Detection of hEad Pulse for Ischemic StrOke Verification Study (EPISODE_VS)

MindRhythm

Status: Invitation-only

Conditions: Stroke, Acute

Treatments: Device: Harmony

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05602740

EPISODE_VS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

MINDRHYTHM HARMONY

Description:

Passive Recording of the head pulse

Treatment:

Device: Harmony