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Pilot Study of Acute Stroke Using the Brainpulse™

This study is not yet open for participant recruitment.
Verified August 2017 by Jan Medical, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03235271
First Posted: August 1, 2017
Last Update Posted: August 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jan Medical, Inc.
  Purpose
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.

Condition Intervention
Stroke, Acute Device: BrainPulse Device

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Blinded Data Collection Pilot Study of Acute Stroke Using the Brainpulse™

Further study details as provided by Jan Medical, Inc.:

Primary Outcome Measures:
  • Compare Stroke subject recordings with non-stroke subject recordings [ Time Frame: 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.


Secondary Outcome Measures:
  • Compare Ischemic stroke subject recordings with hemorrhagic stroke subject recordings [ Time Frame: 12 months ]
    BrainPulse signal will be analyzed to compare the similarity and difference of the BrainPulse signal between hemorrhagic stroke and ischemic stroke subjects.


Estimated Enrollment: 140
Anticipated Study Start Date: August 10, 2017
Estimated Study Completion Date: May 1, 2018
Estimated Primary Completion Date: February 10, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study is expected to enroll up to 140 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, 100 subjects are expected to be enrolled, of which 20 participants will be assigned to Group A, 20 participants assigned to Group B, 20 participants assigned to Group C, 25 participants assigned to Group D and up to 15 screen failures.
Criteria

Inclusion Criteria:

  • 1. Male or female subjects between 18 and 89 years of age 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 < 24 hours prior to enrollment 5. Signed informed consent, and/or have a legally authorized representative willing to provide informed consent on behalf of the subject

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. Prior history of stroke 7. Any neuro-intervention commenced or completed between admission and time of enrollment 8. If all planned radiological imaging (CT and/or MR) and angiography (CTA, MRA or DSA) are complete, does not satisfy the eligibility criteria for groups A, B, C, and D.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235271


Contacts
Contact: Hiba Lejmi, MD 650-316-8068 hlejmi@janmedical.com

Sponsors and Collaborators
Jan Medical, Inc.
  More Information

Responsible Party: Jan Medical, Inc.
ClinicalTrials.gov Identifier: NCT03235271     History of Changes
Other Study ID Numbers: JMC-1702
First Submitted: July 28, 2017
First Posted: August 1, 2017
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases