Zeit Alert for Stroke at Home (ZASH) Protocol

NCT ID: NCT05669456

Last Updated: 2022-12-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-09-30

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.

Detailed 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.

Conditions

Acute Ischemic Stroke; Ischemic Stroke; Stroke

Keywords

reoccurring; detection

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Halo Alert System

The Halo Alert System consists of an EEG sensor headband and is paired with a data transfer device.

Intervention Type: DEVICE

Eligibility Criteria

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 ictus to enrollment should 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 Criteria

1. Subject is a member of a vulnerable population, such as prisoners, individuals without legal 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 interfere with 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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zeit Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ZM-OP2

Identifier Type: -

Identifier Source: org_study_id