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NCT07362303Recruiting

Neuralert Stroke Monitor Trial

Source: ClinicalTrials.gov · Last updated 1 Apr 2026

Brief summary (registry, in English)

The Neuralert monitoring system, a non-invasive device worn on each wrist, is designed to provide continuous monitoring and expedited recognition of stroke by identifying asymmetry in the extremities, facilitating patient treatment and improving outcomes. This study is designed to evaluate the safety and effectiveness of the Neuralert Monitor. This study aims to show that the device produces fewer than 2 false alarms per patient per day on average, and that the device detects stroke with a sensitivity significantly greater than a device producing 2 random alerts per day.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1200 (estimated)
First submitted
8 Dec 2025
Start date
26 Mar 2026
Primary completion date
15 Jan 2028
Lead sponsor
Neuralert Technologies LLC
Diseases
Stroke
NCT number
NCT07362303

What you commit to

  • Study type: Interventional
  • Planned participants: 1200
  • From 26 Mar 2026 to the primary completion date, 15 Jan 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study

Other

  • Baseline preoperative asymmetric upper extremity weakness as assessed by the Investigator, defined as a differential in the NIHSS upper extremity motor score between the two arms of \>0
  • Above the wrist amputation
  • Unwilling to provide informed consent or no legally authorized representative willing to provide consent if the patient is unable
  • Currently imprisoned

Who the study is looking for

  • Male or female age ≥ 22 years
  • Admitted or planned admission to one of the participating hospitals and followed by the Cardiothoracic (CT) Surgery or Vascular Surgery services
  • Considered at high risk for stroke while in the hospital based on:
    • Interventions or procedures that are high-risk for stroke performed during the hospitalization, which may include:
    • Intracardiac surgical or endovascular procedures, including valve replacement
    • Ascending aorta or aortic arch surgical or endovascular repair
    • Open surgical or endovascular carotid revascularization
    • Other cardiac procedures along with a high-risk medical history:
    • Age ≥ 80 years
    • Prior stroke/ transient ischemic attack (TIA)
    • Hypercoagulable state (i.e., prior clotting events attributed to active malignancy or a diagnosed thrombophilia) requiring lifelong anticoagulation
    • Severely reduced left ventricular cardiac ejection fraction (i.e., \<30%) or anterior left ventricular wall akinesis
    • Atrial fibrillation

Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital of the University of Pennsylvania
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.