Study to Test Sensitivity and Specificity of Passive Wave Pressure Device in Determining Ischemic Stroke

A NonRandomized, Multicenter, NonSig Risk Study With a NonInv, Passive PressureWave Method of Diagnosing Cerebral Anomalies to Develop a Diag. Algorithm for Cerebral Isch and to Test Sens./Spec. of This Algorithm in Determining Isch Stroke

That the Jan Medical Nautilus NeuroWaveTM system provides significantly higher sensitivity to hyper acute ischemic stroke than does CT.

Study Overview

• Status: Terminated
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: Nautilus NeuroWaveTM System

Detailed Description

In spite of the fact that approximately 800,000 strokes are diagnosed in the United States each year, many physicians and patients have approached the management of stroke with a sense of futility. However, within the past 2 decades, following the advent of computerized tomography (CT), medical interest has turned toward stroke and effective interventions to treat and prevent it have received attention.

CT and/or magnetic resonance imaging (MRI) are the typical diagnostic tools used in the event of a stroke alert. These studies are done on an emergent or urgent basis, since, to be effective, treatments for ischemic and hemorrhagic stroke must be delivered soon after onset of the illness. In an effort to institute an appropriate therapeutic regime, laboratory and structural diagnostic studies are required to be done as rapidly as possible to determine pathological etiology, size, and location of concern.

The speed at which a diagnosis is made and a treatment plan established often determines patient outcome and any associated complications. This is especially true when evaluating patients for ischemic stroke where there is a narrow 3 hour window of opportunity in which to resolve the clot with IV .before permanent neurological impairment results, and up to 8 additional hours with the use if intra arterial (IA) t-PA or interventional mechanical embolectomy procedures are utilized. Current treatment modalities include pharmacologic thrombolytic drugs utilized to disrupt or dissolve clots located in the distal vasculature or mechanical intervention in larger vessels. Since many patients do not recognize the symptoms of stroke they do not seek medical attention immediately. Significant time is then often lost from the onset of the stroke before seeking medical help / treatment.

Although the current technologies are quite adequate as diagnostic tools for hemorrhagic stroke and for identifying subdural hematomas, and other pooled blood abnormalities which would preclude t-PA therapy, they are largely ineffective at positively identifying stroke during the limited therapeutic window of time. Positive identification of ischemia itself is rarely possible or practical with CT or within the limited therapeutic window. As such the diagnostic determination and associated treatment decisions are based on the unsatisfactory basis of exclusion.

• Study Type: Observational
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center
    • Baltimore, Maryland, United States, 21205-1911
      • Johns Hopkins Hospital
    • Columbia, Maryland, United States, 21044
      • Howard County General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects with stroke symptoms that are being evaluated for stroke or healthy subjects that have no cerebrovascular disease and are not being evaluated for symptoms of stroke.

Description

Inclusion Criteria:

• Symptoms consistent with stroke with known onset < 12 hours prior to enrollment and planned recording with the Nautilus NeuroWave System
• Suspected pathology of following vessels: internal carotid artery, ACA, MCA, PCA, basilar or other anterior or posterior cerebral vessels or normal anatomy
• Subject is planned to undergo standard stroke triage imaging protocol
• Able to understand and provide signed informed consent, or have a Legally Authorized Representative willing to provide informed consent on subject's behalf

Exclusion Criteria:

• Known to meet hospital criteria for brain death
• Not a candidate for CT, MRI
• unknown time of stroke symptom onset.
• Psychologically unstable and not able to cooperate
• Not suitable for participation in this study in the opinion of the Investigator

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with Stroke Symptoms; Suspected stroke subjects that present to hospital with stroke symptoms and are evaluated for stroke	Device: Nautilus NeuroWaveTM System; Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke.
Normal Cohort; Subjects that are not being evaluated for stroke and are confirmed to have no cerebrovascular disease	Device: Nautilus NeuroWaveTM System; Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Device Related Adverse Events	Count the number of participants with device related adverse events	2-3 days, at subject exit (variation of subject exit date depended on when subject obtained their radiology imaging to confirm ischemic stroke)

Secondary Outcome Measures

Outcome Measure	Time Frame
Determine the Location to Left, Right, Deep, and/or Back of the Cranium	At study completion- approximately 8 months
Incidence of Device Related Adverse Events	At study completion- approximately 8 months
Nautilus NeuroWaveTM Recording in MRI Normal Population (no Cerebrovascular Disease Per MRI)	At study completion- approximately 8 months

Collaborators and Investigators

• Sponsor: Jan Medical, Inc.
• Investigators: Principal Investigator: Paul Nyquist, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 29, 2012
• First Submitted That Met QC Criteria: July 16, 2012
• First Posted (Estimated): July 18, 2012

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Ischemic Stroke
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: NA_00069985