Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI)

The overall goal of Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study is to determine the relationships among the clinical, neuroimaging, cognitive, genetic and proteomic biomarker characteristics for the entire spectrum of TBI from concussion to coma. TRACK-TBI will validate biomarkers and outcome measures for clinical trials, advance diagnostic and prognostic models for TBI and improve clinical trial design. The Investigators are enrolling patients within 24 hours of injury who present to a TRACK-TBI site with a brain injury that meets ACRM criteria and receives a clinically indicated head CT.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: In-Person Outcome Assessment; Procedure: 3T Magnetic Resonance Imaging (MRI); Procedure: Blood Draw for Plasma, DNA, Serum, RNA; Behavioral: Phone Outcome Assessment

Detailed Description

Effective treatment of traumatic brain injury (TBI) remains one of the greatest unmet needs in public health. After 3 decades of failed clinical trials, a new approach is needed. Our proposal, Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI), establishes a public-private partnership of experienced TBI investigators, and philanthropic and industry collaborators, who share a mission to accelerate TBI research. TRACK-TBI will create a large, high quality database that integrates clinical, imaging, proteomic, genomic, and outcome biomarkers to establish more precise methods for TBI diagnosis and prognosis, refine outcome assessment, and compare the effectiveness and costs of TBI care.

The Investigators hypothesize that this approach will permit investigators to better characterize and stratify patients, allow meaningful comparisons of treatments and outcomes, and improve the next generation of clinical trials. The Investigators have built on the TRACK-TBI Pilot study (NCT01565551) and our team's precompetitive collaboration, forged by participation in the TBI Common Data Elements project (TBI-CDE) and the International TBI Research Initiative (InTBIR). Having provided the index dataset for the Federal Interagency TBI Research database (FITBIR), the Investigators now propose the following Specific Aims:

Specific Aim 1. To create a widely accessible, comprehensive TBI Information Commons that integrates clinical, imaging, proteomic, genomic, and outcome biomarkers from subjects across the age and injury spectra, and provides analytic tools and resources to support TBI research. Multi- disciplinary teams across 11 sites will enroll 3000 subjects of all ages across the injury spectrum of concussion to coma. Utilizing TBI-CDEs, along with uniform standards for acquiring multi-site MRI data, the Investigators will expand the TRACK-TBI Pilot informatics platform, leveraging existing informatics tools to populate FITBIR, yielding a resource for current and future TBI research and international collaboration.

Specific Aim 2. To validate imaging, proteomic, and genetic biomarkers that will improve classification of TBI, permit appropriate selection and stratification of patients for clinical trials, and contribute to the development of a new taxonomy for TBI. The Investigators hypothesize that validated imaging, proteomic, and genetic biomarkers will permit improved patient classification, beyond traditional categories of mild, moderate and severe TBI.

Subaim 2.1. To establish prognostic imaging biomarkers for TBI based on patho-anatomic analysis of CT and MRI, as well as quantitative MR volumetrics, diffusion tensor imaging (DTI), and resting state functional MRI (R-fMRI).

Subaim 2.2. To identify blood-based biomarkers that will provide additional diagnostic and prognostic information with which to identify TBI phenotypes that can be targeted by specific therapies.

Subaim 2.3. To identify common polymorphisms in candidate genes associated with outcome after TBI, and to elucidate causal molecular mechanisms of injury, response, and repair.

Subaim 2.4. To construct a multidimensional TBI classification system incorporating data from multiple domains that will define homogeneous classes of patients suitable for clinical trial inclusion.

Specific Aim 3. To evaluate a flexible outcome assessment battery comprised of a broad range of TBI common data elements that enables assessment of multiple outcome domains across all phases of recovery and at all levels of TBI severity. When compared with the current gold standard, the Glasgow Outcome Scale Extended (GOSE), the Investigators hypothesize that a flexible and more discriminating outcome battery reflecting multiple functional domains will more precisely and efficiently capture outcomes across the course of recovery, at all levels of TBI severity.

Subaim 3.1. To improve the granularity and breadth of TBI outcomes using a flexible outcome assessment battery that enables basic neurocognitive assessment in subjects too impaired to undergo standard neuropsychological testing, and comprehensive assessment of cognition, functional status, mental health, social participation, and quality of life in those cognitively intact enough to provide valid results.

