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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05719272
Other study ID # EPISODE_LVO_MR1
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date November 16, 2024
Est. completion date May 30, 2025

Study information

Verified date July 2023
Source MindRhythm, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Acute ischemic stroke (AIS) is a treatable disease if patients can be transported and treated at stroke centers. MindRhythm, Inc (sponsor) has developed an investigational medical device that is designed for prehospital field use to differentiate the two major forms of acute ischemic stroke, namely Large Vessel Occlusion (LVO) stroke and non-large vessel occlusion stroke. The intended use is for paramedics to decide which destination hospital is best for the patient based on the device result. Large vessel occlusion stroke patients should be brought directly to comprehensive stroke centers which can perform thrombectomy, and non-large vessel occlusion stroke should be brought to primary stroke centers. Use of the device will save time getting the patient to thrombectomy and all others to intravenous thrombolytics or blood thinners that clear clots improves outcomes for all patients. The Harmony 5000 device manufactured by MindRhythm has been tested in the pre-hospital environment, but because large vessel occlusion stroke is less common than non-large vessel occlusion stroke, the sponsor wants to obtain additional recordings from patients with large vessel occlusion to better refine their algorithms. Investigators will perform acute recordings on patients who arrive at the medical center who have computed tomography angiography studies showing the presence of large vessel occlusion stroke stroke, and on patients transferred to the angiography suite for thrombectomy. Recordings are performed in parallel to standard workflow of large vessel occlusion stroke patients so the research will not delay treatments.


Description:

Eligible participants will be 18 years of age plus with known large vessel occlusion who have been transferred to the emergency department. Recordings can be made just prior to the thrombectomy or within 2 hours of computed tomography angiography and no thrombectomy performed. Participants will be excluded if they have an open wound on the scalp or are prisoners. The MindRhythm Harmony headset will be placed on the subject (a total of 50 subjects) along with ECG leads and a 3 minute recording of the HeadPulse (cranial waveform) will be performed while the subject remains as still as possible. The data will then be transferred to MindRhythm for analysis and ultimate improvement of the diagnostic stroke algorithm.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 50
Est. completion date May 30, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adult patient Known LVO (transferred or arrived at our ED) ICA-T, M1, M2 or Basilar Artery Recording can be made just prior to thrombectomy, or within 2 hours of CTA and no thrombectomy performed Exclusion Criteria: - Prisoner Open scalp wound

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University at Buffalo Buffalo New York
United States Cooper University Hospital Camden New Jersey

Sponsors (3)

Lead Sponsor Collaborator
MindRhythm, Inc. The Cooper Health System, University at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary HeadPulse Waveform Data Waveform data associated with the changes in brain function as a result of the cranial effect of the. cardiac cycle 90 seconds
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