EASEE4YOU – A clinical investigation of the safety and efficacy of transcranial focal cortex stimulation with the EASEE® System FOR the treatment of medically refractory focal epilepsy in YOUng patients, aged 12 to 17 years.
Organizational Data
- DRKS-ID:
- DRKS00031722
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2023-04-25
- Last update in DRKS:
- 2024-03-11
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Why is the clinical trial being conducted? In the planned clinical trial, the EASEE® System will be used for the first time in adolescent patients aged 12 to 17 years. The safety, tolerability and efficacy of the therapy in this age group will be tested. What is EASEE®? EASEE® is a new neurostimulation therapy developed to treat patients with focal epilepsy who have not benefited adequately from medications. It is a medical device that is implanted, consisting of a pulse generator and an electrode. In a minimally invasive surgical procedure, the electrode is slid under the scalp and placed on the skull. The skull bone does not have to be opened for this. The pulse generator is implanted under the skin in the chest area. Stimulation is delivered automatically and continuously and is designed to reduce the patient's seizure burden. The EASEE® system has been tested in 33 adult patients to date and has received CE Mark for adult treatment in September 2022. However, no approval is yet available for minors, meaning only patients participating in this clinical trial can receive this new treatment.
Brief summary in scientific language
This is a clinical study to evaluate the efficacy and safety of transcranial focal cortex stimulation with the EASEE® System in individuals aged between 12 and 17 years. This is the first time the EASEE® System is being used in this age group. The EASEE® System was tested clinically in adults before and received CE-mark in September 2022.
Health condition or problem studied
- ICD10:
- G40.1 - Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Treatment: After completion of the baseline period, patients are implanted with the EASEE®- system. After the one-month recovery period, the EASEE® system is configured according to the protocol/ IFU and stimulation is activated.
Endpoints
- Primary outcome:
- Responder rate at month 6 of active stimulation (month 7 post-implantation). The responder rate is defined as the proportion of subjects who experienced at least 50% reduction in seizure frequency respective to baseline.
- Secondary outcome:
- 1. Responder rate at 4-, 12-, 18-, 24- and 36 months post-implantation. 2. Percentage change in seizure frequency respective to baseline at 1-, 4-, 7-, 12-, 18-, 24- and 36 months post-implantation. 3. Seizure free days at 4-, 7-, 12-, 18-, 24- and 36 months post-implantation compared to baseline. 4. Seizure severity (ordinal scale seizure diary) at 4-, 7-, 12, 18-, 24- and 36 months post-implantation compared to baseline. 5. Seizure duration (ordinal scale seizure diary) at 4-, 7-, 12, 18-, 24- and 36 months post-implantation compared to baseline. 6. QOL as assessed by QOLIE-AD-48 at 12-, 24-, and 36 months post-implantation compared to baseline. 7. Mood as assessed by BDI-II at 8-, 12-, 24- and 36 months post-implantation compared to baseline. 8. Seizure-related absence days for subject and/ or caregiver (e.g. school, work, education) at 7-, 12-, 18-, 24- and 36 months post-implantation compared to baseline.
Study Design
- Purpose:
- Treatment
- Allocation:
- N/A (single arm study)
- Control:
-
- Uncontrolled/single arm
- Phase:
- II
- 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 Neurozentrum , Epilepsiezentrum und Abteilung Stereotaktische und Funktionelle Neurochirurgie Freiburg
- University medical center Klinik für Kinderheilkunde Heidelberg
- Medical center Epilepsiezentrum Kork Kehl-Kork
- Medical center Schön Klinik Vogtareuth Vogtareuth
- University medical center Epilepsiezentrum Frankfurt Rhein-Main Frankfurt
- University medical center Neurochirurgische Klinik Heidelberg
Recruitment period and number of participants
- Planned study start date:
- 2023-04-29
- Actual study start date:
- 2023-05-24
- Planned study completion date:
- 2028-06-30
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 35
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 12 Years
- Maximum Age:
- 17 Years
- Additional Inclusion Criteria:
- 1. Subject has focal or focal to bilateral tonic-clonic seizures (ILAE classification). 2. Subject has a predominant epileptic focus that can be clearly identified as the implantation site for the electrode based on EEG and / or MRI and clinical semiology. 3. If epilepsy surgery has previously taken place, subject shall have a clearly recognizable epileptic focus and a preserved neocortex in the implantation area. 4. Subjects having seizures which are distinct, stereotypical events. 5. Subject has ≥3 seizures per month (30 days). 6. Subject has seizures which, in the opinion of the Investigator, can be reliably counted and recorded in the seizure diary by the subject and/ or caregiver for the duration of the study. 7. Subjects with drug resistant epilepsy – DRE (ILAE definition). 8. Subject had a stable dose of anti-seizure medications in the 30 days preceding enrolment. 9. Female subjects of childbearing potential must have a negative pregnancy test prior to implantation and be willing to use a reliable method of contraception (hormonal, barrier method, surgical or abstention) for duration of study. 10. Subject is aged 12 years to 17 years at the time of implantation of the EASEE System. 11. Subject and/or legal guardian understands study procedures and has voluntarily signed an informed consent. 12. Subject and/or caregiver is able and willing to comply with the frequency of study visits and required study procedures. 13. In the Investigator's opinion, subject can tolerate a neurosurgical procedure (including general anaesthesia).
