Pilot Study of Acute Stroke Using the Brainpulse™

NCT03235271 | Completed

• 1 other identifier: JMC-1701
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (2)

• 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

• Compare differences in signal charactertistics between LVO stroke and all other subjects

  BrainPulse signal of all subjects will be analyzed to compare the difference in signal characteristics between LVO stroke and all other subjects enrolled in the study.

  12 months

Secondary Outcomes (1)

• Compare Ischemic stroke subject recordings with hemorrhagic stroke or stroke mimic subject recordings

  12 months

Study Arms (4)

Group A: Severe Ischemic Stroke

Group A will include subjects that present with focal neurological deficits and clinical features consistent with ischemic stroke. Subjects in this group will have a clinical presentation consistent with ischemic stroke and confirmed by radiological imaging. Subjects in this group need to present with an NIHSS score of greater than or equal to 6. Group A is divided into 2 study sub groups of A1 and A2. Group A1 are subjects confirmed with acute ischemic stroke secondary to LVO by imaging. Group A2 are subjects that present with symptoms of acute ischemic stroke and confirmed to not have an LVO ischemic stroke.

Device: BrainPulse Device

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

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

Group D: Non-Stroke Subjects

Group D will include control subjects that do not have an acute stroke. They will be sub-divided into Group D1 and D2. Group D1 subjects will be stroke mimics that present with stroke-like symptoms but do not have a diagnosis of stroke or TIA. In order to qualify for this sub 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. Group D2 subjects will be non-stroke controls that are either patients that present to the hospital for a reason unrelated to stroke and no stroke symptoms or healthy volunteers that are non-clinical visitors or hospital staff. Subjects must have no stroke-like symptoms or suspicion of stroke by the treatment or study team.

Device: BrainPulse Device

Interventions

BrainPulse Device 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 A: Severe Ischemic Stroke; Group B: Hemorrhagic Stroke; Group C: Transient Ischemic Attack; Group D: Non-Stroke Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study is expected to enroll up to 289 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, up to 249 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 D1, and up to 62 participants assigned to group D2, and up to 37 screen failures.

You may qualify if:

• Male or female subjects 18 years or older
• Patient undergoes or will undergo radiological imaging (CT/MR) as part of stroke evaluation (n/a for Group D2)
• Demonstrated at least 1 of the following symptoms (n/a for Group D2):
• Hemiparesis, monoparesis, or quadriparesis
• Hemisensory deficits
• Monocular/binocular visual loss
• Visual field deficits
• Diplopia
• Dysarthria
• Facial droop
• Ataxia
• Vertigo
• Aphasia
• Severe and sudden onset of headache
• Nausea, and/or vomiting

You may not qualify if:

• Not a candidate for radiological imaging (CT/MR) or angiography (CTA/MRA/DSA) (n/a for Group D2)
• Patient meets the hospital criteria for brain death
• Wound or laceration on the head in the area of one of the BrainPulse sensors that would impede use of the BrainPulse device
• Any serious medical, social or psychological condition that in the opinion of the investigator would disqualify a patient from participation
• Symptoms due to head trauma
• IV tPA commenced or completed \> 4 hours ago
• Any neuro-intervention commenced or completed between admission and time of enrollment
• If does not satisfy the eligibility criteria for groups A, B, C, and D.

Sponsors & Collaborators

• Jan Medical, Inc.: lead

Study Sites (3)

Northwest Community Healthcare

Arlington Heights, Illinois, 60005, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

University of Cincinnati, Department of Emergency Medicine

Cincinnati, Ohio, 45267-0769, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kyle Walsh, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 1, 2017
• Study Start: September 10, 2017
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

US (3)