Cerebellar stimulation to treat refractory epilepsy in childre
- Conditions
- Refractory epilepsy
- Registration Number
- NL-OMON22556
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 9
•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.
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the efficacy of cerebellar stimulation in children with refractory epilepsy by measuring number and severity of seizures.
- Secondary Outcome Measures
Name Time Method 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.