Absence Epilepsy Clinical Trial
— ECVOfficial title:
ECV - Epihunter Clinical Validation
NCT number | NCT04615442 |
Other study ID # | EPI2019B |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2020 |
Est. completion date | December 31, 2021 |
Verified date | April 2022 |
Source | Epihunter NV |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 102 |
Est. completion date | December 31, 2021 |
Est. primary completion date | June 28, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years and older |
Eligibility | Inclusion Criteria: - Subjects should have an indication of having absence seizures - Subjects should be admitted for video EEG monitoring as part of their clinical practice - Age > 4 years Exclusion Criteria: - Head circumference should be compatible for wearable EEG device (40-70cm) - The subject should be able to understand instructions and refrain from removing the device from its head |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven | Leuven | |
Denmark | Danish Epilepsy Center | Dianalund | |
Georgia | Institute of Neurology and Neuropsychology | Tbilisi | |
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Epihunter NV | Boston Children's Hospital, Filadelfia Epilepsy Hospital, Institute of Neurology and Neuropsychology, Tbilisi, Georgia, KU Leuven |
United States, Belgium, Denmark, Georgia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | 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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