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The goal of this clinical trial is to demonstrate the safety and effectiveness of focal cortex stimulation with the EASEE(R) System in a large cohort of subjects with medically refractory focal epilepsy. The main questions it aims to answer are:
Participants will be asked to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Participants in the Intervention group receive brain neurostimulation. Participants do not feel if they are stimulated or not. |
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| Control group | Sham Comparator | Participants in the Control group have stimulation parameters turned off. Participants do not feel if they are stimulated or not. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable minimaly invasive brain stimulator | Device | Participants are implanted with an electrode under the skin and above the skull. The electrode is connected to an implantable pulse generator in the chest area. The system is intended for focal cortex stimulation to treat medically refractory epilepsy. The stimulation is activated (turned ON) for 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage reduction in the monthly seizure rate [Effectiveness] | Percentage reduction in the monthly seizure rate during months 5 and 6 post-randomization compared to 3 months pre-implant baseline in the Intervention group versus the Control group. | Baseline and months 5 and 6 |
| Incidence of Serious Adverse Events [Safety and Tolerability] |
| From implant to days 28 and 84 post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure Frequency Responder Rate | Comparison between study arms of the proportion of patients who reach at least 50 % of monthly seizure frequency reduction between the baseline and the follow-up months 5 and 6 | from Baseline to 6 months |
| Beck Depression Inventory (BDI-II) accross Arms [Patient Reported Outcome] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Perry Rice | Contact | +49 6221 6559321 | p.rice@precisis.de | |
| Aude Yulzari | Contact | +49 6221 6559321 | a.yulzari@precisis.de |
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The study results will be submitted for publication in peer-review journal(s) after completion of study endpoints. Research ideas can be shared with the Primary Investigators for analysis.
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Implantable minimaly invasive brain stimulator | Device | Participants are implanted with an electrode under the skin and above the skull. The electrode is connected to an implantable pulse generator in the chest area. The system is intended for focal cortex stimulation to treat medically refractory epilepsy. The stimulation is not activated (turned OFF) for 6 months, than activated (turned ON) for 12 months. |
|
Comparison of Beck Depression Inventory (BDI-II) changes form baseline to follow-up month 6 between the study arms. BDI-II scores from 0 (no or minimal depression) to 63 (severe depression). |
| Baseline to 6 months |
| Beck Depression Inventory (BDI-II) in the Intervention Group [Patient Reported Outcome] | Evaluation of Beck Depression Inventory (BDI-II) changes form baseline to follow-up month 6 between in the Intervention group. BDI-II scores between 0 (no or minimal depression) to 63 (severe depression). | Baseline to 6 months |
| Quarterly Seizure Frequency Evaluation | Percentage change in the quarterly seizure frequency between baseline and one year after stimulation start | Baseline to 18 months |