Study for adolescents aged 12 and over

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

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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.de

Participating 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

Post-market observation register in Germany

EASEE-PEARL

The EASEE-PEARL registry study is collecting real-world data on the EASEE® System in Germany, following patients for three years. Find out more about the study design and how you can recruit your patients as study participants.

Learn more about EASEE-PEARL