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Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System. | Clinical Trials | Clareo Health

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Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.

CORE-VNS: Comprehensive Outcomes Registry in Subjects With Epilepsy Treated With Vagus Nerve Stimulation Therapy

NCT03529045•LivaNova

View on ClinicalTrials.gov

Summary

Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System.

Detailed Description

The purpose of this registry is to evaluate clinical outcome and safety data in subjects with drug resistant epilepsy treated with the VNS Therapy System. The study will collect outcomes for subjects treated with VNS Therapy in a real-world setting.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Clinical diagnosis of drug resistant epilepsy treated with VNS Therapy. Eligible subjects include those not previously treated with VNS Therapy as well as subjects receiving replacement generators.
•Able and willing to comply with the frequency of study visits.
•Subject, or legal guardian, understands study procedures and voluntarily signs an informed consent in accordance with institutional policies. In the event that the subject is under the age of 18, the subject may also be required (per EC/IRB) to sign an assent affirming their agreement to participate.

Locations (62)

St. Mary's Hospital

Grand Junction, Colorado, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Research Institute of Orlando

Orlando, Florida, United States

Pediatric Epilepsy & Neurology Specialists

Tampa, Florida, United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

Via Christi Health

Wichita, Kansas, United States

Tulane University

New Orleans, Louisiana, United States

Dent Neurosciences Research Center

Amherst, New York, United States

State University of New York

Syracuse, New York, United States

Duke University Hospital

Durham, North Carolina, United States

Key Dates

Start Date

February 5, 2018

Primary Completion Date

September 11, 2024

Completion Date

September 11, 2024

Last Updated

November 22, 2024

Enrollment

827

ACTUAL participants

Conditions

EpilepsySeizuresDrug Resistant Epilepsy

Interventions

Vagus Nerve Stimulation (VNS) Therapy

DEVICE

Thalamus Seizure Detection With a Deep Brain Stimulator System

NCT06700356

Epilepsy; Seizure

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RECRUITINGPHASE3

A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

NCT05077904

Stereotypical Prolonged Seizures

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RECRUITINGPHASE3

A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

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: November 22, 2024Data 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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Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.

Inclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment