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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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Patients will be prospectively randomized to 3 different treatment arms:
Twelve months after inclusion unblinding will occur. Patients in group 2 and 3 will have the option to choose between continuing neurostimulation treatment or resective surgery.
Study visits will occur every 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantation intracranial electrode with immediate stimulation | Active Comparator |
| |
| Implantation intracranial electrode without stimulation | Placebo Comparator |
| |
| Resective surgery: amygddohyppocampertomy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of an intracranial electrode | Device | Implantation of an intracranial electrode will be followed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess whether stimulation and/or resection produces a reduction in mean monthly seizure frequency that is greater than in the control group over 6 months of follow-up. | 6 months | |
| To assess whether stimulation produces a reduction in mean monthly seizure frequency that is comparable to resection at 6 and 12 months of follow-up. | at 6 and 12 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| To assess whether stimulation yields better neuropsychological outcome compared to resection at 12 months of follow-up. | at 12 months of follow-up | |
| responder rates during 3 month intervals | 3 months intervals |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Boon, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | 9000 | Belgium | |||
| UKB Universitätsklinikum Bonn |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24777136 | Derived | Chatzikonstantinou A. Epilepsy and the hippocampus. Front Neurol Neurosci. 2014;34:121-42. doi: 10.1159/000356435. Epub 2014 Apr 16. |
| Label | URL |
|---|---|
| Website of the University Hospital Ghent | View source |
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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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| amygddohyppocampertomy | Procedure | Resective surgery |
|
| mean seizure free interval during 3 month intervals | 3 month intervals |
| seizure severity and seizure type during 3-month intervals | 3-month intervals |
| quality of life: changes in QOLIE 89 score at 6 and 12 months | at 6 and 12 months |
| mood assessment: changes in Beck depression scale scores at 6 and 12 month | at 6 and 12 month |
| Safety Objectives: | during twelve months after inclusion |
| Operative and postoperative complications and long-term side effects | during twelve months after inclusion |
| Bonn |
| Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | Germany |