Epilepsy
Conditions
Interventions
Group 1: Implantation with brain neurostimulation EASEE® System per standard of care
Sponsors
Precisis GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subject who meets the indication for use of the EASEE® System and with an implant procedure scheduled within the next quarter, OR subject previously enrolled in one of the clinical investigations EASEE II or PIMIDES I and currently implanted with an EASEE® System. 2. Subject with observable manifestation of distinct seizures which are stereotypical events and can be reliably counted, in the opinion of the Investigator, by the patient or a caregiver and which can be reliably recorded in a seizure diary 3. Subject willing to complete a seizure diary and share it with the investigator 4. Subject able and willing to provide written informed consent 5. Subjects with a life expectancy = 15 months 6. Subject not participating in any interventional study (drug, device, food regimen)
Exclusion criteria
Exclusion criteria: NA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the effectiveness of treatment in terms of seizure control with the EASEE® System compared to historical control in subjects with drug-refractory epilepsy after 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| • Quantify and characterize the long-term safety of treatment with the device in terms of device and/or procedure related (serious) adverse events • Characterize seizure control evolution over time • Assess the evolution of Patient Reported Outcomes (Quality of life, mood, neurocognition and device appreciation) over the study period • Evaluate the long-term performance of the device • Evaluate the overall safety of treatment with the device during the study | — |
Countries
Germany
Contacts
Public ContactElisabeth Kaufmann
LMU
Outcome results
None listed