Recruiting

Neuralert Monitor

Sponsor:

Neuralert Technologies LLC

Code:

NCT07362303

Conditions

Surgery

Stroke

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Neuralert Monitor

Study Details

Brief summary:

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

Surgery

Stroke

Study ID

NCT07362303

Start date

Mar 26, 2026

Status verified date

Mar, 2026

Completion date

Jul 15, 2028

Anticipated

Primary completion date

Jan 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Enrollment

1200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Cardiac Surgery Patients

Device: Neuralert Monitor Device to identify upper extremity asymmetry in patients who are high risk for stroke.

Interventions

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.

Primary outcome measure

  • Efficacy of Device [ Time Frame: through study completion, an average of 2 years ]
  • Safety of Device [ Time Frame: through study completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

Locations

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19103

Contacts

More Information

Sponsor

Neuralert Technologies LLC

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Neuralert Technologies LLC on 2026-04-01.