Exclusion Criteria
1. Subject has been diagnosed with primary generalized epilepsy. 2. Subject has been diagnosed with psychogenic or non-epileptic seizures. 3. Subject has been diagnosed with a clinically significant or unstable medical condition (including alcohol and / or drug abuse) or progressive central nervous system disease at a significant risk of deterioration during the study period. 4. Subject has been diagnosed with active psychosis, major depression, or suicidal ideation in the preceding year (except for post-ictal psychosis). 5. Subject is pregnant. 6. Subject is currently participating in another interventional trial (e.g. device or drug). 7. Subject is anatomically unsuitable for the implantation of an EASEE® System in the opinion of the Investigator. This includes, but is not limited to, intra- or extracranial metal implants in the electrode implantation area, which cannot be safely removed during the implantation procedure (e.g., CranioFix®2 titanium clamp, artificial skull plates, screws, etc.). 8. Subject is implanted with a medical device that delivers electrical currents to the body, except for an existing VNS device that can be reliably switched off for the duration of the study. 9. Subject is unable to express presence of pain or discomfort. 10. Subject is likely to receive diathermy procedures, electroconvulsive therapy, transcranial magnetic stimulation, therapeutic ultrasound, or similar (please refer to IFU). 11. Subject and caregiver is unable to operate the EASEE® Access handheld device.
Addresses
Primary Sponsor
- Address:
- Precisis GmbHAnja ReslerMargot-Becke-Ring 869124 HeidelbergGermany
- Telephone:
- +49 6221 655 93 00
- Fax:
- +49 6221 655 93 10
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://precisis.de/de/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Abteilung Stereotaktische und Funktionelle Neurochirurgie, Klinik für Neurochirurgie, Neurozentrum, Universitätsklinikum FreiburgProf. Dr. Volker Arnd CoenenBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- +49 761 270-50630
- Fax:
- +49 761 270-50100
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/stereotaxie.html
Contact for Public Queries
- Address:
- Precisis GmbHAnja ReslerMargot-Becke-Ring 869124 HeidelbergGermany
- Telephone:
- +49 6221 655 93 00
- Fax:
- +49 6221 655 93 10
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://precisis.de/de/company/
Principal Investigator
- Address:
- Abteilung Stereotaktische und Funktionelle Neurochirurgie, Klinik für Neurochirurgie, Neurozentrum, Universitätsklinikum FreiburgProf. Dr. Volker Arnd CoenenBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- +49 761 270-50630
- Fax:
- +49 761 270-50100
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/stereotaxie.html
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Precisis GmbHMargot-Becke-Ring 869124 HeidelbergGermany
- Telephone:
- +49 6221 655 93 00
- Fax:
- +49 6221 655 93 10
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://precisis.de/de/company/
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Bundesministerium für Bildung und Forschung Dienstsitz BerlinKapelle-Ufer 110117 BerlinGermany
- Telephone:
- +49 30 18 57 0
- Fax:
- +49 30 18 57-5270
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.bmbf.de/bmbf/de/home/home_node.html
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de/ethikkommission.html
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-09-02
- Ethics committee number:
- 22-1364_1-MPDG-ff
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-12-15
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:
- After statistical analysis, the clinical trial data are comprehensively summarized in an original publication and submitted to a peer-reviewed scientific journal for publication.
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:
- DRKS00015918 - Pilotstudie, Erwachsene
- DRKS00017833 - Vorgängerstudie, Erwachsene
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