Pilot Study of Acute Stroke Using the Brainpulse™

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Acute
• Intervention / Treatment: Device: BrainPulse Device

Detailed 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 Type: Observational
• Enrollment (Estimated): 220

Contacts and Locations

• Study Contact: Name: Natalie Wright; Phone Number: 650-316-8811; Email: nwright@janmedical.com

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Recruiting
      • NorthShore University Health System
      • Contact: Robert Frech, BS, CCRP
      • Contact: Boris Jancan, MD, CCRP
      • Principal Investigator: Shakeel Chowdhry, MD
      • Sub-Investigator: Archie Ong, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0769
      • Recruiting
      • University of Cincinnati, Department of Emergency Medicine
      • Contact: Stephanie Thomas, M. Ed., CCRP; Phone Number: 513-558-4536; Email: mailto:stephanie.thomas@uc.edu
      • Contact: Cristina Spinner, CCRP; Phone Number: (513) 558-0698; Email: cristina.spinner@uc.edu
      • Principal Investigator: Kyle Walsh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study is expected to enroll up to 220 subjects in total for both parts of the study. During Part I of the study, 40 subjects are expected to be enrolled, of which 20 participants will be assigned to Group A, 5 participants assigned to Group B, 5 participants assigned to Group C, 5 participants assigned to Group D and up to 5 screen failures. In the second part of the study, 180 subjects are expected to be enrolled, of which 57 participants will be assigned to Group A1, 57 participants assigned to Group A2, 36 participants assigned to Group D, and up to 30 screen failures.

Description

Inclusion Criteria:

1. Male or female subjects 18 years or older
2. Patient undergoes or will undergo radiological imaging (CT/MR) as part of stroke evaluation

3. Demonstrated at least 1 of the following symptoms:

   1. Hemiparesis, monoparesis, or quadriparesis
   2. Hemisensory deficits
   3. Monocular/binocular visual loss
   4. Visual field deficits
   5. Diplopia
   6. Dysarthria
   7. Facial droop
   8. Ataxia
   9. Vertigo
   10. Aphasia
   11. Severe and sudden onset of headache
   12. Nausea, and/or vomiting
   13. Dizziness
   14. Altered or loss of consciousness
   15. Imbalance/ Incoordination
4. Last known normal or actual time point, whichever is known, since commencement of symptoms < 48 hours prior to enrollment
5. Verbal assent obtained from the subject or LAR, with written consent to be obtained within 72 hours of the initial BrainPulse recording (not applicable to sites where a waiver of consent was granted by IRB)

Exclusion Criteria:

1. Not a candidate for radiological imaging (CT/MR) or angiography (CTA/MRA/DSA)
2. Patient meets the hospital criteria for brain death
3. Wound or laceration on the head in the area of one of the BrainPulse sensors that would impede use of the BrainPulse device
4. Any serious medical, social or psychological condition that in the opinion of the investigator would disqualify a patient from participation
5. Symptoms due to head trauma
6. IV tPA commenced or completed > 4 hours ago
7. Any neuro-intervention commenced or completed between admission and time of enrollment
8. If does not satisfy the eligibility criteria for groups A, B, C, and D.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A: Large-Vessel Ischemic Stroked; Group A will include subjects that present with focal neurological deficits and clinical features consistent with ischemic stroke with a large vessel occlusion (see Key Terms for definition). Subjects in this group will have a clinical presentation consistent with ischemic stroke and a large vessel occlusion confirmed through angiography. It is common practice to have the CTA completed immediately after CT imaging. Clinical presentation will include classic features of stroke syndromes that occur based on the localization of the infarct, which includes cortical symptoms that can be lateralized to the left side or right side of the brain.	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.
Group B: Hemorrhagic Stroke; Subjects in this group will present with symptoms similar to Group A. In addition, they will present with clinical symptoms consistent of increased intracranial pressure such as nausea, vomiting, loss of consciousness and severe headache. In order for a subject to be eligible, the hemorrhage will be limited to primarily intracerebral hemorrhage with a minimum volume of 10mL. Subarachnoid hemorrhage and intraventricular hemorrhage may also be present as incidental findings. Since it is unlikely that these subjects proceed for neuro-intervention, they will not have a follow-up BrainPulse recording and they will be exited after completing study procedures.	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.
Group C: Transient Ischemic Attack; Subjects in this group will present with focal neurological symptoms consistent with stroke. In order for subjects to be eligible for this group, enrollment will need to be within 6 hours of resolution of symptoms along with a confirmation of TIA by treating team. In addition, initial and follow-up radiological imaging needs to show that there are no signs of ischemic stroke or hemorrhage.	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.
Group D: Non-Stroke Subjects; Subjects in this group will present with stroke-like symptoms but do not have a diagnosis of stroke nor TIA. In order to qualify for this group, subjects will also need to show evidence of no stroke on radiological imaging (CT and/or MRI). Diagnoses in this group may include seizure, systemic infection, brain tumor, metabolic disorder, positional vertigo, hemiplegic migraine, encephalopathy, cranial nerve injury, spinal cord injury, brachial/sacral plexus injury, peripheral nerve injury, etc.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare Stroke subject recordings with non-stroke subject recordings	The primary endpoint in Part I of the study is to enroll and record BrainPulse data from 35 eligible subjects who present with classic stroke symptoms and either have a confirmed diagnosis of stroke or no stroke. The BrainPulse device will be used to analyze and compare the differences in signal characteristics between stroke, TIA and control subjects.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare Ischemic stroke subject recordings with hemorrhagic stroke subject recordings	BrainPulse signal will be analyzed to compare the similarity and difference of the BrainPulse signal between hemorrhagic stroke and ischemic stroke subjects.	12 months

Collaborators and Investigators

• Sponsor: Jan Medical, Inc.
• Investigators: Principal Investigator: Kyle Walsh, MD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2017
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: July 28, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: JMC-1701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No