StrokeNCT06368193
The Neuralert Stroke Monitor Pilot Trial
A study testing Neuralert Monitor in people with Stroke and Surgery, run by Neuralert Technologies LLC at 1 site in United States.
Trial summary
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. 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
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2024to 1 May 2027
- 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
None listed.
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, 19104
Stephanie Cummings, 215-662-3363, stephanie.cummings@pennmedicine.upenn.edu
Brett Cucchiara, MD
About this study
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.
- 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
Device to identify upper extremity asymmetry in patients who are high risk for stroke.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Surgery Patients OR Neurology Patients | Experimental | Not described Receives: Device: Neuralert Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Nursing Response
The time from the nurse receiving an alert to the time they respond after assessing the patient.
Measured: Up to 5 days post patient surgery
Time to Generate Alert
The time to successful generation of an alert to staff when asymmetry or low battery is detected.
Measured: Up to 5 days post patient surgery
Secondary outcomes (2)
Number of Strokes Identified
The number of strokes identified by the Neuralert device and the number of strokes identified by usual care. If a stroke is identified at the next clinical evaluation after an alarm occurs, it will be considered to have been detected by the Neuralert device.
Measured: Up to 5 days post patient surgery
Device Tolerability
The tolerability and impact on clinical workflow and patient feedback on tolerability after study completion.
Measured: Up to 5 days post patient surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start12 Dec 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2027 (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 StrokeStudies 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
- 50 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
- NCT06368193
- Sponsor's protocol ID
- Neuralert 001
- Status last verified
- Jan 2026
- First submitted
- 5 Apr 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neuralert Stroke Monitor Pilot Trial
- ClinicalTrials.gov ID
- NCT06368193
- Acronym / sponsor ID
- Neuralert 001
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Neuralert Technologies LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 16 Apr 2024 (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.
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.
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 OR Neurology Patients | Experimental | Device: Neuralert Monitor |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
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 MonitorDevice to identify upper extremity asymmetry in patients who are high risk for stroke. | Device | Cardiac Surgery Patients OR Neurology Patients |
Primary outcome
Time to Nursing Response
Time frame: Up to 5 days post patient surgery
The time from the nurse receiving an alert to the time they respond after assessing the patient.
Time to Generate Alert
Time frame: Up to 5 days post patient surgery
The time to successful generation of an alert to staff when asymmetry or low battery is detected.
2 secondary outcomes
Number of Strokes Identified
Time frame: Up to 5 days post patient surgery
Device Tolerability
Time frame: Up to 5 days post patient surgery
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 20 Jan 2026.
- Results publication: 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.
- Individual participant dataSharing planned: No
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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 Stroke and Surgery, 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 0 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 20 Jan 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?
Time to Nursing Response (time frame: Up to 5 days post patient surgery). 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 NCT06368193, 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 20 Jan 2026.