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Therapeutic Area Stroke
Principal Investigator Dr. Emiliya Melkumova
Min Age 18 Years
Gender Any


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 (Muse-S headband from Interaxon, Inc., Toronto Canada) paired with a data transfer device (Zeit Loop, Zeit Medical, Inc., Redwood City, CA). 

Study Details

Inclusion Criteria

1. New ischemic stroke confirmed by neuroimaging (CT or MRI scans) as the reason for current hospital admission or stroke clinics visit. Time from stroke to enrollment should be ≤ 2 weeks 2. Patient is discharged to home 3. Recurrence Risk Estimator (RRE)-90 is greater than 2

Exclusion Criteria

1. Subject is a member of a vulnerable population, such as prisoners, individuals without legal papers, or otherwise exploitable population 2. Does not have WIFI internet access in their home 3. Does not have access to a smartphone

Study Requirements

The sponsor will send the device to the subject and provide training on the ZASH app. After the subject's first night using the device, they will complete a follow-up visit phone call/office visit where they will complete a questionnaire at the following intervals: 7 day 30-day 60-day 90-day After the 90-day follow up, the subject will return the device with the return label provided by the sponsor.