EASEE® System - Long-term registry on Epilepsy Evolution in subjects treated with transcranial focal cortex stimulatio
- Conditions
- Epilepsy
- Registration Number
- DRKS00032576
- Lead Sponsor
- Precisis GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
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)
NA
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method •Quantify and characterize the long-term safety of treatment with the device in terms of device and/or procedure related (serious) adverse events<br>•Characterize seizure control evolution over time <br>•Assess the evolution of Patient Reported Outcomes (Quality of life, mood, neurocognition and device appreciation) over the study period<br>•Evaluate the long-term performance of the device <br>•Evaluate the overall safety of treatment with the device during the study