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| Name | Class |
|---|---|
| Filadelfia Epilepsy Hospital | OTHER |
| KU Leuven | OTHER |
| Boston Children's Hospital | OTHER |
| Institute of Neurology and Neuropsychology, Tbilisi, Georgia |
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The goal of this prospective study is to validate a wearable EEG seizure detection solution compared to video EEG. Subjects that undergo a clinical video EEG are asked to additionally wear a wearable EEG headband for up to 2 periods of 4h during the video EEG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental | Subjects that undergo a clinical video EEG are asked to additionally wear a wearable EEG headband for up to 2 periods of 4h during the video EEG. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epihunter | Device | Subjects wear epihunter during routine video EEG |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity for electrographic seizures of study device compared to video EEG | The sensitivity for electrographic seizures by the study device compared to manually annotated electrographic seizures on non-video EEG is > 0.90 (median sensitivity per patient) | 9 months |
| Number of false alarms by study device per hour | The number of false alarms by the study device < 0.1 per hour (median false detection rate per recording) | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility testing of automated behavioral testing triggered by automated detection | Assess if automated behavioral testing triggered by automated detection can be used to automatically assess awareness during an absence seizure. Successful if subjects DO NOT react to the testing during an unaware seizure, and DO react during an aware seizure. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dirk Loeckx, PhD | Epihunter NV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States | ||
| UZ Leuven |
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| ID | Term |
|---|---|
| D012640 | Seizures |
| D004832 | Epilepsy, Absence |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| UNKNOWN |
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| Leuven |
| Belgium |
| Danish Epilepsy Center | Dianalund | Denmark |
| Institute of Neurology and Neuropsychology | Tbilisi | Georgia |
| D004829 | Epilepsy, Generalized |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D000073376 | Epileptic Syndromes |