An observational study in Epilepsy, Seizures and Drug Resistant Epilepsy, sponsored by LivaNova. Completed at 62 sites in 16 countries. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by LivaNova · Observational
Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System.
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.
1,842 studies on the registry are indexed under Epilepsy; 423 are open to participants now.
This study's enrollment of 827 is above the median of 101 across 536 observational studies indexed under Epilepsy.
Browse Epilepsy studies →LivaNova is the lead sponsor of 40 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System. Eligible subjects include those receiving VNS Therapy for the first time, as well as those that are being re-implanted with VNS
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any approved VNS Therapy System (according to local regulations) may be used in this registry.
Device: Vagus Nerve Stimulation (VNS) Therapy
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.
Seizure Frequency
The average seizure frequency per month over the last 3 months (by type) will be collected
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable
Plan to share: No
Ran from Feb 2018 to primary completion in Sep 2024, 79 months.
Of 38 industry-sponsored observational studies under Epilepsy, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 59. This study's 79 months is above that.
Counting every sponsor, half of 228 studies reached it within 59 months; a quarter within 29 and three quarters within 119.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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