G40.1 G40.2
Conditions
Interventions
Group 1: After completing the baseline period, patients will undergo the implantation procedure for the EASEE® System. This will be followed by a healing period of one month. The device will then be c
Sponsors
Precisis AG
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with a clinical diagnosis of focal seizures or focal to bilateral tonic clonic seizures. 2. Patients with a diagnosis of lateral temporal lobe epilepsy or extra-temporal lobe epilepsy. 3. Patients with a predominant epileptic focus, which can be clearly identified as the site of implantation for the electrode based on EEG and clinical presentation. 4. Patients who have failed treatment with a minimum of two anti-seizure medications (used in appropriate doses). 5. Patients having seizures which are distinct, stereotypical events and can be reliably counted, in the opinion of the Investigator, by the patient or caregiver and recorded in a seizure diary. 6. Patients having an anticipated average of 3-300 partial-onset seizures (focal to bilateral tonic clonic seizures) during the baseline period. 7. Patients taking a constant dose of antiepileptic medication(s) over the most recent 28-day period prior to the baseline period (use of medication for acute treatment of seizures is allowed). 8. Patients between the ages of 18 and 75 years. 9. Patients able and willing to provide appropriate consent prior to study procedures. 10. Patients able to complete regular office appointments per the protocol requirements, including behavioral (mood) surveys and neuropsychological testing. 11. Patients willing to be implanted with the EASEE® System as a treatment for his/her seizures.
Exclusion criteria
Exclusion criteria: 1. Patients with a diagnosis of mesial temporal lobe epilepsy. 2. Patients with a previous diagnosis of psychogenic or non-epileptic seizures, which are semiologically non-distinguishable from epileptic seizures. 3. Patients with a diagnosis of primarily generalized seizures. 4. Patients with unprovoked status epilepticus in the preceding 6 months prior to enrolment. 5. Patients with a clinically significant or unstable medical condition (including cardiac conditions, alcohol and/or drug abuse) or a progressive central nervous system disease. 6. Patients with a diagnosis of active psychosis, major depression or suicidal ideation in the preceding year (excluding postictal psychosis). 7. Females who are pregnant or have a pregnancy wish in the next 2 years. 8. Patients enrolled in a therapeutic investigational drug or device trial. 9. Patients who are anatomically not eligible for EASEE® System implant in the opinion of the Investigator. 10. Patients who have had resective surgery to treat epilepsy in the target region of implantation. 11. Patients with an implanted electronic medical device that delivers electrical energy to the body (e.g. VNS, DBS, cardiac pacemeaker or defibrillator). 12. Patients requiring scheduled MRIs during the study phase. 13. Patients who are unable, or do not have the necessary assistance, to properly operate the EASEE® Access handheld device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the safety of the EASEE® System evaluated at 4 months post-implant. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Seizure frequency: baseline seizure frequency and responder rate compared to respective values at 4 months, 8 months and 16 months post-implant (seizure diary data) 2. Seizure severity: baseline seizure severity compared to seizure severity at 8 months and 16 months post-implant (SSQ questionnaire) 3. Epileptiform activity: baseline measurements of scalp EEG compared to data collected at 1 month, 8 months and 16 months post-implant (EEG recordings) 4. Quality of life: baseline subject rated quality of life compared to 8 months and 16 months post-implant (QOLIE-31-P questionnaire) 5. Mood: baseline subject rated mood compared to 8 months and 16 months post-implant (NDDI-E questionnaire) 6. Neurocognition: baseline neurocognition compared to 8 months and 16 months post-implant (EpiTrack cognitive test) | — |
Countries
Belgium, Germany
Contacts
Public ContactAnja Resler
Precisis AG
Outcome results
None listed