G40.1
Conditions
Interventions
Group 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 proto
Sponsors
Precisis GmbH
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactAnja Resler
Precisis GmbH
Outcome results
None listed