EPISODE_VS: hEad Pulse for Ischemic StrOke Verification Study

• Sponsor: MindRhythm, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05602740
• Collaborator: Wayne State University (Other)
• Enrollment: 500
• Anticipated Duration (Months): 3.9

Study Details

Study Description

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 help prehospital providers better identify large vessel stroke patients.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute	Device: Harmony

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. This may help aid in the triage decision of destination hospital for possible stroke patients.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: EPISODE-VS: hEad Pulse for Ischemic StrOke Verification Study
• Anticipated Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
MINDRHYTHM HARMONY Passive Recording of the head pulse	Device: Harmony; Passive recording of the head pulse

Outcome Measures

Primary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• MindRhythm, Inc.
• Wayne State University

Investigators

• Principal Investigator: James Paxton, MD, Wayne State University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: MindRhythm, Inc.
• ClinicalTrials.gov Identifier: NCT05602740
• Other Study ID Numbers: EPISODE_VS
• First Posted: Nov 2, 2022
• Last Update Posted: Nov 2, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Stroke; Ischemic Stroke

Study Results

No Results Posted as of Nov 2, 2022