SurgeryNCT07362303
Neuralert Stroke Monitor Trial
A study testing Neuralert Monitor in people with Surgery and Stroke, run by Neuralert Technologies LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- What is being tested?
- Neuralert Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2026to 15 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19103
Stephanie Cummings, 215-995-0238, stephrcummings@gmail.com
About this study
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.
- Being tested
- Neuralert Monitor
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuralert MonitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Surgery Patients | Experimental | Device: Neuralert Monitor Device to identify upper extremity asymmetry in patients who are high risk for stroke. Receives: Device: Neuralert Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Device
To show that the sensitivity of the Neuralert Monitor exceeds the specified performance goal, and
Measured: through study completion, an average of 2 years
Safety of Device
To show that the mean number of false alarms/patient/day for the Neuralert Monitor is less than the specified performance goal.
Measured: through study completion, an average of 2 years
Secondary outcomes (3)
Length of time to detection of any stroke
Time from last known normal to detection of any stroke with weakness
Measured: through study completion, an average of 2 years
Length of time to detection of stroke by Neuralert
Time from last known normal to detection by the Neuralert Monitor of any stroke with weakness
Measured: through study completion, an average of 2 years
Number of alerts caused by stroke (PPV)
How often an alert is caused by confirmed stroke
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start26 Mar 2026
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuralert Technologies LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362303
- Sponsor's protocol ID
- 859883
- Status last verified
- Mar 2026
- First submitted
- 8 Dec 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36718858
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuralert Stroke Monitor Trial
- ClinicalTrials.gov ID
- NCT07362303
- Acronym / sponsor ID
- 859883
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Neuralert Technologies LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Jul 2028 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Surgery Patients | Experimental | Device: Neuralert MonitorDevice: Neuralert Monitor Device to identify upper extremity asymmetry in patients who are high risk for stroke. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuralert MonitorThe 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. | Device | Cardiac Surgery Patients |
Primary outcome
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
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.
3 secondary outcomes
Length of time to detection of any stroke
Time frame: through study completion, an average of 2 years
Length of time to detection of stroke by Neuralert
Time frame: through study completion, an average of 2 years
Number of alerts caused by stroke (PPV)
Time frame: through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Background: PubMed 36718858Messe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuralert Monitor in people with Surgery and Stroke, run by Neuralert Technologies LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brett Cucchiara, MD ((215) 662-6738, cucchiar@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Device (time frame: through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07362303, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.