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EPISODE-PH-COV: EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic ( EPISODEPSCOVID )

Sponsor
MindRhythm, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04445493
Collaborator
Wayne State University (Other), Western Michigan University (Other)
250
Enrollment
1
Location
21
Anticipated Duration (Months)
11.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prehospital providers encounter patients with suspected stroke frequently. Stroke and COVID-19 are related potentially putting these healthcare workers at risk of COVID-19 infection. In addition, prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers.

Condition or Disease Intervention/Treatment Phase
  • Device: MindRhythm Harmony

Detailed Description

This observational prospective study will document COVID-19 status on patients seen in the prehospital environment for suspected stroke. This will provide an estimate of how frequently stroke occurs in stroke and also the exposure risk to providers in this setting.

Additionally, patients will have a headset placed to record their headpulse during the encounter. These measurements will be used to further develop an analytic model used to predict the presence of large vessel occlusion (LVO) stroke. This may help create a device that can be used in the prehospital environment to aid in the trade decision of destination hospital.

Study Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Device: MindRhythm Harmony

Passive recording of the head pulse

Device: MindRhythm Harmony
Passive recording of the head pulse
Other Names:
  • Cranial Accelerometry

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of COVID-19 infection in suspected stroke population [Through Study Completion, an average of 6 months]

    2. Quality head pulse recordings [Through Study Completion, an average 6 months]

      Proportion of head pulse studies deemed of high quality for further analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • suspected stroke in the prehospital setting

    • patient at risk for COVID-19

    Exclusion Criteria:

    • scalp laceration

    • Patient refusal

    • Prisoner, other vulnerable population

    • Prehospital provider feels that the recording may interfere with care

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wayne State University Detroit Michigan United States 48201

    Sponsors and Collaborators

    • MindRhythm, Inc.
    • Wayne State University
    • Western Michigan University

    Investigators

    • Principal Investigator: James Paxton, MD, Wayne State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MindRhythm, Inc.
    ClinicalTrials.gov Identifier:
    NCT04445493
    Other Study ID Numbers:
    • EPISODE-PH-COVID
    First Posted:
    Jun 24, 2020
    Last Update Posted:
    Aug 2, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Stroke
    Ischemic Stroke

    Study Results

    No Results Posted as of Aug 2, 2022