Pilot Study of Acute Stroke Using the Brainpulse™

Completed

• Conditions: Stroke, Acute
• Interventions: Device: BrainPulse Device

• Registration Number: NCT03235271
• Lead Sponsor: Jan Medical, Inc.

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.

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.

Study Timeline

• Study First Submitted: 2017-07-28
• Study First Submitted QC: 2017-07-28
• Study First Posted: 2017-08-01
• Study Start: 2017-09-10
• Primary Completion: 2024-08-28
• Study Completion: 2024-08-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

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 (n/a for Group D2)

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

   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 (n/a for Group D2)

5. Consent procedures followed per applicable IRB approvals at site

Exclusion Criteria

1. Not a candidate for radiological imaging (CT/MR) or angiography (CTA/MRA/DSA) (n/a for 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 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A: Large-Vessel Ischemic Stroked	BrainPulse Device	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.
Group B: Hemorrhagic Stroke	BrainPulse Device	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.
Group C: Transient Ischemic Attack	BrainPulse Device	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.
Group D: Non-Stroke Subjects	BrainPulse Device	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.

Primary Outcome Measures

Name	Time	Method
Compare Stroke subject recordings with non-stroke subject recordings	6 months	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.
Compare differences in signal charactertistics between LVO stroke and all other subjects	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Compare Ischemic stroke subject recordings with hemorrhagic stroke or stroke mimic subject recordings	12 months	BrainPulse signal will be analyzed to compare the similarity and difference of the BrainPulse signal between hemorrhagic stroke, ischemic stroke subjects or stroke mimics.

Trial Locations

Locations (3)

Northwest Community Healthcare; 🇺🇸 Arlington Heights, Illinois, United States

NorthShore University Health System; 🇺🇸 Evanston, Illinois, United States

University of Cincinnati, Department of Emergency Medicine; 🇺🇸 Cincinnati, Ohio, United States