NCT05602740

Detection of hEad Pulse for Ischemic StrOke Verification Study

EPISODE-VS: hEad Pulse for Ischemic StrOke Verification Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: MindRhythm, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Stroke, Acute

Interventions

Type	Name	Description
DEVICE	Harmony	Passive recording of the head pulse

Timeline

• Start date: 2023-06-15
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2022-11-02
• Last updated: 2023-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study