Cerebellar stimulation to treat refractory epilepsy in childre
Phase 2
Recruiting
- Conditions
- refractory epilepsy10039911
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 9
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, including ketogenic
diet if
appropriate.
* Age 4 - 18 years at time of inclusion (first 3 patients 7 - 18 years old)
Exclusion Criteria
* Other progressive neurologic or medical diseases, including lesions on
radioimaging
* Evident co-existing non-epileptic seizures
* Candidate for epilepsy surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Amount and severity of epilepsy</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Cognition corrected for age combined with assesment of behavior, development,<br /><br>daily life functioning and attention<br /><br>- EEG parameters<br /><br>- adverse events</p><br>