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Clinical Trial Summary

The aim of this pilot study is to collect data on stroke patients using the BrainPulse Stroke Monitor. Patient characteristics, diagnostic procedures and clinical outcomes will be documented as part of the data collected to assess the clinical utility of the BrainPulse device. All eligible patients will be enrolled and assigned to a study Group based on confirmation of their diagnosis: Acute Ischemic Stroke, Hemorrhagic Stroke, Transient Ischemic Attack or No Stroke. The data collected from the BrainPulse will be compared across the four different study groups in an attempt to distinguish stroke from other non-stroke conditions that present with similar symptoms. Further assessments will also be made to evaluate if the BrainPulse can distinguish between hemorrhagic and ischemic stroke.


Clinical Trial Description

The study is a prospective, non-randomized, non-blinded, hospital-based study of patients presenting with acute stroke symptoms within 24 hours of symptom onset (last known normal or actual time) as evidenced by radiological imaging. The study will be executed in two parts: Study Part I and Study Part II. Each study part will consist of the same sequence of events and study procedures. The first part of the study is designed to enroll a smaller sample size to evaluate the feasibility of incorporating the BrainPulse device in the Stroke patient care workflow. Patients will be consecutively recruited and once patients have consented and met eligibility, they will be assigned to one of the four study Groups based on their confirmed clinical diagnosis. Each subject will complete one BrainPulse recording before neuro-intervention and within one hour of IV pharmacologic intervention. All subjects will also complete comprehensive neurological, cognitive and NIH Stroke Scale (NIHSS) assessments. Additionally, Ischemic Stroke subjects (Group A) that receive neuro-intervention will complete one BrainPulse recording within four hours after intervention along with a neurological exam. If these procedures have been completed as part of standard of care, the data can be captured directly from the medical records. If such procedures were not conducted as part of hospital's standard of care, they will need to be completed for the purpose of the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03235271
Study type Observational
Source Jan Medical, Inc.
Contact Natalie Wright
Phone 650-316-8811
Email nwright@janmedical.com
Status Recruiting
Phase
Start date September 10, 2017
Completion date April 1, 2024

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