Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
300 participants
OBSERVATIONAL
2022-03-01
2027-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transforming Research and Clinical Knowledge in Traumatic Brain Injury
NCT02119182
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
NCT05823766
Biomarkers of Mild and Moderate Traumatic Brain Injury
NCT01295346
Evaluation of Mild TBI in Collegiate Athletes
NCT02189525
Longitudinal Assessment of Traumatic Microvascular Injury-2
NCT05725993
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
TBI is a complex disease process, in which diverse injury subtypes and multiple molecular mechanisms overlap. There is a need to identify and measure these subtypes, in order to develop precision medicine approaches where specific pathobiological processes are targeted by mechanistically appropriate therapies. The absence of validated biomarkers in the neurotrauma field is a barrier to drug development in this area, and there are currently no disease-modifying therapies that limit the burden of TBI. Biomarkers specific for injury mechanisms should be identified to select participants for clinical trials of targeted therapies (prognostic biomarkers), as well as to confirm target engagement and biological efficacy (pharmacodynamic biomarkers).
Traumatic axonal injury (TAI) is a common pathologic consequence of TBI, and underlies some of the most disabling consequences of injury, including cognitive and affective problems. TAI progresses for years after injury in a subset of patients, and is a key mechanism for long-term neurodegeneration after TBI. Recent breakthroughs in pre-clinical models indicate that novel therapeutic interventions, including strategies such as targeting the mitochondrial transition pore, or promoting axonal maintenance factors are effective in promoting resilience of injured axons and improving neurologic outcome after experimental TBI. Translation of such promising therapies into clinical trials will require prognostic biomarkers that can measure TAI in individual patients, so they can be selected for early phase studies of axon-protective therapies, as well pharmacodynamic biomarkers than can measure the biologic efficacy of such treatments. Currently, the best biomarker for TAI is fractional anisotropy (FA) and mean diffusivity (MD) of white matter tracts, measured using diffusion tensor imaging (DTI) MRI. This technique, while robust, is poorly suited for dynamic longitudinal assessments, and measures the end-result of axonal degeneration, rather than an early step in the neurodegenerative process. Recently, the ability to assay axonal proteins in peripheral blood has made it potentially feasible to assess of TAI rapidly, inexpensively, and longitudinally. The axonal protein that holds the most promise as a biomarker of axonal degeneration is neurofilament light chain (NF-L). This project aims to address the gaps in the existing literature regarding specific biomarkers for injury mechanisms and outcomes following TBI. Furthermore, it is likely that a sophisticated understanding of the subtypes and molecular mechanisms of TBI will be required to successfully develop therapies to treat these subtypes.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Telephone Outcome Assessment
Assessments will be administered over the telephone to evaluate participant outcome status
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.
Telephone Outcome Assessment
Assessments will be administered over the telephone to evaluate participant outcome status
In-Person Outcome Assessment
Assessments will be administered to evaluate participant outcome status
3T Magnetic Resonance Imaging (MRI)
Participants will be asked to complete a 3T MRI
Blood Draw
Blood Draw for Plasma, DNA, Serum, RNA
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.
Telephone Outcome Assessment
Assessments will be administered over the telephone to evaluate participant outcome status
In-Person Outcome Assessment
Assessments will be administered to evaluate participant outcome status
3T Magnetic Resonance Imaging (MRI)
Participants will be asked to complete a 3T MRI
Blood Draw
Blood Draw for Plasma, DNA, Serum, RNA
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Telephone Outcome Assessment
Assessments will be administered over the telephone to evaluate participant outcome status
In-Person Outcome Assessment
Assessments will be administered to evaluate participant outcome status
3T Magnetic Resonance Imaging (MRI)
Participants will be asked to complete a 3T MRI
Blood Draw
Blood Draw for Plasma, DNA, Serum, RNA
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Football League
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Pennsylvania
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ramon Diaz-Arrastia, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
834982
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.