Traumatic Brain InjuryTRACK-GERINCT07296783
Transforming Research and Clinical Knowledge in Geriatric Traumatic Brain Injury (TRACK-GERI)
An observational study of Traumatic Brain Injury, run by University of California, San Francisco at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 1,500 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Sep 2019to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Participants are those with and without TBI, along with study partners.
Who may be able to join
- 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
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- Ability to be co-enrolled with a study partner who meets Study Partner enrollment criteria
- Age 18 years or older
- 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).
- Ability to read, write, and speak English/Chinese (UCSF only)
- Ability to provide informed consent for self
- Age 65 years or older, no upper age limit
- Visual acuity/hearing adequate for testing
- 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 (see control study partner enrollment criteria)
- For TRACK-VA patients only: Presentation to SFVAMC ED for acute care with planned discharge from ED.
- Age 18 years or older
- 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.)
- Ability to read, write and speak English/Chinese (UCSF only)
- Ability to provide informed consent for self
Who cannot join
- 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
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- 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)
- TRACK-GERI/VA STUDY PARTNERS OF TBI PATIENTS INCLUSION/EXCLUSION CRITERIA
- 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.
- Prisoners or patients in custody
- Patients on psychiatric hold (e.g. 5150, 5250)
- TRACK-GERI/VA CONTROL SUBJECT INCLUSION/EXCLUSION CRITERIA
- Medically diagnosed with traumatic brain or orthopedic injury in the last year (TRACK-VA Control Subjects are not excluded for orthopedic injuries)
- 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 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)
- TRACK-GERI/VA STUDY PARTNERS OF CONTROL SUBJECTS INCLUSION/EXCLUSION CRITERIA
- 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.
- Prisoners or in custody
- On psychiatric hold (e.g. 5150, 5250)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of California, San Francisco
San Francisco, California, 94110
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121
About this study
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
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start2 Sep 2019
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation, National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA), United States Department of Defense, US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Geoffrey Manley, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296783
- Sponsor's protocol ID
- TRACK-GERI
- Other IDs
- 1R01NS110944, K23NS095755, 1K76AG083285, W81XWH2110469
- Acronym
- TRACK-GERI
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available through the Federal Interagency TBI Research (FITBIR) Database.
Publications
Rosen-Lang Y, Puccio AM, Yuh EL, Lombardi D, Kuang K, Nelson MD, Boscardin WJ, Huie JR, Yaffe K, Okonkwo DO, Arrastia RD, Manley GT, Gardner RC; Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) investigators. 6-Month Recovery after Mild Traumatic Brain Injury in Older Adults: A TRACK-GERI Study. medRxiv [Preprint]. 2026 Jun 29:2026.06.25.26356520. doi: 10.64898/2026.06.25.26356520.
PubMed 42428125
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Research and Clinical Knowledge in Geriatric Traumatic Brain Injury (TRACK-GERI)
- ClinicalTrials.gov ID
- NCT07296783
- Acronym / sponsor ID
- TRACK-GERI / TRACK-GERI
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation, National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA), United States Department of Defense, US Department of Veterans Affairs
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Participants are those with and without TBI, along with study partners.
Key inclusion criteria (21 listed)
- 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)
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Outcome at 6 Months Post-Injury as Assessed by the Glasgow Outcome Scale-Extended (GOSE)
Time frame: 6 months post-injury
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Derived from this study: PubMed 42428125Rosen-Lang Y, Puccio AM, Yuh EL, Lombardi D, Kuang K, Nelson MD, Boscardin WJ, Huie JR, Yaffe K, Okonkwo DO, Arrastia RD, Manley GT, Gardner RC; Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) investigators. 6-Month Recovery after Mild Traumatic Brain Injury in Older Adults: A TRACK-GERI Study. medRxiv [Preprint]. 2026 Jun 29:2026.06.25.26356520. doi: 10.64898/2026.06.25.26356520.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be made available through the Federal Interagency TBI Research (FITBIR) Database.
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
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Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
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Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
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Nanopulse Laser Therapy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Geoffrey Manley, MD, PhD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by University of California, San Francisco at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Outcome at 6 Months Post-Injury as Assessed by the Glasgow Outcome Scale-Extended (GOSE) (time frame: 6 months post-injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07296783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.