French vagus nerve stimulation (VNS) epilepsy registry
Not Applicable
Completed
- Conditions
- Drug-resistant epilepsyNervous System DiseasesEpilepsy
- Registration Number
- ISRCTN72921325
- Lead Sponsor
- ivaNova Belgium N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
1. All newly patients implanted with a VNS device
2. Patients must have received the information letter and agreed that their data will be collected and transmitted to Cyberonics for analysis
Exclusion Criteria
Does not meet inclusion criteria
The investigator should refer to the instructions for VNS Therapy use
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate, measured using a summary of participant seizure diary at baseline (pre-implant)), and 6, 12, 18 and 24 months post implant
- Secondary Outcome Measures
Name Time Method Measured at baseline (pre-implant)), and 6, 12, 18 and 24 months post implant:<br>1. Visit-wise response rate – percent (proportion) of patients who achieved a reduction of = 50% in seizure frequency of all seizure types combined from baseline at each visit time-point after VNS device implant, measured by seizure frequency data in seizure diary <br>2. Seizure frequency of all seizures combined, measured using a seizure diary<br>3. Seizure severity, measured using the NHS3 scale<br>4. Health status, measured using EQ-5D and EQ-5D-Y<br>5. Quality of life, measured using Qolie-31-P and Qolie-AD-48