Epilepsy
Conditions
Brief summary
Patients with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 3 arms with different vagus nerve stimulation paradigms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.
Interventions
PROCEDUREVagus nerve stimulation paradigm #1
Vagus nerve stimulation parameters #1
PROCEDUREVagus nerve stimulation paradigm #2
Vagus nerve stimulation parameters #2
PROCEDUREVagus nerve stimulation paradigm #3
Vagus nerve stimulation parameters #3
Sponsors
Research Foundation Flanders
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 16 years or older * At least 1 seizure/month with alteration of consciousness * Documented seizure diary, at least 3 months prior to implantation (baseline) * No change in anti-epileptic drugs 1 month before implantation * At least one or more AEDs
Exclusion criteria
* Active cardiac, pulmonary or gastrointestinal disease * Vagotomy * Concomitant use of an investigational drug * Unstable medical condition * Unstable psychiatric condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of vagus nerve stimulation: responder rates and mean monthly seizure frequency reduction, mean seizure free interval, seizure severity and seizure type | After 6 and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| VNS-related side effects | After 6 and 12 months |
| Battery life | After 6 and 12 months |
| Quality of life: changes in QOLIE 89 score | After 12 months |
| Mood assessment: changes in Beck depression scale scores | After 12 months |
Countries
Belgium, United States
Outcome results
None listed