Epilepsy
Conditions
Interventions
None listed
Sponsors
Academisch Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Patients treated with Vagus Nerve stimulation as part of usual patient care 2) Age 18 years or older 3) Informed consent
Exclusion criteria
Exclusion criteria: 1) Evidence of a progressive cerebral lesion, degenerative disorder, malignancy or a history with malignancy in the past 5 years 2) Unstable medical disease (i.e. cardiovascular, hepatic, renal, gynaecologic, musculoskeletal, gastrointestinal, metabolic, endocrine) in the last 2 years 3) Documented history with generalized status epilepticus in the past three months 4) High risks for complications (obstructive respiratory disease, gastric disorders, cardiac rythm disorders) 5) A history of alcohol or drug abuse, of psychiatric disorder requiring electro-convulsive therapy, chronic use of major tranquillisers (neuroleptics, antidepressants, or MAO inhibitors) in the past 6 months 6) Regularly treatment with antihistamines, metoclopramide or CNS-active compounds 7) Treatment with an experimental drug during the past 30 days 8) Subjects who are schizophrenic or have exhibited any psychotic symptomatology
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| > 50% seizure reduction | — |
Secondary
| Measure | Time frame |
|---|---|
| Demographic data and epilepsy specific data: - age - gender - seizure and epilepsy syndrome classification - duration of epilepsy - seizure frequency (diary) - seizure severity Neuro-immunologic variables (pro-, and anti-inflammatory cytokines and neuroprotective cytokines) Biochemical variables (serotonin metabolites, GABA, glutamate) Endocrine variables (cortisol) Neuropsychologic variables (mood and quality of life) | — |
Countries
Netherlands
Outcome results
None listed