TRACK-TBI Longitudinal Biomarker Study
TRACK-BIO
Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI)- a Longitudinal Biomarker Study
2 other identifiers
observational
300
1 country
11
Brief Summary
The overarching goal of this study is to improve understanding of the long-range natural history of TBI by extending follow-up of a previously enrolled cohort (TRACK-TBI) beyond the first 12 months after injury.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2022
CompletedFirst Posted
Study publicly available on registry
January 21, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
ExpectedJuly 16, 2025
July 1, 2025
4 years
January 7, 2022
July 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Glasgow Outcome Scale Extended (GOSE)
The GOSE provides an overall measure of functional status based on information on cognition, independence, employability, and social/community participation collected via structured interview. Individuals are described by one of the eight outcome categories: Dead (1); Vegetative State (2); Lower Severe Disability (3); Upper Severe Disability (4); Lower Moderate Disability (5); Upper Moderate Disability (6); Lower Good Recovery (7) and Upper Good Recovery (8). Good Recovery is defined as a score of 7-8, Moderate Disability is defined by a score of 5-6 and Severe Disability is defined by a score of 3-4.
~4-6 years post-injury
Secondary Outcomes (1)
Serum NF-L (neurofilament light chain)
~4-6 years post-injury
Study Arms (3)
Telephone Assessment Battery
TRACK-TBI participants may complete up to three annual telephone calls to assess outcome status. These assessments will determine eligibility for the in-person study visit.
Comprehensive Assessment Battery (CAB)
Participants who demonstrate decision-making capacity will be asked to complete the Comprehensive Assessment Battery (CAB). The CAB in-person is comprised of measures of cognition (i.e. attention, memory, information processing speed, executive functions), mood (i.e., depression, anxiety), social participation, subjective well-being, post-traumatic stress, interviews, global functional status measures, and a COVID-19 questionnaire.
Abbreviated Assessment Battery (AAB)
Participants who do not have decision-making capacity will be asked to complete a modified assessment battery, called the Abbreviated Assessment Battery (AAB). The AAB in-person assessment will administer the Speech Intelligibility, GOAT, and CAP and/or CRS-R to study participants.
Interventions
Assessments will be administered over the telephone to evaluate participant outcome status
Assessments will be administered to evaluate participant outcome status
Participants will be asked to complete a 3T MRI
Blood Draw for Plasma, DNA, Serum, RNA
Eligibility Criteria
Participants enrolled in TRACK-TBI
You may qualify if:
- LONGITUDINAL Telephone Assessment:
- Participated in TRACK-TBI,
- At least two years post injury, and
- Completed at least 1 GOSE during the TRACK-TBI follow-up assessments
- LONGITUDINAL BIOMARKER In-Person Assessment:
- Must complete at least one Longitudinal Telephone Assessment and fall into one of the following groups:
- Group 1- Completed TRACK-TBI 6M MRI and are stable or improved with regard to Criteria for Establishing Decline
- Group 2- Criteria for Establishing Decline met when comparing the Telephone Assessments to the last completed TRACK-TBI assessment
- Group 3- All TRACK-TBI orthopedic controls
- Ability of participant or legally authorized representative to provide informed consent
You may not qualify if:
- Dementia diagnosed prior to the index TBI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University of California, San Francisco
San Francisco, California, 94110, United States
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
University of Pennsylvania/Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
University of Texas at Austin
Austin, Texas, 78712, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
University of Washington
Seattle, Washington, 98104, United States
Biospecimen
Biofluids that will be collected and stored include serum, plasma, DNA and RNA. Samples will be banked at -80 degrees Celsius.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ramon Diaz-Arrastia, MD, PhD
University of Pennsylvania
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2022
First Posted
January 21, 2022
Study Start
March 1, 2022
Primary Completion
February 28, 2026
Study Completion (Estimated)
February 28, 2027
Last Updated
July 16, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share