Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cardiac Surgery Patients
Device: Neuralert Monitor Device to identify upper extremity asymmetry in patients who are high risk for stroke.
  • Device: Neuralert Monitor
    The Neuralert monitoring system, a non-invasive device worn on each wrist, is designed to provide continuous monitoring for asymmetry in the extremities, sending an alert to healthcare workers upon identification, thus expediting recognition of stroke.

Recruiting Locations

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19103
Contact:
Stephanie Cummings
215-995-0238
stephrcummings@gmail.com

More Details

NCT ID
NCT07362303
Status
Recruiting
Sponsor
Neuralert Technologies LLC

Study Contact

Brett Cucchiara, MD
(215) 662-6738
cucchiar@pennmedicine.upenn.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.