The Neuralert Stroke Monitor Pilot Trial

Overview

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.

Interventions

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

Primary outcome measures

• 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]

Secondary outcome measures (2)

• Number of Strokes Identified [Time frame: Up to 5 days post patient surgery]
• Device Tolerability [Time frame: Up to 5 days post patient surgery]

Eligibility criteria

• Male or female age ≥ 22 years
• Admitted or planned admission to one of the participating hospitals and followed by the Cardiothoracic (CT) Surgery or Vascular Surgery services
• 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
• 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)

• Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
• 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
• Above the wrist amputation
• Unwilling to provide informed consent or no legally authorized representative willing to provide consent if the patient is unable
• Currently imprisoned

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

United States · 1 center

• Hospital of the University of Pennsylvania — Philadelphia

Publications

• Messe SR, Kasner SE, Cucchiara BL, McGarvey ML, Cummings S, Acker MA, Desai N, Atluri P, Wang GJ, Jackson BM, Weimer J. Derivation and Validation of an Algorithm to Detect Stroke Using Arm Accelerometry Data. J Am Heart Assoc. 2023 Feb 7;12(3):e028819. doi: 10.1161/JAHA.122.028819. Epub 2023 Jan 31. PMID 36718858

Identifiers

NCT: NCT06368193 · Neuralert 001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