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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05602740
Other study ID # EPISODE_VS
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 15, 2023
Est. completion date October 1, 2023

Study information

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

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 500
Est. completion date October 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Harmony
Passive recording of the head pulse

Locations

Country Name City State
United States Wayne Health Detroit Michigan

Sponsors (2)

Lead Sponsor Collaborator
MindRhythm, Inc. Wayne State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Smith WS, Keenan KJ, Lovoi PA. A Unique Signature of Cardiac-Induced Cranial Forces During Acute Large Vessel Stroke and Development of a Predictive Model. Neurocrit Care. 2020 Aug;33(1):58-63. doi: 10.1007/s12028-019-00845-x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The primary effectiveness objective is to estimate the sensitivity and specificity of LVO diagnosis with Harmony®. 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). Through study completion, an average of 6 months
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