Refractory epilepsy
Conditions
Interventions
Electrical stimulation of the brain via implanted leads
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
Inclusion criteria: • Refractory epilepsy for at least one year, with a seizure frequency of at least four per month. • Failure of at least three adequately tried AED regimens, as determined by the principal investigator, including ketogenic diet if appropriate. • Age 4 – 18 years at time of inclusion. The first 3 patients are at least 7 years old. • Definite diagnosis of epilepsy syndrome as reported by treating clinician according to international standards and confirmed by recruitment team. • Written informed consent of parents/caretakers.
Exclusion criteria
Exclusion criteria: • Other progressive neurologic or medical diseases. • Evident co-existing non-epileptic seizures. • Candidate for resective epilepsy surgery. • Inability to complete neuropsychological tests or complete seizure diaries by caretakers. • Vagal nerve stimulators in situ. • Surgical contraindications such as coagulation disorders. • Contraindications for MRI. • Anatomical abnormalities of skull and posterior fossa, precluding safe lead placement and fixation. • Immune deficiency. • Insufficient space or subcutaneous fat to safely implant stimulator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the efficacy of cerebellar stimulation in children with refractory epilepsy by measuring number and severity of seizures. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine safety and long term effects of (intermittent-) continuous cerebellar stimulation by monitoring number of adverse events, cognitive development, and effects on daily life and behavior. | — |
Contacts
Public ContactW Busser
Erasmus MC
Outcome results
None listed