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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Vagus nerve stimulation parameters #1
Vagus nerve stimulation parameters #2
Vagus nerve stimulation parameters #3
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
University Hospital Ghent
Ghent, Belgium
Efficacy of vagus nerve stimulation: responder rates and mean monthly seizure frequency reduction, mean seizure free interval, seizure severity and seizure type
Time frame: After 6 and 12 months
VNS-related side effects
Time frame: After 6 and 12 months
Battery life
Time frame: After 6 and 12 months
Quality of life: changes in QOLIE 89 score
Time frame: After 12 months
Mood assessment: changes in Beck depression scale scores
Time frame: After 12 months
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