Clinical trial NCT06368193: The Neuralert Stroke Monitor Pilot Trial
Official title: The Neuralert Stroke Monitor Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Stroke
Surgery
Lead sponsor: Neuralert Technologies LLC
Sponsor class: INDUSTRY
First posted: 2024-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 22 years
* Admitted to or planned admission to the Hospital of the University of Pennsylvania and followed by the Cardiothoracic (CT) Surgery or Vascular Surgery services
* Considered at high risk for stroke while in the hospital based on:

  1. Interventions or procedures performed during the hospitalization including: Intracardiac surgical or endovascular procedures including valve replacement, ascending aorta or aortic arch surgical or endovascular repair, and open surgical or endovascular carotid revascularization
  2. Other CT surgery or Vascular surgery procedures in patients with high risk characteristics including: Atrial fibrillation, 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, or age ≥ 80.

Exclusion Criteria:

* 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 asymmetric upper extremity weakness as assessed by the study team at time of enrollment, defined as an NIHSS upper extremity motor score \>0 in either arm.
* A limb amputation above the wrist in the upper extremities
* Unwilling to provide informed consent and no legally authorized representative willing to provide informed consent if the patient is unable

Primary outcomes:
measure: Time to Nursing Response
timeFrame: Up to 5 days post patient surgery
measure: Time to Generate Alert
timeFrame: Up to 5 days post patient surgery
Secondary outcomes:
measure: Number of Strokes Identified
timeFrame: Up to 5 days post patient surgery
measure: Device Tolerability
timeFrame: Up to 5 days post patient surgery
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
citation: 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.