Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19103, United States
Location status: Recruiting
NCT Number: NCT07362303
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.
Interested in participating?
Request Info22 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19103, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(all must be yes)
Exclusion criteria
(all must be no)
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.
Time frame: through study completion, an average of 2 years
To show that the sensitivity of the Neuralert Monitor exceeds the specified performance goal, and
Time frame: through study completion, an average of 2 years
To show that the mean number of false alarms/patient/day for the Neuralert Monitor is less than the specified performance goal.
Time frame: through study completion, an average of 2 years
Time from last known normal to detection of any stroke with weakness
Time frame: through study completion, an average of 2 years
Time from last known normal to detection by the Neuralert Monitor of any stroke with weakness
Time frame: through study completion, an average of 2 years
How often an alert is caused by confirmed stroke
Time frame: through study completion, an average of 2 years
A false alarm is defined as any alarm that does not result in a clinical diagnosis of stroke after the next evaluation by the clinical team
Time frame: through study completion, an average of 2 years
Sensitivity of device for detection of any stroke, regardless of whether the stroke includes asymmetric weakness
Time frame: through study completion, an average of 2 years
Number of usual care visits documented in the electronic health record
Time frame: through study completion, an average of 2 years
Any adverse events collected during the study
Contact information is provided by the study sponsor or research team.
Neuralert Technologies LLC
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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