Zeit Alert for Stroke at Home (ZASH) Protocol

NCT05669456 | Unknown

• 1 other identifier: ZM-OP2
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Ischemic Stroke; Ischemic Stroke; Stroke

Keywords

reoccurring; detection

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Halo Alert System DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Zeit Medical, Inc.: lead

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2022
• First Posted: December 30, 2022
• Study Start: January 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: December 30, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share