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Trial record 2 of 23 for:    accelerometry | stroke

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04445493
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : August 2, 2022
Wayne State University
Western Michigan University
Information provided by (Responsible Party):
MindRhythm, Inc.

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
Stroke, Acute COVID-19 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.

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Study Type : Observational
Estimated 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 : March 1, 2021
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : December 2022

Group/Cohort Intervention/treatment
Device: MindRhythm Harmony
Passive recording of the head pulse
Device: MindRhythm Harmony
Passive recording of the head pulse
Other Name: Cranial Accelerometry

Primary Outcome Measures :
  1. Prevalence of COVID-19 infection in suspected stroke population [ Time Frame: Through Study Completion, an average of 6 months ]
  2. Quality head pulse recordings [ Time Frame: Through Study Completion, an average 6 months ]
    Proportion of head pulse studies deemed of high quality for further analysis

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are being evaluated in the prehospital environment by Detroit Paramedics/EMTs in whom stroke is suspected and who may be at risk fo COVID-19 infection

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

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 identifier (NCT number): NCT04445493

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Contact: Lisa Distenfield 954-552-4206
Contact: Paul Lovoi, Ph.D 408-230-6396

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United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: James Paxton, MD    313-966-6119      
Contact: Kathy Cross    313-966-6110      
Sponsors and Collaborators
MindRhythm, Inc.
Wayne State University
Western Michigan University
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Principal Investigator: James Paxton, MD Wayne State University
Publications of Results:
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Responsible Party: MindRhythm, Inc. Identifier: NCT04445493    
Other Study ID Numbers: EPISODE-PH-COVID
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: January 2022
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: No
Additional relevant MeSH terms:
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Ischemic Stroke
Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases