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NCT Number: NCT07362303

Neuralert Stroke Monitor Trial

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.

Recruiting

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19103, United States

Location status: Recruiting

Location contact

Stephanie Cummings

CONTACT

[email protected]

215-995-0238

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuralert Monitor

Device

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 outcomes

  1. Efficacy of Device

    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

  2. Safety of Device

    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.

Secondary outcomes

  1. Length of time to detection of any stroke

    Time frame: through study completion, an average of 2 years

    Time from last known normal to detection of any stroke with weakness

  2. Length of time to detection of stroke by Neuralert

    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

  3. Number of alerts caused by stroke (PPV)

    Time frame: through study completion, an average of 2 years

    How often an alert is caused by confirmed stroke

Other outcomes

  1. Number and type of causes of false alarms

    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

  2. Sensitivity of device

    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

  3. Number of care visits

    Time frame: through study completion, an average of 2 years

    Number of usual care visits documented in the electronic health record

  4. Number and type of adverse events

    Time frame: through study completion, an average of 2 years

    Any adverse events collected during the study

Study contacts

Contact information is provided by the study sponsor or research team.

Brett Cucchiara, MD

CONTACT

[email protected]

(215) 662-6738

Sponsors and collaborators

Lead sponsor

Neuralert Technologies LLC

Industry

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 23, 2026
Registry last updated
Apr 1, 2026

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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