NCT03446664 (Microburst) is a NA clinical trial of Microburst Stimulation in Epilepsies, Partial, sponsored by LivaNova.

Who is sponsoring NCT03446664?

NCT03446664 is sponsored by LivaNova.

What drugs are being tested in NCT03446664?

Interventions in NCT03446664: Microburst Stimulation.

What condition does NCT03446664 study?

NCT03446664 studies Epilepsies, Partial, Epilepsy, Tonic-Clonic.

Is NCT03446664 still recruiting?

NCT03446664 is currently completed. Last updated 25 October 2022.

Last reviewed 2022-10-25 · How we verify

NCT03446664: Microburst

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study

Completed NA Last updated 25 October 2022

What this trial tests

NA trial testing Microburst Stimulation in Epilepsies, Partial in 33 participants. Completed in 27 October 2021.

Timeline

27 February 2018

Primary endpoint
30 July 2021

27 October 2021

Quick facts

Lead sponsor	LivaNova
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	27 February 2018
Primary completion	30 July 2021
Estimated completion	27 October 2021
Sites	9 locations across Belgium, United States

Drugs / interventions tested

Microburst Stimulation

Conditions studied

Epilepsies, Partial — all drugs for Epilepsies, Partial →
Epilepsy, Tonic-Clonic — all drugs for Epilepsy, Tonic-Clonic →

Sponsor

LivaNova — full company profile →

Who can join

12 and older, any sex, with Epilepsies, Partial or Epilepsy, Tonic-Clonic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Role of the Cholinergic Anti-Inflammatory Reflex in Central Nervous System Diseases.
Ramos-Martínez IE, Rodríguez MC, Cerbón M, Ramos-Martínez JC, et al · · 2021 · cited 26× · PMID 34948222 · DOI 10.3390/ijms222413427
Modulation of the thalamus by microburst vagus nerve stimulation: a feasibility study protocol.
Verner R, Szaflarski JP, Allendorfer JB, Vonck K, et al · · 2023 · cited 12× · PMID 37384278 · DOI 10.3389/fneur.2023.1169161
Feasibility study of microburst VNS therapy in drug-resistant focal and generalized epilepsy.
Drees C, Afra P, Verner R, Kaye L, et al · · 2024 · cited 11× · PMID 38499287 · DOI 10.1016/j.brs.2024.03.010
Optimized microburst VNS elicits fMRI responses beyond thalamic-specific response from standard VNS.
Szaflarski JP, Allendorfer JB, Begnaud J, Ranuzzi G, et al · · 2024 · cited 7× · PMID 38532258 · DOI 10.1002/acn3.52029
Resting-state functional connectivity changes with microburst vagus nerve stimulation therapy.
Allendorfer JB, Nenert R, Shamshiri E, Ranuzzi G, et al · · 2025 · cited 3× · PMID 40432245 · DOI 10.1002/epi4.70059
Compatibility of Standard Vagus Nerve Stimulation and Investigational Microburst Vagus Nerve Stimulation Therapy with fMRI.
Middlebrooks EH, Szaflarski JP, Begnaud J, Thaker A, et al · · 2024 · cited 3× · PMID 38448165 · DOI 10.3174/ajnr.a8235
Assessing an fMRI-guided titration paradigm for microburst VNS therapy.
Vonck K, Verner R, Ranuzzi G, Patel R, et al · · 2026 · PMID 41592420 · DOI 10.1016/j.eplepsyres.2026.107734

Verify or expand the search:

Other recruiting trials for Epilepsies, Partial

Currently open trials in the same condition.

NCT06550726 — High-resolution Multi-parametric Magnetic Resonance Imaging for Focal Epilepsy · NA · recruiting
NCT06967012 — A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures · Phase 4 · recruiting
NCT06590896 — Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures · Phase 2 · recruiting
NCT05248269 — Thermocoagulation in Drug Resistant Focal Epilepsy · NA · active not recruiting
NCT04309812 — Transcranial Direct Current to Treat Epilepsy at Home · NA · active not 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 NCT03446664 (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: 25 October 2022

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/NCT03446664.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing