NCT06368193Recruiting
The Neuralert Stroke Monitor Pilot Trial
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
This trial aims to demonstrate that the Neuralert Monitoring System will detect strokes before they would be identified by current standard of care. Each patient will be monitored for up to five days, depending on device connectivity or battery duration. Each monitoring session will consist of wearing a Neuralert device on each arm. For this pilot trial, we are interested in learning about Wi-Fi connectivity, successful data transmission, integration into clinical workflow, usability and tolerability.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 5 Apr 2024
- Start date
- 12 Dec 2024
- Primary completion date
- 1 May 2026
- Lead sponsor
- Neuralert Technologies LLC
- Diseases
- Stroke
- NCT number
- NCT06368193
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 12 Dec 2024 to the primary completion date, 1 May 2026
- 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
Criteria the registry did not label
- 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:
- Ø 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
- Ø Other cardiac procedures along with a high-risk medical history:
- Age ≥ 80 years · Prior stroke/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
- Admitted with a stroke or TIA attributed to large artery occlusion or severe stenosis that has not been revascularized.
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital of the University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.