The Neuralert Stroke Monitor Pilot Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-12

Study Completion Date

2027-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cardiac Surgery Patients OR Neurology Patients

Group Type EXPERIMENTAL

Neuralert Monitor

Intervention Type DEVICE

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

Interventions

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Neuralert Monitor

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

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No