RECRUITING

The Neuralert Stroke Monitor Pilot Trial

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Neuralert Stroke Monitor Pilot Trial

Quick Facts

Study Start:2024-11-10

Study Completion:2027-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06368193

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Scott Kasner, MD

CONTACT

215-662-3564

scott.kasner@pennmedicine.upenn.edu

Study Locations (Sites)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Neuralert Technologies LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-10

Study Completion Date2027-05-01

Study Record Updates

Study Start Date2024-11-10

Study Completion Date2027-05-01

Terms related to this study

Additional Relevant MeSH Terms

Stroke
Surgery