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

Completed

Conditions studied: Stroke, Stroke, Acute, Ischemic Stroke, Hemorrhage, Clot (Blood); Brain, Subarachnoid Hemorrhage, Cerebral Infarction, Cerebral Hemorrhage, Cerebral Stroke, Intracerebral Hemorrhage, Intracerebral Injury

In brief

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).

Key facts

Study ID

NCT03148340

Run by

Cerebrotech Medical Systems, Inc.

People needed

287

Starts

2017-04-14

Expected to finish

2018-07-15

Last updated by the study team

2018-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be at least 18 years of age.
• Being evaluated for acute ischemic stroke.
• Able to safely wear the study device for up to 2 minutes per reading.
• Have NIHSS performed before before study device monitoring.
• 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).

You may not qualify if…

• Known or suspected traumatic brain injury, either closed or penetrating.
• Contraindication to neuroimaging, such as a contrast allergy, or other condition that prohibits CT, MRI, and/or angiography.
• Presence of any implanted electro-stimulating devices in the head and neck.
• 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.)
• Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device.
• Under arrest or otherwise in custody.
• Inability to wear the investigational device (skin lesions on scalp, previous intracranial surgeries, etc.).
• Pregnant or nursing.
• 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.

Where it is running

• Lyerly Baptist, Inc — Jacksonville, Florida, United States
• University of Buffalo — Buffalo, New York, United States
• The Mount Sinai Hospital — New York, New York, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Tennessee Health Science Center — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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