EASEE® System - Long-term registry on Epilepsy Evolution in subjects treated with transcranial focal cortex stimulation
Organizational Data
- DRKS-ID:
- DRKS00032576
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2023-08-29
- Last update in DRKS:
- 2023-11-22
- Registration type:
- Prospective
Acronym/abbreviation of the study
EASEE-LEE
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
This is a prospective, open-label, observational, multicenter, international study.
Health condition or problem studied
- Free text:
- Epilepsy
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Implantation with brain neurostimulation EASEE® System per standard of care
Endpoints
- Primary outcome:
- 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:
- • 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
Study Design
- Purpose:
- Treatment
- Allocation:
- N/A (single arm study)
- Control:
-
- Uncontrolled/single arm
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Single (group)
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center LMU Munich
- University medical center Philipps-Universität Marburg Marburg
Recruitment period and number of participants
- Planned study start date:
- 2023-09-01
- Actual study start date:
- 2023-11-08
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 40
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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
NA
Addresses
Primary Sponsor
- Address:
- Precisis GmbH69117 HeidelbergGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- LMUPD Dr. med. Elisabeth KaufmannMarchioninistrasse 1581377 MunichGermany
- Telephone:
- +49 (0) 89 4400-75680
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- LMUPD Dr. med. Elisabeth KaufmannMarchioninistrasse 1581377 MunichGermany
- Telephone:
- +49 (0) 89 4400-75680
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- LMUPD Dr. med. Elisabeth KaufmannMarchioninistrasse 1581377 MunichGermany
- Telephone:
- +49 (0) 89 4400-75680
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Precisis GmbH69117 HeidelbergGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Med. Fakultät der LMUPettenkoferstraße 880336 MünchenGermany
- Telephone:
- +49-89-440055191
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.med.uni-muenchen.de/einrichtungen/ethik/index.html
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-05-25
- Ethics committee number:
- 23-0403
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-07-24
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry