Detection of hEad Pulse for Ischemic StrOke Verification Study

Stroke, Acute Clinical Trial

— EPISODE_VS  

Official title:

EPISODE-VS: hEad Pulse for Ischemic StrOke Verification Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05602740
• Other study ID #: EPISODE_VS
• Status: Enrolling by invitation
• 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
• 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
• 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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Acute

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