Clinical trial NCT03148340: Volumetric Integral Phase-shift Spectroscopy for Noninvasive Detection of Hemispheric Bioimpedance Asymmetry in Acute Brain Pathology
Official title: VITAL: Volumetric Integral Phase-shift Spectroscopy (VIPS) for the Noninvasive Detection of Hemispheric Bioimpedance Asymmetry in Acute Brain Pathology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Stroke, Acute
Ischemic Stroke
Hemorrhage
Clot (Blood); Brain
Subarachnoid Hemorrhage
Cerebral Infarction
Cerebral Hemorrhage
Cerebral Stroke
Intracerebral Hemorrhage
Intracerebral Injury
Lead sponsor: Cerebrotech Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-11
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females, aged 18 years or older, who are undergoing evaluation for acute ischemic stroke

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hemispheric bioimpedance asymmetry detection
timeFrame: At the time of VIPS monitoring - day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Lyerly Baptist, Inc
state: Florida
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
References:
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