Non-Invasive Monitoring of Traumatic Brain Injury Progression Using the Infrascanner (MOBI-1)

NCT04893837 | Completed DMC FDA Device

• 2 other identifiers: IRB-30000725720-15-TBI-008
• Study Type: observational
• Target: 399
• Locations: 1 country
• Sites: 2

Brief Summary

MOBI-1 is a multicenter clinical trial that will evaluate the use of the Infrascanner for the monitoring of traumatic intracranial hematomas.

Conditions

Brain Injuries, Traumatic

Keywords

traumatic brain injury, TBI, intracranial hematoma, ICH

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of the infrascanner

  Number of participants whose Infrascan results were accurate

  Month 24

Secondary Outcomes (1)

• Time to detection of an enlarging hematoma

  0-12 hours

Study Arms (1)

Standard care plus infrascans

All participants will receive regular clinical neurological assessments as ordered by the clinical care team. In addition, a research team member will perform an infrascan. This process will be repeated hourly at the same timepoint as the clinical neurological assessments. If a patient's neurological status deteriorates at any time point, and the medical team orders an early (unplanned) CT scan, the neurological data collection will cease once the patient is sent to CT. Infrascan results will not be shared with the clinical care team, and will not guide the participants' care in any way.

Device: Standard care plus infrascans

Interventions

Standard care plus infrascans DEVICE

Hourly infrascans to detect expanding intracranial hematomas

Standard care plus infrascans

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will enroll up to 440 patients over 14 months, at 10 trauma centers. Currently, there are no high quality published datasets or literature to document the mean or variability in time to the detection of hematoma expansion that could be used for meaningful sample size projections. Therefore, this study has been designed to provide reasonable estimates of the future study outcomes.

You may qualify if:

• Age 15 or older
• Admission CT Scan shows intracranial hemorrhage
• Glasgow Coma Scale less than 15
• Neurosurgery service determines initial care is nonoperative
• Admitted for observation for TBI, to either step-down unit or intensive care unit

You may not qualify if:

• Inability to provide informed consent or lack of a legally authorized representative (LAR)
• Admitted and observed for \>2 hours prior to screening (i.e., has already received second neurological check)
• Other injuries deemed non-survivable
• Diagnosed with hemorrhagic shock or receives a large volume transfusion (\>3 units of any blood product within any 1 hour)
• Planned surgical interventions/ procedures during study period (before the second CT scan)
• Known prisoner

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• United States Department of Defense: collaborator
• InfraScan, Inc.: collaborator

Study Sites (2)

UAB Hospital

Birmingham, Alabama, 35233, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Hepatitis, Infectious Canine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Hepatitis, Viral, Animal; Hepatitis, Animal; Infections; Adenoviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis; Liver Diseases; Digestive System Diseases; Dog Diseases; Animal Diseases

Study Officials

• Jan O Jansen, MBBS, PhD

  University of Alabama at Birmingham, Center for Injury Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, UAB Center for Injury Science

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 20, 2021
• Study Start: April 18, 2022
• Primary Completion: June 17, 2025
• Study Completion: August 25, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be uploaded to FITBIR annually.
• Access Criteria: Access is through the FITBIR system, per their requirements.

Locations

US (2)