neurologische aandoeningen, hersenaandoeningen, epilepsie epilepsy epileptic seizure
Conditions
Interventions
Included patients will use tVNS for three months prior to implantation of a VNS
system.
epilepsy
Sponsors
Medisch Spectrum Twente
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
Exclusion criteria: severe cognitive impairment(s)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The predictive value of tVNS for the effects of the implantable VNS system. Positive effects of the VNS system are seizure frequency reduction, seizure intensity reduction, seizure duration reduction (obtained from patient*s seizure diary (NHS3 clinician rated scale)) and improvement in quality of life (QOLIE 31P) or mood (MADRS). Correlations between these effects and effects of tVNS will be evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| The effects of 6 weeks and 3 months of tVNS and the effects of 3, 6, 9 and 12 months of implanted VNS will be evaluated by measuring a broad set of parameters as described in the protocol (Chapter 3). | — |
Countries
The Netherlands
Outcome results
None listed