EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic ( EPISODEPSCOVID ) (EPISODE-PH-COV)
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ClinicalTrials.gov Identifier: NCT04445493 |
Recruitment Status :
Recruiting
First Posted : June 24, 2020
Last Update Posted : August 2, 2022
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Condition or disease | Intervention/treatment |
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Stroke, Acute COVID-19 | Device: MindRhythm Harmony |
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 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 |
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Device: MindRhythm Harmony
Passive recording of the head pulse
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Device: MindRhythm Harmony
Passive recording of the head pulse
Other Name: Cranial Accelerometry |
- Prevalence of COVID-19 infection in suspected stroke population [ Time Frame: Through Study Completion, an average of 6 months ]
- 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

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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 |
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

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): NCT04445493
Contact: Lisa Distenfield | 954-552-4206 | lisa.distenfield@mindrhythm.com | |
Contact: Paul Lovoi, Ph.D | 408-230-6396 | paul.lovoi@mindrhythm.com |
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 |
Principal Investigator: | James Paxton, MD | Wayne State University |
Responsible Party: | MindRhythm, Inc. |
ClinicalTrials.gov 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Stroke Ischemic Stroke COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia 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 |