Open Actively Recruiting

Zeit Alert for Stroke at Home (ZASH) Protocol

About

Brief Summary

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.

Study Type
Observational

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • New ischemic stroke confirmed by neuroimaging (CT or MRI scans) as the reason for current hospital admission or stroke clinics visit. Time from ictus to enrollment should be ≤ 2 weeks;
  • RRE-90 > 2;
  • Age ≥ 18 years old;
  • Patient is discharged to home;
  • Provision of signed and dated informed consent form.

Exclusion Criteria:

  • Subject is a member of a vulnerable population, such as prisoners, individuals without legal papers, or otherwise exploitable population;
  • Treatment with another investigational drug or intervention within the last two (2) weeks prior to start of this study, if said drug/intervention is expected to interfere with the normal function of the Halo Alert System;
  • Does not have WIFI internet access in their home;
  • Does not have access to a smartphone;
  • Open traumatic injury on the head;
  • Allergy to any of the components of the headband, such as the fabric of the band (88% Rayon, 9% Nylon, 3% Spandex), the electrode surfaces (conductive silver ink.)

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Study Stats
Protocol No.
22-5130
Category
Brain/Neurological Diseases
Contact
Elizabeth Cruz
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05669456
For detailed technical eligibility, visit ClinicalTrials.gov.