Subaim 3.2. To determine the efficiency of a flexible outcome assessment battery, as compared with the GOSE, in reducing sample sizes needed to detect differences between groups.

Subaim 3.3. To identify specific TBI phenotypes amenable to targeted interventions, by relating patient classification factors (Subaim 2.4) to different outcome factor scores (Subaim 3.1).

Specific Aim 4. To determine which tests, treatments, and services are effective and appropriate for which TBI patients, and use this evidence to recommend practices that offer the best value. The Investigators will use established comparative effectiveness research (CER) and health economics methods to evaluate the ability of each clinical practice to improve outcomes while containing costs.

Subaim 4.1. To identify patients currently admitted to an ICU who could be safely and effectively cared for in a floor bed or discharged home with outpatient management, and to estimate the health and economic impact of changing the management of these patients.

Subaim 4.2. To determine whether routine follow up improves TBI outcomes and minimizes their economic burden.

Subaim 4.3. To assess variability in management of patients taking antiplatelet agents at the time of TBI, and the effect of management on progression of intracranial hemorrhage, need for craniotomy, and outcome.

The Investigators expect that achievement of these Specific Aims will advance our understanding of TBI, improve clinical trial design, lead to more effective patient-specific treatments, and improve outcome after TBI.

• Study Type: Observational
• Enrollment (Actual): 2996

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • University of California, San Francisco
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health and Hospitals Authority
    • Englewood, Colorado, United States, 80113
      • University of Colorado/Craig Hospital
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Charlestown, Massachusetts, United States, 02129
      • Spaulding Rehabilitation Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • University of Minnesota/Hennepin County Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania/Penn Presbyterian Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Texas
    • Austin, Texas, United States, 78712
      • University of Texas at Austin
    • Austin, Texas, United States, 78701
      • Dell Seton Medical Center
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston
    • Houston, Texas, United States, 77030
      • TIRR Memorial Hermann
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College Of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The Investigators will enroll patients presenting to the Emergency Department with a history of acute TBI within the last 24 hours (acute injury) as per American Congress of Rehabilitation Medicine (ACRM) Criteria, in which the patient has sustained a traumatically induced* physiological disruption of brain function, as manifested by ≥ one of the following:

Any period of loss of consciousness Any loss of memory for events immediately before or after the accident Any alteration of mental state at the time of the accident (feeling dazed, disoriented, and/or confused) Focal neurologic deficits that may or may not be permanent

*Traumatically induced includes the head being struck, the head striking an object, or the brain undergoing an acceleration/deceleration movement without direct external trauma to the head.

Description

Inclusion Criteria:

• Age 18-100 (some sites also enrolling pediatric patients)
• Documented/verified TBI by ACRM Criteria
• Injury occurred within 24 hours of ED arrival
• Acute brain CT as part of clinical care
• Visual acuity and hearing adequate for outcomes testing
• Fluency in English (some sites also enrolling Spanish speakers)

Exclusion Criteria:

