Wearable device to detect stroke onset

Stroke Alarm Efficacy Trial

This study is testing a wearable device to see if it can quickly detect the start of a stroke in people who have arm weakness.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Region Skane (other)
• Locations: 5 sites (Gothenburg and 4 other locations)
• Trial ID: NCT06315192 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of the Stroke Alarm, a CE-marked wearable device, in identifying the onset of stroke characterized by unilateral arm motor deficit within three hours. It is a multicenter, prospective observational trial involving 500 patients who will wear the device continuously for three months. Data will be collected at baseline, three months post-inclusion, and through national registry data to assess the device's performance in detecting stroke events. The study will also include a propensity-matched control group for comparison.

Who should consider this trial

Good fit: Ideal candidates are patients aged 50 years or older with a recent diagnosis of stroke, TIA, or atrial fibrillation.

Not a fit: Patients with no history of stroke or those who do not meet the inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this device could significantly improve early detection of strokes, leading to timely treatment and better patient outcomes.

How similar studies have performed: While similar wearable devices have been explored, this specific approach using the Stroke Alarm is novel and has not been extensively tested in prior studies.

Eligibility criteria

INCLUSION CRITERIA

1. Age 50 years or older
2. Modified Rankin scale of 0-2.
3. Diagnosed with either:

   A. Recent\* transient ischemic attack (TIA, G45.9), AND:
   * ABCD2 score of ≥6, OR:
   * Atrial fibrillation OR:
   * Large artery atherosclerosis\*\*.

   B. Recent\* acute ischemic stroke (I63), AND:

   • Atrial fibrillation, OR:
   * Large artery atherosclerosis\*\*. C. Atrial fibrillation/flutter (I48), AND
   * None, or reduced dose of, oral anticoagulation medication\*\*\*, AND
   * CHA2DS2-VASC score ≥4.

   D. Recent\* intracerebral hemorrhage (I61.9), AND:

   • Atrial fibrillation.
4. The patient has received the required information about the study and agrees in writing to participate.
5. Smartphone user since at least 1 year.

   * Within the last 2 weeks \*\*Atherosclerosis in carotid, vertebral aortic arch or major intracerebral arteries according to CTA or ultrasound.

     * Including all oral anticoagulation medication such as Warfarin and NOACs. Patients with reduced dose of a NOAC can be included, regardless if this is within the approved label, or if reduced dose is chosen off-label for other reasons. Treatment with antiplatelet medication is permissible.

EXCLUSION CRITERIA

1. Previous inclusion in this study.
2. Arm motor deficit from any previous medical condition.
3. Unable to give informed consent to participate in the study.
4. Does not master any of the languages available within the Stroke Alarm smartphone app in speech and writing.
5. Does not have access to a Stroke Alarm compatible smartphone.
6. Deemed unable to handle the Stroke Alarm smartphone app, or participate in planned follow-up within the framework of the study due to other diseases or circumstances.
7. Does not want to participate.

Where this trial is running

Gothenburg and 4 other locations

• Sahlgrenska University Hospital — Gothenburg, Sweden (NOT_YET_RECRUITING)
• Hässleholms sjukhus — Hässleholm, Sweden (RECRUITING)
• Karolinska University Hospital Huddinge — Huddinge, Sweden (NOT_YET_RECRUITING)
• Skane University hospital — Lund, Sweden (RECRUITING)
• Skåne University Hospital Malmö — Malmö, Sweden (RECRUITING)

Study contacts

• Study coordinator: Magnus Esbjörnsson, MD

Conditions: Stroke Acute, Atrial Fibrillation, TIA, Stroke, wearable, indication, sensor