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

NCT ID: NCT04893837

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 399 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-18
• Study Completion Date: 2025-08-25

Brief Summary

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

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.

Conditions

Brain Injuries, Traumatic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Standard care plus infrascans

Intervention Type: DEVICE

Hourly infrascans to detect expanding intracranial hematomas

Interventions

Standard care plus infrascans

Hourly infrascans to detect expanding intracranial hematomas

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

InfraScan, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Jan O. Jansen

Professor and Director, UAB Center for Injury Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan O Jansen, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham, Center for Injury Science

Locations

UAB Hospital

Birmingham, Alabama, United States

University of Arizona

Tucson, Arizona, United States

Countries

United States

Other Identifiers

20-15-TBI-008

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-300007257

Identifier Type: -

Identifier Source: org_study_id