NCT03235271

Pilot Study of Acute Stroke Using the Brainpulse™

Non-Blinded Data Collection Pilot Study of Acute Stroke Using the Brainpulse™

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 252 (actual)
• Sponsor: Jan Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this pilot study is to collect data on stroke patients and non-stroke patients or healthy volunteers using the BrainPulse Stroke Monitor. Subject 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 and healthy volunteers 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 different study groups in an attempt to distinguish stroke from other non-stroke conditions that present with similar symptoms and LVO from non-LVO types of strokes. Further assessments will also be made to evaluate if the BrainPulse can identify the presence of stroke.

Detailed description

The study is a prospective, non-randomized, non-blinded, hospital-based study of patients presenting with acute stroke symptoms within 48 hours of symptom onset (last known normal or actual time) as evidenced by radiological imaging. The study will be executed in two parts: Study Phase I and Study Phase II. Each study phase 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 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 four hours 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 additional, and optional BrainPulse recording along with a neurological exam after intervention. 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.

Conditions

• Stroke, Acute

Interventions

Type	Name	Description
DEVICE	BrainPulse Device	The BrainPulse is used on a patient's head to non-invasively detect, amplify and capture the skull motion caused by pulsatile cerebral blood flow from the cardiac cycle. The BrainPulse consists of a reusable headset that contains the accelerometers used to measure motion caused by pulsatile cerebral blood flow. The system is powered by a rechargeable battery pack. The headset is placed on the subject's head and outputs data to a data collector that forwards the data to the computer. Each accelerometer has an attached tip that makes contact with the subject's head through hair. The headset also includes a photoplethysmograph (PPG) that simultaneously captures the subject's heart-rate information. There is no energy delivered to the brain or subject by these highly sensitive sensors.

Timeline

• Start date: 2017-09-10
• Primary completion: 2024-08-28
• Completion: 2024-08-28
• First posted: 2017-08-01
• Last updated: 2025-03-07

Locations

3 sites across 1 country: United States