Zeit Alert for Stroke at Home (ZASH) Protocol

Stroke Clinical Trial

— ZASH  

Official title:

Zeit Alert for Stroke at Home (ZASH) Protocol

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05669456
• Other study ID #: ZM-OP2
• Status: Not yet recruiting
• Start date: January 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2022
• Source: Zeit Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zeit Medical, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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