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NCT03529045: CORE-VNS
Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.
Completed
Last updated 22 November 2024
What this trial tests
trial testing Vagus Nerve Stimulation (VNS) Therapy in Epilepsy in 827 participants. Completed in 11 September 2024.
Timeline
5 February 2018
Primary endpoint
11 September 2024
11 September 2024
11 September 2024
Quick facts
| Lead sponsor | LivaNova |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 827 |
| Start date | 5 February 2018 |
| Primary completion | 11 September 2024 |
| Estimated completion | 11 September 2024 |
| Sites | 62 locations across Italy, Japan, Netherlands, Belgium, Austria, Saudi Arabia, United Kingdom, Israel |
Drugs / interventions tested
- Vagus Nerve Stimulation (VNS) Therapy
Conditions studied
- Epilepsy — all drugs for Epilepsy →
- Seizures — all drugs for Seizures →
- Drug Resistant Epilepsy — all drugs for Drug Resistant Epilepsy →
Sponsor
LivaNova — full company profile →
Who can join
Eligibility, any sex, with Epilepsy or Seizures. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Vagus nerve stimulation therapy in people with drug-resistant epilepsy (CORE-VNS): rationale and design of a real-world post-market comprehensive outcomes registry.
Sen A, Verner R, Valeriano JP, Lee R, et al · · 2021 · cited 13× · PMID 35018342 · DOI 10.1136/bmjno-2021-000218 -
Vagus nerve stimulation in Lennox-Gastaut syndrome: Twenty-four-month data and experience from the CORE-VNS study.
Lyons P, Wheless J, Verner R, Ferreira J, et al · · 2025 · cited 12× · PMID 39921595 · DOI 10.1111/epi.18289 -
Reduction of generalized tonic-clonic seizures following vagus nerve stimulation therapy: CORE-VNS Study 24-month follow-up.
Suller Marti A, Verner R, Keezer M, Andrade A, et al · · 2025 · cited 6× · PMID 40167365 · DOI 10.1111/epi.18371 -
Baseline characteristics and predictors for early implantation of vagus nerve stimulation therapy in people with drug-resistant epilepsy: Observations from an international prospective outcomes registry (CORE-VNS).
Kwan P, Boffini M, Fahoum F, El Tahry R, et al · · 2024 · cited 6× · PMID 39180426 · DOI 10.1002/epi4.13015 -
Practical Considerations for the rapid titration of VNS.
Tahry RE, Dibué M, Szmalec A, Patel R, et al · · 2025 · cited 3× · PMID 39803413 · DOI 10.1016/j.ebr.2024.100734 -
Special Issue: Abstracts of the 11<sup>th</sup> Congress of the European Academy of Neurology, Helsinki, Finland.
· 2025 · cited 1× · PMID 40542608 · DOI 10.1111/ene.70193 -
CORE-VNS: Dosing and titration of VNS therapy in contemporary clinical practice.
Verner R, Beraldi F, Tzadok M, Fahoum F, et al · · 2026 · PMID 41777812 · DOI 10.1016/j.ebr.2026.100847
Verify or expand the search:
- PubMed search for NCT03529045
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Epilepsy
Currently open trials in the same condition.
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- NCT07224191 — Hippocampal Oscillations During Exploration · NA · recruiting
- NCT07219407 — A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures · Phase 2 · recruiting
- NCT07417280 — LIFUS For Neurological Disorders · NA · recruiting
- NCT07490769 — Levetiracetam Three Times Daily in Epilepsy · Phase 3 · recruiting
Other LivaNova trials
Trials by the same sponsor.
- NCT05975931 — IMPACT of AspireSR® for VNS Therapy on Healthcare Resource Utilisation and Clinical Outcomes. · terminated
- NCT04950894 — Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation · NA · active not recruiting
- NCT04779814 — Non-interventional Study Describing Healthcare Resource Utilisation and Clinical Outcomes Associated With VNS Therapy in · terminated
- NCT04753385 — The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment mea · terminated
- NCT04282681 — XLTCS - Accelerometer Data Collection in an Epilepsy Monitoring Unit (EMU) · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03529045 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by LivaNova
- Last refreshed: 22 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03529045.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing