Zeit Alert for Stroke at Home (ZASH) Protocol

Last updated: December 19, 2022
Sponsor: Zeit Medical, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Blood Clots

Thrombosis

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT05669456
ZM-OP2
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. Subject is a member of a vulnerable population, such as prisoners, individuals withoutlegal papers, or otherwise exploitable population;
  2. 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 interferewith the normal function of the Halo Alert System;
  3. Does not have WIFI internet access in their home;
  4. Does not have access to a smartphone;
  5. Open traumatic injury on the head;
  6. 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.)

Study Design

Total Participants: 300
Study Start date:
January 01, 2023
Estimated Completion Date:
September 30, 2024

Study Description

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.