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Trial record 3 of 4 for:    MIndRhythm
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Detection of hEad Pulse for Ischemic StrOke Verification Study (EPISODE_VS)

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ClinicalTrials.gov Identifier: NCT05602740
Recruitment Status : Enrolling by invitation
First Posted : November 2, 2022
Last Update Posted : July 28, 2023
Sponsor:
Collaborator:
Wayne State University
Information provided by (Responsible Party):
MindRhythm, Inc.

Study Description
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Brief Summary:
Prehospital providers encounter patients with suspected stroke frequently. Prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers. This device will identify large vessel stroke to ultimately improve triage decisions and optimize outcomes.

Condition or disease Intervention/treatment
Stroke, Acute Device: Harmony

Detailed Description:
Patients suspected of stroke by a prehospital provider will have a headset placed to record their headpulse during the encounter. These measurements will be used to assess the accuracy of the device at predicting the presence of large vessel occlusion (LVO) stroke. The MindRhythm, Inc., Harmony® 5000 device is intended to be used in the pre-hospital setting by medical professionals to diagnose large vessel occlusion stroke in adults suspected of having a stroke.
Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: EPISODE-VS: hEad Pulse for Ischemic StrOke Verification Study
Actual Study Start Date : June 15, 2023
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Groups and Cohorts
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Group/Cohort Intervention/treatment
MINDRHYTHM HARMONY
Passive Recording of the head pulse
 Device: Harmony
Passive recording of the head pulse


Outcome Measures
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Primary Outcome Measures :
  1. The primary effectiveness objective is to estimate the sensitivity and specificity of LVO diagnosis with Harmony®. [ Time Frame: Through study completion, an average of 6 months ]
    The subject's final discharge diagnosis based on the CTA scan and the neurologist's assessment will serve as the "ground truth" diagnosis. The sensitivity and specificity will be estimated as the point estimate (Harmony® identified correctly divided by the ground truth number); the confidence intervals will be estimated by the Clopper-Pearson method (exact intervals for proportions).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients who are being evaluated in the prehospital environment by Paramedics/EMTs in whom stroke is suspected.
Criteria

Inclusion Criteria:

• suspected stroke in the prehospital setting

Exclusion Criteria:

  • scalp laceration
  • Patient refusal
  • Prisoner, other vulnerable population
  • Prehospital provider feels that the recording may interfere with care
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05602740


Locations
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United States, Michigan
Wayne Health
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
MindRhythm, Inc.
Wayne State University
Investigators
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Principal Investigator: James Paxton, MD Wayne State University
More Information
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Publications:

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Responsible Party: MindRhythm, Inc.
ClinicalTrials.gov Identifier: NCT05602740    
Other Study ID Numbers: EPISODE_VS
First Posted: November 2, 2022    Key Record Dates
Last Update Posted: July 28, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases