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Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study | Clinical Trials | Clareo Health

COMPLETEDNA

Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study

Microburst VNS Therapy Feasibility Study in Subjects With Refractory Epilepsy

NCT03446664•LivaNova

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Clinical diagnosis of medically refractory epilepsy with primary generalized tonic-clonic seizures (limited to 20 subjects) or partial onset seizures including complex partial seizures with or without secondary generalization (limited to 20 subjects).
•2. Must be on adjunctive antiepileptic medications.
•3. Willing and capable to undergo multiple evaluations with functional magnetic resonance imaging (fMRI), electroencephalogram (EEG) and electrocardiogram (ECG).
•4(A) For subjects with partial onset seizures: An average of ≥ 3 countable seizures per month based on seizure diary during the 3 month baseline period and no seizure-free interval greater than 30 days during those 3 months.
•4(B) For subjects with PGTCs: Have at least ≥ 3 countable seizures during the 3 month baseline period. Note: Each seizure within a cluster may be counted as separate seizures.
•5\. 12 years of age or older.
•6\. Subject is a male or non-pregnant female adequately protected from conception. Females of childbearing potential must use an acceptable method of birth control.
•7\. Provide written informed consent-assent/Health Insurance Portability and Accountability Act (HIPAA) authorization and self-reported measures with minimal assistance as determined by the investigator.

Exclusion Criteria

•1. Currently using, or are expected to use, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
•2. A VNS Therapy System implant would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the subject.
•3. A planned procedure that is contraindicated for VNS therapy.
•4. History of implantation of the VNS Therapy System.
•5. Currently receiving treatment from an active implantable medical device.
•6. Presence of contraindications to MRI per the MRI subject screening record.
•7. Known clinically meaningful cardiovascular arrhythmias currently being managed by devices or treatments that interfere with normal intrinsic heart rate responses (e.g., pacemaker dependency, implantable defibrillator, beta adrenergic blocker medications).
•8. History of chronotropic incompetence (commonly seen in subjects with sustained bradycardia \[heart rate \< 50 bpm\]).
•9. Cognitive or psychiatric deficit that in the investigator's judgment would interfere with the subject's ability to accurately complete study assessments.
•10. History of status epilepticus within 1 year of study enrollment.
+4 more criteria

Locations (9)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Denver Colorado

Denver, Colorado, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Rush University

Chicago, Illinois, United States

Northwestern University

Evanston, Illinois, United States

Weil-Cornell Medical College

Ithaca, New York, United States

Duke University

Durham, North Carolina, United States

University of Utah

Salt Lake City, Utah, United States

Ghent University Hosptial

Ghent, Belgium

Key Dates

Start Date

February 27, 2018

Primary Completion Date

July 30, 2021

Completion Date

October 27, 2021

Last Updated

October 25, 2022

Enrollment

ACTUAL participants

Conditions

Epilepsies, PartialEpilepsy, Tonic-Clonic

Interventions

Microburst Stimulation

DEVICE

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Epilepsies, PartialEpilepsy Intractable

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 25, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study

Inclusion Criteria

Exclusion Criteria

Contribution of Genetics, Non-invasive Methods and Neuropsychology in Focal Cryptogenic Epilepsies

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