Pilot Study of Acute Stroke Using the Brainpulse™

Stroke, Acute Clinical Trial

Official title:

Non-Blinded Data Collection Pilot Study of Acute Stroke Using the Brainpulse™

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03235271
• Other study ID #: JMC-1701
• Status: Recruiting
• Start date: September 10, 2017
• Est. completion date: April 1, 2024

Study information

• Verified date: August 2023
• Source: Jan Medical, Inc.
• Contact: Natalie Wright
• Phone: 650-316-8811
• Email: nwright[@]janmedical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: April 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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 < 48 hours prior to enrollment

5. Verbal assent obtained from the subject or LAR, with written consent to be obtained within 72 hours of the initial BrainPulse recording (not applicable to sites where a waiver of consent was granted by IRB)

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. 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.

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

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.

Locations

Country	Name	City	State
United States	University of Cincinnati, Department of Emergency Medicine	Cincinnati	Ohio
United States	NorthShore University Health System	Evanston	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Jan Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Compare Ischemic stroke subject recordings with hemorrhagic stroke subject recordings	BrainPulse signal will be analyzed to compare the similarity and difference of the BrainPulse signal between hemorrhagic stroke and ischemic stroke subjects.	12 months