Recruiting

Neuralert Monitoring

Sponsor:

Neuralert Technologies LLC

Code:

NCT06368193

Conditions

Stroke

Surgery

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Neuralert Monitor

Study Details

Brief summary:

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.

Conditions

Stroke

Surgery

Study ID

NCT06368193

Start date

Dec 12, 2024

Status verified date

Jan, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Cardiac Surgery Patients OR Neurology Patients

Interventions

Neuralert Monitor

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

Primary outcome measure

  • Time to Nursing Response [ Time Frame: Up to 5 days post patient surgery ]
  • Time to Generate Alert [ Time Frame: Up to 5 days post patient surgery ]

Central Contacts and Locations

Central contacts

Locations

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Brett Cucchiara, MD

More Information

Sponsor

Neuralert Technologies LLC

Last update posted

Jan 20, 2026

Last verified

Jan, 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 2026-01-20.