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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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Follow up of the patients at Ghent University Hospital treated with hippocampal DBS for refractory epilepsy.
Endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Questionnaires | Questionnaire for patient Questionnaire for neurologist |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | Questionnaire for patient: satisfaction regarding rechargeable DBS battery Questionnaire for neurologist: seizure frequency, satisfaction regarding rechargeable DBS battery |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure frequency per month based on seizure diary | Efficacy measured by reduction in seizure frequency before and after implantation | Every six months (up to 2 years after implantation of rechargeable device) |
| Measure | Description | Time Frame |
|---|---|---|
| Cognition | Cognition measured by neuropsychological testing | Yearly (up to 2 years after implantation of rechargeable device) |
| Number of device problems | Reporting of device problems including long charging time, bad connection between device and charger, high frequency of charging (> 1 time a day). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with refractory epilepsy treated with hippocampal DBS
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| Name | Affiliation | Role |
|---|---|---|
| Paul Boon, MD, PhD | UZ Gent | Principal Investigator |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Every six months (up to 2 years after implantation of rechargeable device) |
| Number of adverse events | Reporting of adverse events after implantation | Every six months (up to 2 years after implantation of rechargeable device) |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |