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Wearable bracelet could alert stroke patients within 3 hours

NCT ID NCT06315192

Diagnosis Sponsor: Region Skane Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This trial tests a wearable bracelet called Stroke Alarm that detects when a stroke causes arm weakness. People aged 50 and older with certain high-risk conditions (like recent mini-stroke, atrial fibrillation, or artery disease) wear the device for 3 months. The goal is to see if the alarm can alert patients and caregivers within 3 hours of stroke onset, helping them get to the hospital faster. The study compares results to a similar group from a national stroke registry.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Stroke Alarm wearable bracelets
What this could lead to
If effective, this device could help people with high stroke risk get treated faster, potentially reducing brain damage and disability.
What could go wrong
This is an early-stage trial with 500 participants, and the device may not detect all strokes or could give false alarms. Results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation intracerebral hemorrhage ischemic stroke stroke disorder transient ischemic attack

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation Stroke, acute TIA

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Helsingborg lasarett

    RECRUITING

    Helsingborg, Sweden

  • Hässleholms sjukhus

    RECRUITING

    Hässleholm, 28138, Sweden

  • Karolinska Sjukhuset

    RECRUITING

    Stockholm, Sweden

  • Karolinska University Hospital Huddinge

    RECRUITING

    Huddinge, 14186, Sweden

  • Linköping university hospital

    RECRUITING

    Linköping, Sweden

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, Sweden

  • Skane University hospital

    RECRUITING

    Lund, 22185, Sweden

  • Skåne University Hospital Malmö

    RECRUITING

    Malmö, 20502, Sweden

  • Södersjukhuset

    RECRUITING

    Stockholm, Sweden

  • Uppsala University hospital

    RECRUITING

    Uppsala, Sweden

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