EASEE4YOU
EASEE for young patients
A clinical study evaluating transcranial focal cortex stimulation for medically refractory epilepsies in adolescents.
Duration of clinical investigation: 3 years > 10 visits
Course of study
- Screening & Enrollment, followed by 2 month baseline (prospective data collection).
- Implantation: Study-related procedure.
- Device activation after 4 weeks of recovery.
- Follow-up visits taking place 4-, 8-,12-,18-,24- and 30-month post implantation surgery (visit no. 4-9).
- End of study 36 month after implantation surgery.
Patient profile & key inclusion criteria:
- patient is 12-17 years old at the time of implantation.
- patient suffers from medication-refractory focal seizures or focal to bilateral tonic-clonic seizures (failed treatment attempts with at least two anti-epileptic drugs).
- there is a predominant seizure focus clearly identifiable as the implantation site (EEG and/or MRI, as well as seizure semiology).
- patient suffers at least 3 seizures per month (reliably counted and documented in the seizure diary).
- In case of previous epilepsy surgery: Identifiable focus and intact neocortex in the implantation region.
Scientific research lead EASEE4YOU
Prof. Steffen Syrbe
University Hospital Heidelberg, coordinating principal investigator among the pediatric neurologists
Prof. Volker A. Coenen
University Hospital Freiburg, head of the clinical trial in Germany
Contact
Do you have further questions about the study design and how you can recruit your patients as study participants?
Please feel free to contact us!
Send an email to info@precisis.deParticipating active centers
Active centers in Germany and Austria:
- Epilepsiezentrum Freiburg, Dr. San Antonio Arce
- Universitätsklinikum Heidelberg, Prof. Syrbe
- Epilepsiezentrum Diakonie Kork, PD Dr. Bast
- Schön Klinik Vogtareuth, Dr. Hartlieb
- Epilepsiezentrum Frankfurt, PD Dr. Schuber-Bast
- Klinik Mara, Bethel/Bielefeld, Dr. Polster
- Universitätsklinikum Bonn, Prof. Klotz
- Charité Berlin, Prof. Kaindl
- Kepler Universitätsklinikum Linz, Dr. Gröppel
- AKH Wien (MUW), Prof. Feucht
EASEE®-PEARL
The current registry study PEARL (Providing Early Assessment in Real Life) is investigating the real-word effect of the EASEE®-system on seizure frequency in drug-refractory focal epilepsies over a period of 3 years. Find out more about the study design and how you can recruit your patients as study participants.
