The Predictive Value of Transcutaneous VNS for Effect of an Implanted VNS System in Epilepsy Patients
Completed
- Conditions
- neurologische aandoeningen, hersenaandoeningen, epilepsieepilepsyepileptic seizure
- Registration Number
- NL-OMON42025
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
Age >= 18 years
Diagnosed with epilepsy
Stable epilepsy
Scheduled for an implantable VNS system
Able to read and understand Dutch
Physically and cognitively capable of using the tVNS device and participating in the measurements
Exclusion Criteria
severe cognitive impairment(s)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The predictive value of tVNS for the effects of the implantable VNS system.<br /><br>Positive effects of the VNS system are seizure frequency reduction, seizure<br /><br>intensity reduction, seizure duration reduction (obtained from patient*s<br /><br>seizure diary (NHS3 clinician rated scale)) and improvement in quality of life<br /><br>(QOLIE 31P) or mood (MADRS). Correlations between these effects and effects of<br /><br>tVNS will be evaluated. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The effects of 6 weeks and 3 months of tVNS and the effects of 3, 6, 9 and 12<br /><br>months of implanted VNS will be evaluated by measuring a broad set of<br /><br>parameters as described in the protocol (Chapter 3).</p><br>