Pilot Study of Acute Stroke Using the Brainpulse™

Last updated: March 4, 2025
Sponsor: Jan Medical, Inc.
Overall Status: Completed

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

BrainPulse Device

Clinical Study ID

NCT03235271
JMC-1701
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female subjects 18 years or older

  2. Patient undergoes or will undergo radiological imaging (CT/MR) as part of strokeevaluation (n/a for Group D2)

  3. Demonstrated at least 1 of the following symptoms (n/a for Group D2):

  4. Hemiparesis, monoparesis, or quadriparesis

  5. Hemisensory deficits

  6. Monocular/binocular visual loss

  7. Visual field deficits

  8. Diplopia

  9. Dysarthria

  10. Facial droop

  11. Ataxia

  12. Vertigo

  13. Aphasia

  14. Severe and sudden onset of headache

  15. Nausea, and/or vomiting

  16. Dizziness

  17. Altered or loss of consciousness

  18. Imbalance/ Incoordination

  19. Last known normal or actual time point, whichever is known, since commencement ofsymptoms < 48 hours prior to enrollment (n/a for Group D2)

  20. Consent procedures followed per applicable IRB approvals at site

Exclusion

Exclusion Criteria:

  1. Not a candidate for radiological imaging (CT/MR) or angiography (CTA/MRA/DSA) (n/afor Group D2)

  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 thatwould impede use of the BrainPulse device

  4. Any serious medical, social or psychological condition that in the opinion of theinvestigator 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 ofenrollment

  8. If does not satisfy the eligibility criteria for groups A, B, C, and D.

Study Design

Total Participants: 252
Treatment Group(s): 1
Primary Treatment: BrainPulse Device
Phase:
Study Start date:
September 10, 2017
Estimated Completion Date:
August 28, 2024

Study 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.

Connect with a study center

  • Northwest Community Healthcare

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • NorthShore University Health System

    Evanston, Illinois 60201
    United States

    Site Not Available

  • University of Cincinnati, Department of Emergency Medicine

    Cincinnati, Ohio 45267-0769
    United States

    Site Not Available

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