Neuralert wrist monitor for continuous stroke detection after high-risk cardiac or vascular surgery
Neuralert Stroke Monitor Trial
This project will try a non-invasive wrist-worn Neuralert monitor that watches for arm asymmetry to help detect stroke sooner in adults at high risk after cardiothoracic or vascular procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Neuralert Technologies LLC Industry-sponsored |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07362303 on ClinicalTrials.gov |
What this trial studies
The Neuralert system is a non-invasive device worn on each wrist that continuously monitors limb movement and looks for asymmetry that may signal a stroke. The study will enroll adults admitted to cardiothoracic or vascular surgery services and compare device performance against a low-information baseline alert rate, aiming for fewer than 2 false alarms per patient per day and materially higher stroke sensitivity than random alerts. Safety and effectiveness endpoints will be collected during hospital stays with continuous monitoring and event adjudication. The trial is conducted at a single academic hospital and focuses on perioperative high-risk patients.
Who should consider this trial
Good fit: Adults aged 22 years or older who are admitted or planned for admission to the participating hospital and are followed by the Cardiothoracic or Vascular Surgery services and considered at high risk for stroke because of high-risk procedures or risk factors (for example age ≥80, prior stroke/TIA, hypercoagulable state, or severely reduced ejection fraction).
Not a fit: Patients who are not at high perioperative stroke risk, are not admitted to the participating hospital, or cannot wear wrist devices may not receive benefit from this monitoring approach.
Why it matters
Potential benefit: If successful, the device could enable earlier recognition of in-hospital strokes, prompt treatment, and potentially reduce disability for high-risk surgical patients.
How similar studies have performed: Proof-of-concept work on wearable movement-monitoring for stroke detection exists and shows promise, but large-scale clinical evidence for wrist-worn asymmetry monitors remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: (all must be yes)
1. Male or female age ≥ 22 years
2. Admitted or planned admission to one of the participating hospitals and followed by the Cardiothoracic (CT) Surgery or Vascular Surgery services
3. 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
Exclusion Criteria: (all must be no)
1. Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
2. 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
3. Above the wrist amputation
4. Unwilling to provide informed consent or no legally authorized representative willing to provide consent if the patient is unable
5. Currently imprisoned
Where this trial is running
Philadelphia, Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Brett Cucchiara, MD
- Email: cucchiar@pennmedicine.upenn.edu
- Phone: (215) 662-6738
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.