• Significant polytrauma that would interfere with follow-up and outcome assessment
• Prisoners or patients in custody
• Pregnancy in female subjects
• Patients on psychiatric hold (e.g. 5150, 5250)
• Major debilitating baseline mental health disorders (e.g. schizophrenia or bipolar disorder) that would interfere with the validity of outcome assessment due to TBI
• Major debilitating neurological disease (e.g. stroke, CVA, dementia, tumor) impairing baseline awareness, cognition, or validity of outcome assessment due to TBI
• Significant history of pre-existing conditions that would interfere with likelihood of follow-up and validity of outcome assessment due to TBI (e.g. major substance abuse, alcoholism, end-stage cancers, learning disabilities, developmental disorders)
• Contraindications for MR (for CA+MRI cohort)
• Low likelihood of follow-up (e.g. participant or family indicating low interest, residence in another state or country, homelessness or lack of reliable contacts)
• Current participant in an interventional trial (e.g. drug, device, behavioral)
• Non-English speakers as most outcome measures are normed in the English language.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Comprehensive Assessment with MRI; In-Person Outcome Assessment at 2 weeks, 6 months, and 12 months.; Phone Outcome Assessment at 3 months.; 3T Magnetic Resonance Imaging (MRI) at 2 weeks and 6 months.; Blood Draw for Plasma, DNA, Serum, RNA at baseline, in hospital (if applicable), 2 weeks, and 6 months (DNA at baseline only).	Behavioral: In-Person Outcome Assessment; NIH Flexible Outcome Assessment Battery Framework Measures In-Person at 2 Weeks, 6 Months, and 12 Months, and by Phone at 3 Months.; Procedure: 3T Magnetic Resonance Imaging (MRI); 3T Research MRI at 2 weeks and 6 months.; Procedure: Blood Draw for Plasma, DNA, Serum, RNA; Blood Draw for Plasma, DNA, Serum, RNA at baseline, in hospital (if applicable), 2 weeks, and 6 months (DNA at baseline only).
Comprehensive Assessment without MRI; In-Person Outcome Assessment at 2 weeks, 6 months, and 12 months.; Phone Outcome Assessment at 3 months.; Blood Draw for Plasma, DNA, Serum, RNA at baseline, in hospital (if applicable), 2 weeks, and 6 months (DNA at baseline only).	Behavioral: In-Person Outcome Assessment; NIH Flexible Outcome Assessment Battery Framework Measures In-Person at 2 Weeks, 6 Months, and 12 Months, and by Phone at 3 Months.; Procedure: 3T Magnetic Resonance Imaging (MRI); 3T Research MRI at 2 weeks and 6 months.; Procedure: Blood Draw for Plasma, DNA, Serum, RNA; Blood Draw for Plasma, DNA, Serum, RNA at baseline, in hospital (if applicable), 2 weeks, and 6 months (DNA at baseline only).
Brief Assessment; • Telephone outcome assessment at 2 weeks, 3 months, 6 months, and 12 months.	Behavioral: Phone Outcome Assessment; NIH Flexible Outcome Assessment Battery Framework Measures by Phone at 2 Weeks, 3 Months, 6 Months, and 12 Months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glasgow Outcome Scale - Extended (GOS-E)	The Glasgow Outcome Scale - Extended (GOS-E) is the current gold standard of outcome for TBI.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3T Brain Structural and Functional Magnetic Resonance Imaging (MRI)	Sagittal 3D T1 MPRAGE/IR-SPGR; Sagittal 3D T2* GRE; Axial Diffusion Tensor Imaging (DTI); Axial Resting State Functional MRI (fMRI); Sagittal 3D T2-FLAIR; Sagittal 3D T2	2 Weeks
Blood Specimen for Analysis of Biomarkers and Genetics	6.0ml blood for plasma and DNA; 6.0ml blood for serum; 2.5ml blood for RNA	Baseline Visit (In-Hospital)
