Volumetric Integral Phase-shift Spectroscopy for Noninvasive Detection of Hemispheric Bioimpedance Asymmetry in Acute Brain Pathology

Completed

• Conditions: Stroke; Hemorrhage; Stroke, Acute; Clot (Blood); Brain; Cerebral Stroke; Intracerebral Injury; Cerebral Hemorrhage; Ischemic Stroke; Subarachnoid Hemorrhage; Cerebral Infarction
• Interventions: Diagnostic Test: VIPS Monitoring

• Registration Number: NCT03148340
• Lead Sponsor: Cerebrotech Medical Systems, Inc.

Brief Summary

The purpose of this study is to assess the ability of the Fluids Monitor to detect hemispheric bioimpedance asymmetry associated with acute brain pathology in patients presenting with suspected Acute Ischemic Stroke (AIS).

Detailed Description

A prospective non-significant-risk (NSR) multi-site observational study. This study will examine up to 318 subjects undergoing evaluation for acute brain pathology who directly arrive at, or are transferred to, the participating sites.

Study Timeline

• Study Start: 2017-04-14
• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-11
• Primary Completion: 2018-05-10
• Study Completion: 2018-07-15
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-10
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

Inclusion Criteria

1. Must be at least 18 years of age.
2. Being evaluated for acute ischemic stroke.
3. Able to safely wear the study device for up to 2 minutes per reading.
4. Have NIHSS performed before before study device monitoring.
5. Must be able to provide written Informed Consent (either self or via an LAR) at any point during the hospital stay, or if unable to provide such consent, must have permission granted by the governing IRB to enroll in the study (i.e., waiver of consent).

Exclusion Criteria

1. Known or suspected traumatic brain injury, either closed or penetrating.
2. Contraindication to neuroimaging, such as a contrast allergy, or other condition that prohibits CT, MRI, and/or angiography.
3. Presence of any implanted electro-stimulating devices in the head and neck.
4. Presence of any large metallic craniofacial implants, such as bone fixation plates, mesh, et cetera. (Note that small metallic objects, such an aneurysm coils, are acceptable.)
5. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device.
6. Under arrest or otherwise in custody.
7. Inability to wear the investigational device (skin lesions on scalp, previous intracranial surgeries, etc.).
8. Pregnant or nursing.
9. Any other condition, which in the judgment of the PI would prevent the patient from completing the study or tolerating monitoring sessions and brain imaging, such as mental illness, severe agitation, or hemodynamic instability.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VIPS monitoring group	VIPS Monitoring	The study population will consist of adult patients presenting for evaluation of acute brain pathology,

Primary Outcome Measures

Name	Time	Method
Hemispheric bioimpedance asymmetry detection	At the time of VIPS monitoring - day 0	The primary outcome will be the device's ability to detect hemispheric bioimpedance asymmetry associated with acute brain pathology in a population of patients presenting with symptoms consistent with AIS

Trial Locations

Locations (5)

Lyerly Baptist, Inc; 🇺🇸 Jacksonville, Florida, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States

University of Buffalo; 🇺🇸 Buffalo, New York, United States

The Mount Sinai Hospital; 🇺🇸 New York, New York, United States