Neuralert Stroke Monitor Trial

Overview

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.

Interventions

• 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.

Primary outcome measures

• 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]

Secondary outcome measures (3)

• Length of time to detection of any stroke [Time frame: through study completion, an average of 2 years]
• Length of time to detection of stroke by Neuralert [Time frame: through study completion, an average of 2 years]
• Number of alerts caused by stroke (PPV) [Time frame: through study completion, an average of 2 years]

Eligibility criteria

Inclusion Criteria: (all must be yes)

• 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:

• 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)

• 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: NCT07362303 · 859883

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