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

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

Detailed Description
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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.

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

Conditions
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Epilepsy, Seizures, Drug Resistant Epilepsy

Intervention / Treatment
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* Device: Vagus Nerve Stimulation (VNS) Therapy


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: • There are no exclusion criteria in this study. Investigators should refer to the local instructions for use for VNS Therapy.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VNS Therapy<br>Any approved VNS Therapy System (according to local regulations) may be used in this registry. | Device: Vagus Nerve Stimulation (VNS) Therapy<br>* The VNS Therapy System is a commercially available device that will be used by licensed medical practitioners trained in the use of VNS Therapy, per the practitioners' medical judgement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure Frequency | The average seizure frequency per month over the last 3 months (by type) will be collected | Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable | 
| Maximum Seizure Free Period | The maximum seizure free period over the last 3 months will be collected | Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable | 
| Seizure Severity | Seizure severity is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe | Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable | 
| Post-ictal Severity | Seizure severity is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe | Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable | 
| Change in Quality of Life | Quality of life is a categorical outcome and will be rated by the subject using the following categories: Very good: could hardly be better, Pretty good, Good and bad parts about equal, Pretty bad, Very bad: could hardly be worse | Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable | 
| Quality of Sleep | Quality of sleep will be reported using the Pittsburgh Sleep Quality Index for subjects 18 years and older and using the Children's Sleep Habit Questionnaire for subjects 2-17 years old; quality of sleep will not be assessed in children under 2 years old | Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable | 
| Anti-epileptic Drug Use | The name and dose of anti-epileptic drugs used will be collected on a case report form | Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable | 
| Rescue Drug Use | The number of times a rescue drug was used will be collected | Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable | 
| Seizure Related Emergency Department Visits | The number of times a patient had a seizure related emergency department (ED) visit will be collected | Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable | 
| Seizure Related Hospitalizations | The number of times a patient had a seizure related inpatient hospitalization and the length of each stay will be collected | Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VNS, VNS Therapy, Vagus Nerve Stimulation