Monitoring strokes with the Neuralert device
The Neuralert Stroke Monitor Pilot Trial
This study tests whether the Neuralert device can help doctors spot strokes earlier in patients at high risk during surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Neuralert Technologies LLC Industry-sponsored |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06368193 on ClinicalTrials.gov |
What this trial studies
This pilot trial evaluates the Neuralert Monitoring System's ability to detect strokes earlier than current standard care. Patients will wear a Neuralert device on each arm for up to five days to monitor their condition. The study focuses on assessing Wi-Fi connectivity, data transmission success, integration into clinical workflows, and the usability and tolerability of the device. The goal is to improve stroke detection in high-risk patients undergoing surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older who are admitted to the Hospital of the University of Pennsylvania and are at high risk for stroke due to specific surgical procedures or medical conditions.
Not a fit: Patients who are not at high risk for stroke or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to earlier detection of strokes, potentially improving patient outcomes and reducing complications.
How similar studies have performed: While this approach is innovative, it is still in the pilot phase, and there is limited data on similar studies demonstrating success.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 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 4. Admitted with a stroke or TIA attributed to large artery occlusion or severe stenosis that has not been revascularized. 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.