Pilot Study of Acute Stroke Using the Brainpulse™

Jan Medical

Status: Completed

Conditions: Stroke, Acute

Treatments: Device: BrainPulse Device

Study type: Observational

Funder types: Industry

Identifiers

NCT03235271

JMC-1701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

252 participants in 4 patient groups

Group A: Severe Ischemic Stroke

Description:

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.

Treatment:

Device: BrainPulse Device

Group B: Hemorrhagic Stroke

Description:

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.

Treatment:

Device: BrainPulse Device

Group C: Transient Ischemic Attack

Description:

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.

Treatment:

Device: BrainPulse Device

Group D: Non-Stroke Subjects

Description:

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.

Treatment:

Device: BrainPulse Device