TRACK-TBI Flexible Outcome Assessment Battery Framework (Composite Measure)	Abbreviated Battery; GOS-E; Confusion Assessment Protocol - Cognitive (CAP-COG); Coma Recovery Scale Revised (CRS-R) Comprehensive Assessment Battery; GOS-E; Expanded Disability Rating Scale (E-DRS-PI); Rey Auditory Verbal Learning Test (RAVLT); Trail Making Test (TMT); Wechsler Adult Intelligence Scale IV (WAIS); Brief Test of Adult Cognition by Telephone (BTACT); Rivermead Post-Concussion Symptoms Questionnaire; Pain Intensity and Interference Instruments (PROMIS-PAIN); Insomnia Severity Index (ISI); Quality of Life After Brain Injury Overall Scale (QOLIBRI-OS); Mayo-Portland Adaptability Inventory - Participation (MPAI-PART); Satisfaction with Life Scale (SWLS); 12-Item Short Form Survey (SF-12); Alcohol Use Disorders Identification Test 3-Item (AUDIT-C); 3-Item Drug Use Interview; Post-Traumatic Stress Disorder Checklist 5 (PCL-5); Brief Symptom Inventory 18 (BSI18); Participant Health Questionnaire 9 (PHQ-9)	2 Weeks
TRACK-TBI Flexible Outcome Assessment Battery Framework (Composite Measure)	Abbreviated Battery; GOS-E; Confusion Assessment Protocol - Cognitive (CAP-COG); Coma Recovery Scale Revised (CRS-R) Comprehensive Assessment Battery; GOS-E; Expanded Disability Rating Scale (E-DRS-PI); Rey Auditory Verbal Learning Test (RAVLT); Trail Making Test (TMT); Wechsler Adult Intelligence Scale IV (WAIS); Brief Test of Adult Cognition by Telephone (BTACT); Rivermead Post-Concussion Symptoms Questionnaire; Pain Intensity and Interference Instruments (PROMIS-PAIN); Insomnia Severity Index (ISI); Quality of Life After Brain Injury Overall Scale (QOLIBRI-OS); Mayo-Portland Adaptability Inventory - Participation (MPAI-PART); Satisfaction with Life Scale (SWLS); 12-Item Short Form Survey (SF-12); Alcohol Use Disorders Identification Test 3-Item (AUDIT-C); 3-Item Drug Use Interview; Post-Traumatic Stress Disorder Checklist 5 (PCL-5); Brief Symptom Inventory 18 (BSI18); Participant Health Questionnaire 9 (PHQ-9)	3 Months
TRACK-TBI Flexible Outcome Assessment Battery Framework (Composite Measure)	Abbreviated Battery; GOS-E; Confusion Assessment Protocol - Cognitive (CAP-COG); Coma Recovery Scale Revised (CRS-R) Comprehensive Assessment Battery; GOS-E; Expanded Disability Rating Scale (E-DRS-PI); Rey Auditory Verbal Learning Test (RAVLT); Trail Making Test (TMT); Wechsler Adult Intelligence Scale IV (WAIS); Brief Test of Adult Cognition by Telephone (BTACT); Rivermead Post-Concussion Symptoms Questionnaire; Pain Intensity and Interference Instruments (PROMIS-PAIN); Insomnia Severity Index (ISI); Quality of Life After Brain Injury Overall Scale (QOLIBRI-OS); Mayo-Portland Adaptability Inventory - Participation (MPAI-PART); Satisfaction with Life Scale (SWLS); 12-Item Short Form Survey (SF-12); Alcohol Use Disorders Identification Test 3-Item (AUDIT-C); 3-Item Drug Use Interview; Post-Traumatic Stress Disorder Checklist 5 (PCL-5); Brief Symptom Inventory 18 (BSI18); Participant Health Questionnaire 9 (PHQ-9)	12 Months
3T Brain Structural and Functional Magnetic Resonance Imaging (MRI)	Sagittal 3D T1 MPRAGE/IR-SPGR; Sagittal 3D T2* GRE; Axial Diffusion Tensor Imaging (DTI); Axial Resting State Functional MRI (fMRI); Sagittal 3D T2-FLAIR; Sagittal 3D T2	6 Months
Blood Specimen for Analysis of Biomarkers and Genetics	6.0ml blood for plasma; 6.0ml blood for serum; 2.5ml blood for RNA	2 Weeks
Blood Specimen for Analysis of Biomarkers and Genetics	6.0ml blood for plasma; 6.0ml blood for serum; 2.5ml blood for RNA	6 Months
TRACK-TBI Flexible Outcome Assessment Battery Framework (Composite Measure)	Abbreviated Battery; GOS-E; Confusion Assessment Protocol - Cognitive (CAP-COG); Coma Recovery Scale Revised (CRS-R) Comprehensive Assessment Battery; GOS-E; Expanded Disability Rating Scale (E-DRS-PI); Rey Auditory Verbal Learning Test (RAVLT); Trail Making Test (TMT); Wechsler Adult Intelligence Scale IV (WAIS); Brief Test of Adult Cognition by Telephone (BTACT); Rivermead Post-Concussion Symptoms Questionnaire; Pain Intensity and Interference Instruments (PROMIS-PAIN); Insomnia Severity Index (ISI); Quality of Life After Brain Injury Overall Scale (QOLIBRI-OS); Mayo-Portland Adaptability Inventory - Participation (MPAI-PART); Satisfaction with Life Scale (SWLS); 12-Item Short Form Survey (SF-12); Alcohol Use Disorders Identification Test 3-Item (AUDIT-C); 3-Item Drug Use Interview; Post-Traumatic Stress Disorder Checklist 5 (PCL-5); Brief Symptom Inventory 18 (BSI18); Participant Health Questionnaire 9 (PHQ-9)	6 Months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); National Institutes of Health (NIH); Department of Health and Human Services
