Health Condition 1: G409- Epilepsy, unspecified
Conditions
Interventions
Intervention1: nil: nil
Control Intervention1: Nil: Nil
Sponsors
LivaNova USA Inc
Eligibility
Inclusion criteria
Inclusion criteria: To be eligible for enrollment, the subject must meet the following criteria: 1 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. 2 Able and willing to comply with the frequency of study visits. 3 Subject, or legal guardian, 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 to sign an assent affirming their agreement to participate.
Exclusion criteria
Exclusion criteria: 1 There are no exclusion criteria. Investigators should refer to the local instructions for use for VNS Therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Seizure frequency 2 Maximum seizure free period 3 Seizure severity 4 Post-ictal severity 5 Quality of life 6 Quality of sleep 7 Anti-epileptic drug use 8 Rescue drug use 9 Seizure related emergency department visits 10 Seizure related inpatient hospitalizations 11 VNS Therapy feature use 12 Safety- All deaths, adverse events related to VNS Therapy device deficiencies Timepoint: Baseline, 3, 6, 12, 24, 36 and 60 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Finland, India, Israel, Italy, Netherlands, Poland, Saudi Arabia, United Kingdom, United States of America
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Private Limited
Outcome results
None listed