Status:
ACTIVE_NOT_RECRUITING
TRACK-TBI Longitudinal Biomarker Study
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Football League
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
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 af...
Detailed Description
This longitudinal observational study is part of the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) initiative, a multi-institutional project designed to characteri...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Dementia diagnosed prior to the index TBI
Key Trial Info
Start Date :
March 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05201833
Start Date
March 1 2022
End Date
February 28 2027
Last Update
July 16 2025
Active Locations (11)
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1
University of California, San Francisco
San Francisco, California, United States, 94110
2
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States, 02129
3
University of Cincinnati
Cincinnati, Ohio, United States, 45267
4
University of Pennsylvania/Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104