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This is a single-arm, observational, feasibility study to evaluate if the Halo Alert System can be used in the future to detect stroke events in individuals at risk for stroke wearing the Halo Alert System overnight.
This is a single-arm, observational, feasibility study to evaluate if the Halo Alert System can be used in the future to detect stroke events in individuals at risk for stroke wearing the Halo Alert System overnight. The Halo Alert System consists of an EEG sensor headband and is paired with a data transfer device. Approximately 300 subjects with elevated stroke risk will be enrolled and followed for a duration of 90 days. The EEG tracing for each study subject will be labeled after study conclusion with the help of clinically available information on the occurrence of a recurrent stroke. The labeled data will then be used to further develop the existing (operating room based) stroke detection algorithm and adjust the algorithm for outpatient use.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Halo Alert System | Device | The Halo Alert System consists of an EEG sensor headband and is paired with a data transfer device. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Halo Alert System to collect EEG data for algorithm development | Subject's data collection with the Halo Alert System to assess the feasibility of EEG based stroke detection at home for algorithm development. | 12 months enrollment period |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes subjects who are 18 years of age or older with a new acute ischemic stroke confirmed by neuroimaging (CT or MRI scans) as the primary reason for hospital or clinic presentation during which screening took place.
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |