Wearable device for early stroke detection
StrokeAlarm Trial 2
This study is testing a wearable device that helps people who have had a recent mini-stroke or have atrial fibrillation to see if it can safely detect the early signs of a stroke in everyday life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 1 site (Hässleholm) |
| Trial ID | NCT05144932 on ClinicalTrials.gov |
What this trial studies
This open, multicenter, prospective, single-arm study evaluates the usability and feasibility of a wearable stroke indication system called Stroke Alarm in patients with recent TIA, minor stroke without persistent arm motor deficit, or atrial fibrillation. The study aims to test the safety and feasibility of this CE-marked device, which monitors arm motor function to detect the onset of stroke in real-life situations. Participants will be monitored for adverse events, user compliance, and overall experience with the device. The trial does not include a comparator group and focuses on identifying barriers to use among patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a recent diagnosis of TIA, minor stroke, or newly diagnosed atrial fibrillation.
Not a fit: Patients with significant arm function impairment from previous strokes or other conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could enable earlier detection of strokes, potentially improving patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in wearable technology for health monitoring, but this specific device's efficacy remains untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years or older 2. Patients with 2A. Diagnosed (ICD-10) TIA (G45.9: Transitory ischemic attack or G45.3: Amaurosis fugax, or 2B. ICD-10 ischemic stroke, I63.0-9. 2C. Newly diagnosed atrial fibrillation. 2D. Atrial fibrillation with an increased risk of stroke (contraindication to oral anticoagulants, reduced dose of oral anticoagulants or other risk factors presenting an estimated annual stroke risk of 5% or more despite anticoagulants treatment. 3. Subject has after study specific information consent to participation by signing the Ethics committee-approved inform consent form. Exclusion Criteria: 1. Already included in the study in connection with previous TIA/stroke. 2. Has an affected arm function due to previous stroke or other illness/trauma. 3. Cannot provide informed consent to participation in the study. 4. Does not speak Swedish or English in speech and writing. 5. Assessed due to other diseases or circumstances in general cannot contribute to planned follow-up within the framework of the study. 6. Do not want to participate. 7. During the study period, do not have access to a compatible smartPhone. 8. Not deemed capable of managing the Stroke Alarm smartphone app.
Where this trial is running
Hässleholm
- Hässleholms sjukhus — Hässleholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Magnus Esbjörnsson, MD — Region Skåne
- Study coordinator: Johan Wasselius, MD, PhD
- Email: johan.wasselius@med.lu.se
- Phone: +4646173082
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.