The Neuralert Stroke Monitor Pilot Trial

Neuralert Technologies LLC

Status: Enrolling

Conditions: Stroke; Surgery

Treatments: Device: Neuralert Monitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT06368193

Neuralert 001

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Cardiac Surgery Patients OR Neurology Patients

Experimental group

Treatment:

Device: Neuralert Monitor