt med:
- Camilla Goulsbra
- Telefonnummer: +61 3 9076 2719
- E-post: C.Goulsbra@alfred.org.au
-
Hovedetterforsker:
- Hugh Simpson
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: iVEAcare implant
Implanted with an iVEAcare Neuromodulation System
|
iVEAcare Neuromodulation System implant
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
iVEAcare Neuromodulation System Safety
Tidsramme: 30 days
|
assessment of the rate of serious treatment-related (procedure, device- and/or therapy-related) adverse events
|
30 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Seizure Frequency
Tidsramme: 3 months
|
Change from baseline in frequency of daily seizures, averaged over the 90 days prior to the visit
|
3 months
|
|
Seizure Severity
Tidsramme: 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 months
|
|
Change in Quality of Life
Tidsramme: 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.
|
3 months
|
|
Participant View of Overall Status
Tidsramme: 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.
|
6 months
|
|
Clinician View of Overall Status
Tidsramme: 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 months
|
|
Depression
Tidsramme: 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.
|
6 months
|
|
Anti-seizure Medication Use
Tidsramme: 6 months
|
Change from baseline in anti-seizure medications
|
6 months
|
|
IPG Replacement Assessment
Tidsramme: At implant
|
The number of cases where the existing implanted lead works as intended with the IVEAcare IPG
|
At implant
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Terence O'Brien, MD, The Alfred Hospital and Monash University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
29. juli 2026
Primær fullføring (Antatt)
1. juli 2027
Studiet fullført (Antatt)
1. juli 2032
Datoer for studieregistrering
Først innsendt
3. juni 2026
Først innsendt som oppfylte QC-kriteriene
8. juni 2026
Først lagt ut (Faktiske)
10. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CLN-000001
Plan for individuelle deltakerdata (IPD)
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NEI
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Nei
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