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Cerebellar stimulation to treat refractory epilepsy in children

Cerebellar stimulation to treat refractory epilepsy in children - CARE

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55396
Enrollment
9
Registered
2017-02-21
Start date
2018-11-09
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

refractory epilepsy

Interventions

- Electrical stimulation via implanted leads

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

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, including ketogenic diet if appropriate. * Age 4 - 18 years at time of inclusion (first 3 patients 7 - 18 years old)

Exclusion criteria

Exclusion criteria: * Other progressive neurologic or medical diseases, including lesions on radioimaging * Evident co-existing non-epileptic seizures * Candidate for epilepsy surgery

Design outcomes

Primary

MeasureTime frame
- Amount and severity of epilepsy

Secondary

MeasureTime frame
- Cognition corrected for age combined with assesment of behavior, development, daily life functioning and attention - EEG parameters - adverse events

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)