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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Traumatic Brain Injury

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • University of California, San Francisco
    • San Francisco, California, United States, 94121
      • San Francisco Veterans Affairs Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

TRACK-GERI/VA TBI PATIENT INCLUSION/EXCLUSION CRITERIA

Inclusion Criteria:

1. Age 65 years and older, no upper age limit
2. Reliable report or physical evidence of head trauma
3. Injury occurred <72 hours ago (within 14 days of injury for TRACK-VA TBI patients)
4. Acute brain CT for clinical use
5. Fluency in English/Chinese (UCSF only)
6. Ability to obtain informed consent from subject or legally authorized representative
7. Ability to be co-enrolled with a study partner who meets Study Partner enrollment criteria

Exclusion Criteria:

1. Significant polytrauma that would interfere with follow-up and outcome assessment
2. Prisoners or patients in custody
3. Patients on psychiatric hold (e.g. 5150, 5250)
4. Low likelihood follow-up (participant or family is indicating a low interest, homelessness, out of state/country)
5. Current participation in an interventional trial
6. Penetrating TBI
7. Spinal cord injury with ASIA score of C or worse
8. Acute disabling neurological injury (e.g. acute stroke, cardiac arrest concurrent with head trauma presentation)

TRACK-GERI/VA STUDY PARTNERS OF TBI PATIENTS INCLUSION/EXCLUSION CRITERIA

Inclusion Criteria:

1. Age 18 years or older
2. Either designated by the patient, presents with patient to the Emergency Department, is listed in the patient's medical chart as an alternate/emergency contact, or is the patient's case manager/social worker, and knows the patient well enough to comment on the patient's health and functional status (e.g. may be family member, friend, caregiver, case manager, etc).
3. Ability to read, write, and speak English/Chinese (UCSF only)
4. Ability to provide informed consent for self

Exclusion Criteria:

1. Pre-existing and major disabling medical, psychiatric, or other neurological disease (e.g. dementia) that interferes with ability to provide evaluation of patient's health and functional status.
2. Prisoners or patients in custody
3. Patients on psychiatric hold (e.g. 5150, 5250)

TRACK-GERI/VA CONTROL SUBJECT INCLUSION/EXCLUSION CRITERIA

Inclusion Criteria:

1. Age 65 years or older, no upper age limit
2. Visual acuity/hearing adequate for testing
3. Fluency in English/Chinese (UCSF only)
4. Ability to obtain informed consent from subject or legally authorized representative
5. Ability to be co-enrolled with a study partner who meets study partner enrollment criteria (see control study partner enrollment criteria)
6. For TRACK-VA patients only: Presentation to SFVAMC ED for acute care with planned discharge from ED.

Exclusion Criteria:

1. Medically diagnosed with traumatic brain or orthopedic injury in the last year (TRACK-VA Control Subjects are not excluded for orthopedic injuries)
2. Significant polytrauma that would interfere with follow-up and outcome assessment
3. Prisoners or patients in custody
4. Patients on psychiatric hold (e.g. 5150, 5250)
5. Low likelihood follow-up (participant or family is indicating low interest, homelessness, out of state/country)
6. Current participation in an interventional trial
7. Penetrating TBI
8. Spinal cord injury with ASIA score of C or worse
9. Acute disabling neurological injury (e.g. acute stroke, cardiac arrest)

TRACK-GERI/VA STUDY PARTNERS OF CONTROL SUBJECTS INCLUSION/EXCLUSION CRITERIA

Inclusion Criteria:

1. Age 18 years or older
2. Designated by the control subject as someone who knows the subject well enough to comment on their health and functional starus (e.g., may be family member, friend, caregiver, case manager, etc.)
3. Ability to read, write and speak English/Chinese (UCSF only)
4. Ability to provide informed consent for self

Exclusion Criteria:

1. Pre-existing and major disabling medical, psychiatric, or other neurological disease (e.g. dementia) that interferes with ability to provide evaluation of control subject's health and functional status.
2. Prisoners or in custody
3. On psychiatric hold (e.g. 5150, 5250)

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); United States Department of Defense; National Institute on Aging (NIA); US Department of Veterans Affairs; Doris Duke Charitable Foundation
• Investigators: Principal Investigator: Geoffrey Manley, MD, PhD, University of California, San Francisco

Publications and helpful links

Helpful Links

• Related Info
• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: TRACK-GERI; 1R01NS110944 (U.S. NIH Grant/Contract); K23NS095755 (U.S. NIH Grant/Contract); 1K76AG083285 (U.S. NIH Grant/Contract); W81XWH2110469 (Other Grant/Funding Number: United States Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available through the Federal Interagency TBI Research (FITBIR) Database.
• IPD Sharing 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.
• IPD Sharing Access Criteria: FITBIR qualified investigators will be provided access.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No