Transforming Research and Clinical Knowledge in Geriatric Traumatic Brain Injury (TRACK-GERI)

NCT07296783 | Enrolling By Invitation

• 5 other identifiers: TRACK-GERI1R01NS110944K23NS0957551K76AG083285W81XWH2110469
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to improve the diagnosis and prediction of recovery after traumatic brain injury (TBI) in adults age 65 years and older. The study will follow older adults who present to the emergency department after TBI, as well as matched control participants, and will measure clinical features, brain imaging, and blood-based biomarkers over 12 months to understand how recovery changes over time. Researchers will examine how pre-injury health, brain structure, and biological markers are related to disability and cognitive outcomes after TBI. Information from this study will be used to develop age-appropriate tools to better diagnose TBI and estimate long-term outcomes in older adults.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Functional Outcome at 6 Months Post-Injury as Assessed by the Glasgow Outcome Scale-Extended (GOSE)

  Functional outcome after traumatic brain injury will be measured using the Glasgow Outcome Scale-Extended (GOSE). The score ranges from 1-8, with higher scores indicating better recovery. The primary outcome is GOSE assessed at 6 months post-injury.

  6 months post-injury

Study Arms (8)

TRACK-GERI TBI Patients

TBI patients

TRACK-GERI Study Partners of TBI Patients

Study partners of TBI patients

TRACK-GERI Controls

Controls

TRQACK-GERI Study Partners of Control Patients

Study partners of control patients

TRACK-VA TBI Patients

VA TBI patients

TRACK-VA Study Partners of TBI Patients

Study partners of VA TBI patients

TRACK-VA Controls

VA controls

TRACK-VA Study Partners of Control Patients

Study partners of VA control patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are those with and without TBI, along with study partners.

You may not qualify if:

• Age 65 years and older, no upper age limit
• Reliable report or physical evidence of head trauma
• Injury occurred \<72 hours ago (within 14 days of injury for TRACK-VA TBI patients)
• Acute brain CT for clinical use
• Fluency in English/Chinese (UCSF only)
• Ability to obtain informed consent from subject or legally authorized representative
• Ability to be co-enrolled with a study partner who meets Study Partner enrollment criteria
• Significant polytrauma that would interfere with follow-up and outcome assessment
• Prisoners or patients in custody
• Patients on psychiatric hold (e.g. 5150, 5250)
• Low likelihood follow-up (participant or family is indicating a low interest, homelessness, out of state/country)
• Current participation in an interventional trial
• Penetrating TBI
• Spinal cord injury with ASIA score of C or worse
• Acute disabling neurological injury (e.g. acute stroke, cardiac arrest concurrent with head trauma presentation)

Sponsors & Collaborators

• University of California, San Francisco: lead
• Doris Duke Charitable Foundation: collaborator
• National Institute on Aging (NIA): collaborator
• United States Department of Defense: collaborator
• US Department of Veterans Affairs: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (3)

University of California, San Francisco

San Francisco, California, 94110, United States

Location

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

• Related Info
• Related Info
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Biospecimen

Retention: SAMPLES WITH DNA

Participants will undergo phlebotomy for whole blood collection.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Geoffrey Manley, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 22, 2025
• Study Start: September 2, 2019
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Shared scientific data will be made accessible as soon as possible, and no later than the time of an associated publication, or the end of performance period, whichever comes first.
• Access Criteria: FITBIR qualified investigators will be provided access.

Locations

US (3)