Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.
- Conditions
- SeizuresDrug Resistant EpilepsyEpilepsy
- Registration Number
- NCT03529045
- Lead Sponsor
- LivaNova
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 827
- 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.
• There are no exclusion criteria in this study. Investigators should refer to the local instructions for use for VNS Therapy.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of Sleep 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 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
Seizure Severity 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 is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe
Change in Quality of Life 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 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
Rescue Drug Use Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable The number of times a rescue drug was used will be collected
Seizure Related Emergency Department Visits Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable The number of times a patient had a seizure related emergency department (ED) visit will be collected
Seizure Related Hospitalizations Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable The number of times a patient had a seizure related inpatient hospitalization and the length of each stay will be collected
Maximum Seizure Free Period Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable The maximum seizure free period over the last 3 months will be collected
Post-ictal Severity 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 is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe
Seizure Frequency Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable The average seizure frequency per month over the last 3 months (by type) will be collected
Anti-epileptic Drug Use Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable The name and dose of anti-epileptic drugs used will be collected on a case report form
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (61)
St. Mary's Hospital
🇺🇸Grand Junction, Colorado, United States
Georgetown University Medical Center
🇺🇸Washington, 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
Scroll for more (51 remaining)St. Mary's Hospital🇺🇸Grand Junction, Colorado, United States