Drug Resistant Epilepsy, Epilepsy, Seizures
Conditions
Keywords
VNS, VNS Therapy, Vagus Nerve Stimulation
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.
Interventions
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.
Sponsors
LivaNova
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, India, Israel, Italy, Japan, Netherlands, Poland, Portugal, Saudi Arabia, United Kingdom, United States
Outcome results
None listed