Detection of hEad Pulse for Ischemic StrOke Verification Study

• Conditions: Stroke, Acute
• Interventions: Device: Harmony

• Registration Number: NCT05602740
• Lead Sponsor: MindRhythm, Inc.

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.

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 Timeline

• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-11-02
• Status Verified: 2023-06
• Study Start: 2023-06-15
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-28
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MINDRHYTHM HARMONY	Harmony	Passive Recording of the head pulse

Primary Outcome Measures

Name	Time	Method
The primary effectiveness objective is to estimate the sensitivity and specificity of LVO diagnosis with Harmony®.	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).

Trial Locations

Locations (1)

Wayne Health; 🇺🇸 Detroit, Michigan, United States