Vagus Nerve Stimulation Clinical Outcomes Measured Prospectively in Patients Stimulated
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.
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
- 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
- Jan 2011 (Actual)
- Primary completion
- Aug 16, 2018 (Actual)
- Completion
- Aug 16, 2018 (Actual)
- Last update posted
- Sep 23, 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 23, 2019 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01281293 live on ClinicalTrials.gov.