An interventional study of iVEAcare Neuromodulation System in Drug Resistant Epilepsy, sponsored by iVEAcare. Recruiting at 7 sites in Australia. Open to participants aged 4 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by iVEAcare · Not applicable, Interventional, and Treatment
Among 13 studies in Drug Resistant Epilepsy with a site in Australia — 4 open to participants now, 6 under way, 1 of them phase 3. Drug Resistant Epilepsy · Australia.
Among the 13 studies in Drug Resistant Epilepsy with a site in Australia, this one is the 7th largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2026, is one of 2 with no phase, and was the 13th registered.
257 studies on the registry are indexed under Drug Resistant Epilepsy; 108 are open to participants now.
Browse Drug Resistant Epilepsy studies →4 of the 13 studies in Drug Resistant Epilepsy with a site in Australia are open now. Recruiting first, the newest first:
Genovate-NaviFUS (Australia) Pty Ltd. · Sites in Australia
Ages 18+
Biohaven Therapeutics Ltd. · Sites in Australia, United States, Argentina and 24 more countries
Ages 18–75
Duke University · Sites in Australia, United States, Austria and 9 more countries
Ages 15+
A study can be open while its sites in Australia have not opened yet or have stopped. Only those recruiting at a site in Australia →
Of the 66 Drug Resistant Epilepsy studies recruiting now, 26 (39%) set no upper age limit and 39 (59%) stop at 75 or younger; 25 take children under 18; 6 take healthy volunteers.
This study: 4 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 7 · Phase 3 3
First in 2018; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 30 is close to the median of 30 across 202 interventional studies indexed under Drug Resistant Epilepsy.
Median enrollment 72 across the 11 interventional studies, 614 across the 2 observational. Of the 6 that completed or were terminated, 3 (50%) have results posted.
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12 of 13 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with iVEAcare as lead sponsor.
iVEAcare has 1 study filed under Drug Resistant Epilepsy — fewer than ten, so there is no comparison to draw.
4 of the studies in Drug Resistant Epilepsy with a site in Australia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06443463Biohaven Therapeutics Ltd.Long-term Safety and Tolerability of BHV-7000 | 2026-12 |
| NCT06138808Duke University5-SENSE Score Validation Study | 2027-01 |
| NCT05947656Genovate-NaviFUS (Australia) Pty Ltd.Evaluation of the NaviFUS System in Drug Resistant Epilepsy | 2027-06-01 |
| NCT07640191iVEAcareFeasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy | 2027-07 |
Add all 4 to your calendar (.ics) → With an account.
Among the 13 studies in Drug Resistant Epilepsy with a site in Australia, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Implanted with an iVEAcare Neuromodulation System
Device: iVEAcare Neuromodulation System
iVEAcare Neuromodulation System implant
iVEAcare Neuromodulation System Safety
assessment of the rate of serious treatment-related (procedure, device- and/or therapy-related) adverse events
Time frame: 30 days
Seizure Frequency
Change from baseline in frequency of daily seizures, averaged over the 90 days prior to the visit
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Anti-seizure Medication Use
Change from baseline in anti-seizure medications
Time frame: 6 months
IPG Replacement Assessment
The number of cases where the existing implanted lead works as intended with the IVEAcare IPG
Time frame: At implant
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jul 2027, 12 months after the start.
Of 102 interventional studies with no phase under Drug Resistant Epilepsy, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 50. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
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