Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT05669456
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.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05669456
Study Brief:
Protocol Section:
NCT05669456