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Completed No phase listed Observational

Vagus Nerve Stimulation Clinical Outcomes Measured Prospectively in Patients Stimulated

ClinicalTrials.gov ID: NCT01281293

Public ClinicalTrials.gov record NCT01281293. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 5:57 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01281293
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Cyberonics, Inc.
Industry
Enrollment
124 participants

Conditions and interventions

Conditions

Interventions

Not listed

Eligibility (public fields only)

Age range
7 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2010
Primary completion
Aug 15, 2018
Completion
Aug 15, 2018
Last update posted
Sep 22, 2019

2011 – 2018

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
Emory Healthcare Atlanta Georgia 30322
University of Illinois College of Medicine at Peoria Peoria Illinois 61656-1649
University of Louisville Hospital Louisville Kentucky 40202
Cornell University New York New York 10065
Vanderbilt University Medical Center Nashville Tennessee 37232
Covenant Hospital Lubbock Texas 79410
St. Luke's Milwaukee Milwaukee Wisconsin 53215

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01281293, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 22, 2019 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01281293 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →