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Vagus Nerve Stimulation Clinical Outcomes Measured Prospectively in Patients Stimulated | Clinical Trials | Clareo Health

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Vagus Nerve Stimulation Clinical Outcomes Measured Prospectively in Patients Stimulated

A Post Market, Long Term, Prospective, Observational, Multi-site Outcome Study to Follow the Clinical Course and Seizure Reduction of Patients With Refractory Seizures Who Are Being Treated With Adjunctive VNS Therapy.

NCT01281293•Cyberonics, Inc.

View on ClinicalTrials.gov

Summary

Vagus Nerve Stimulation (VNS) Therapy has been approved marked for the treatment of epilepsy since 1994. This post-market study is designed to follow the clinical course and outcomes for patients with refractory seizures treated with adjunctive VNS Therapy. Seizure frequency, seizure severity, side effects burden, depressive symptoms, global impressions, and health care utilization will be evaluated. The results of this study will provide data to guide physicians and their patients in the use of VNS Therapy for patients with refractory seizures who have failed initial trials of anti-epileptic drug (AED) therapy. The data being collected is not for the purposes of confirmatory assessment.

Detailed Description

Minimum ages eligible for the E-103 study is at least 7 years outside of the US, consistent with "Non-US" labeling and 12 years for sites in the US.

Eligibility

Age

7 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients enrolled in the study must meet all of the following criteria at Visit 1:
•(Baseline) if Screening Incl/Excl is omitted:
•1. Patients must agree to be treated with VNS Therapy. The decision to treat with VNS Therapy must have been made independent of and prior to participation in the study.
•2. Patients participating at Sites not located in the US must follow the "Non-US" labeling and be at least 7 years or older and whose epileptic disorder is dominated by partial seizures (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications; patients participating at Sites located in the United States must be 12 years or older and have partial onset seizures or must follow the indication for use statement (for VNS Therapy) in the country of origin.
•3. Patient and/or caregiver must be able to give accurate seizure counts, health outcomes information, and complete study instruments with minimal assistance.
•4. Patient or legal guardian understands study procedures and voluntarily signs an informed consent and in the United States a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional policies. In the event that the patient is under the age of 18 the patient will also be required to sign an assent affirming their agreement to participate in research according to local IRB requirements. Similar authorization is required per EC requirements, or equivalent authority.
•Additional Continuation Criteria to be evaluated at Visit 2 (Baseline):
•5. Patient must be taking at least 1 anti-epileptic drug treatment and stable on said medications for at least 8 weeks (56 days) prior to baseline. (Rescue medication may be allowed on a case-by case basis with Cyberonics approval.)
•6. Patient must have a minimum frequency of 3 seizures (excluding absence seizures, simple partial seizures and myoclonic jerks) per month (average over 2 months) prior to baseline; maximum frequency is 20 seizures per day.
•7. Patient must have no more than 4 weeks between seizures (over 2 months) prior to baseline.

Exclusion Criteria

•Patients with any of the following will not be eligible for enrollment:
•1. Patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
•2. Patient is expected to require full body magnetic resonance imaging during the clinical study.
•3. Patient has a progressive neurological condition (e.g. brain tumor etc.).
•4. In the investigator's opinion, the inability of the patient, legal guardian or reluctance of the child to comply with the frequency of clinic visits during the treatment phase.
•5. In the investigator's opinion, the patient has a history of noncompliance for seizure diary completion.
•6. Patient is currently using an investigational device or pharmacologic medication not approved by either EU or US regulatory authority.
•7. Patient has had a previous VNS Therapy implant.
•8. In the investigator's opinion, the patient is suicidal.

Locations (20)

Emory Healthcare

Atlanta, Georgia, United States

University of Illinois College of Medicine at Peoria

Peoria, Illinois, United States

University of Louisville Hospital

Louisville, Kentucky, United States

Cornell University

New York, New York, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Covenant Hospital

Lubbock, Texas, United States

St. Luke's Milwaukee

Milwaukee, Wisconsin, United States

UZ Gasthuisberg

Leuven, Belgium

Epilepsieklinik Tabor - Ladeburger Straße 15

Berlin, Germany

Albert-Ludwigs-Universität Freiburg

Freiburg im Breisgau, Germany

Key Dates

Start Date

January 1, 2011

Primary Completion Date

August 16, 2018

Completion Date

August 16, 2018

Last Updated

September 23, 2019

Enrollment

124

ACTUAL participants

Conditions

Epilepsy

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Epilepsy; Seizure

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Epilepsy

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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: September 23, 2019Data 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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Vagus Nerve Stimulation Clinical Outcomes Measured Prospectively in Patients Stimulated

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

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

Intracranial Investigation of Neural Circuity Underlying Human Mood

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

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

MEHMO Natural History and Biomarkers