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

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

Study Overview

• Status: Completed
• Conditions: Brain Injuries, Traumatic
• Intervention / Treatment: Device: Standard care plus infrascans

Detailed Description

MOBI-1 is a single-arm, multi-center derivation / validation study that will evaluate the use of the Infrascanner for monitoring traumatic intracranial hematomas. All patients will receive standard care plus hourly infrascanner assessments. This study will test the hypotheses that:

1. The Infrascanner has sufficient diagnostic performance to detect the expansion of intracranial hematomas
2. Patients who have expanding intracranial hematomas will be identified faster when monitored with hourly infrascanner assessments compared to standard care alone
3. Clinical / research staff will be able to attain all data points and relay the assessments to the medical team.

• Study Type: Observational
• Enrollment (Actual): 399

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB Hospital
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; Hourly infrascans to detect expanding intracranial hematomas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance of the infrascanner	Number of participants whose Infrascan results were accurate	Month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to detection of an enlarging hematoma	Difference in time to detection of hematoma enlargement between Infrascan and second CT across the cohort	0-12 hours

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: United States Department of Defense; InfraScan, Inc.
• Investigators: Principal Investigator: Jan O Jansen, MBBS, PhD, University of Alabama at Birmingham, Center for Injury Science

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Actual): June 17, 2025
• Study Completion (Actual): August 25, 2025

Study Registration Dates

• First Submitted: May 14, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: traumatic brain injury, TBI, intracranial hematoma, ICH
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; DNA Virus Infections; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Hepatitis; Hepatitis, Viral, Animal; Hepatitis, Animal; Animal Diseases; Adenoviridae Infections; Dog Diseases; Brain Injuries, Traumatic; Hepatitis, Infectious Canine
• Other Study ID Numbers: IRB-300007257; 20-15-TBI-008 (Other Grant/Funding Number: MTEC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This data will be uploaded to the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system, as a requirement of the funding agency. Only de-identified data will be shared.
• IPD Sharing Time Frame: Data will be uploaded to FITBIR annually.
• IPD Sharing Access Criteria: Access is through the FITBIR system, per their requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes