TRACK-TBI Longitudinal Biomarker Study

Running, not enrolling

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT05201833

Run by

University of Pennsylvania

People needed

300

Starts

2022-03-01

Expected to finish

2027-02-28

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Spaulding Rehabilitation Hospital — Charlestown, Massachusetts, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• University of Pennsylvania/Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Texas at Austin — Austin, Texas, United States
• University of Texas Southwestern — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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