• Investigators: Study Director: Ramon Diaz-Arrastia, MD, PhD, University of Pennsylvania; Study Director: Pratik Mukherjee, MD, PhD, University of California, San Francisco; Study Director: Murray B Stein, MD, MPH, University of California, San Diego; Study Director: Geoffrey T. Manley, MD, PhD, University of California, San Francisco; Study Director: Claudia S. Robertson, MD, Baylor College of Medicine; Study Director: David O. Okonkwo, MD, PhD, University of Pittsburgh Medical Center; Study Director: Nancy R. Temkin, PhD, University of Washington; Study Director: Joseph T. Giacino, MD, PhD, Harvard Medical School, Spaulding Rehabilitation Hospital; Principal Investigator: Ann-Christine Duhaime, MD, Harvard Medical School, Massachusetts General Hospital; Principal Investigator: Dana P. Goldman, PhD, University of Southern California; Principal Investigator: Arthur W. Toga, PhD, University of Southern California; Principal Investigator: Kevin Smith, MSIS, University of Michigan; Principal Investigator: Opeolu M. Adeoye, MD, University of Cincinnati; Principal Investigator: Neeraj Badjatia, MD, MS, University of Maryland, College Park; Principal Investigator: Randall M. Chesnut, MD, University of Washington; Principal Investigator: Gillian A. Hotz, PhD, University of Miami; Principal Investigator: Christopher J. Madden, MD, University of Texas; Principal Investigator: Randall E. Merchant, PhD, Virginia Commonwealth University; Principal Investigator: Alex B. Valadka, MD, Seton Healthcare Family; Principal Investigator: Andrew I. Maas, MD, PhD, Antwerp University Hospital, Edegem, Belgium; Principal Investigator: David K. Menon, MD, PhD, University of Cambridge, Cambridge, United Kingdom; Principal Investigator: Isabelle Gagnon, PhD, MS, McGill University; Principal Investigator: Ryan S Kitagawa, MD, The University of Texas Health Science Center, Houston; Principal Investigator: David M Schnyer, PhD, University of Texas, Austin; Principal Investigator: Vincent Y Wang, MD, PhD, MBA, Dell Seton Medical Center; Principal Investigator: David W Wright, MD, FACEP, Emory University; Principal Investigator: Michael McCrea, PhD, ABPP, Medical College Of Wisconsin; Principal Investigator: Gregory Hawryluk, MD, PhD, University of Utah; Principal Investigator: Richard B Rodgers, MD, FAANS, Indiana University; Principal Investigator: Uzma Samadani, MD, PhD, University of Minnesota/Hennepin County Medical Center; Principal Investigator: Mitchell Cohen, MD, Denver Health and Hospital Authority; Principal Investigator: Cindy Harrison-Felix, PhD, FACRM, University of Colorado, Denver/Craig Hospital; Principal Investigator: Roland Torres, MD, University of Miami

Publications and helpful links

General Publications

• Korley FK, Jain S, Sun X, Puccio AM, Yue JK, Gardner RC, Wang KKW, Okonkwo DO, Yuh EL, Mukherjee P, Nelson LD, Taylor SR, Markowitz AJ, Diaz-Arrastia R, Manley GT; TRACK-TBI Study Investigators. Prognostic value of day-of-injury plasma GFAP and UCH-L1 concentrations for predicting functional recovery after traumatic brain injury in patients from the US TRACK-TBI cohort: an observational cohort study. Lancet Neurol. 2022 Sep;21(9):803-813. doi: 10.1016/S1474-4422(22)00256-3.
• Galimberti S, Graziano F, Maas AIR, Isernia G, Lecky F, Jain S, Sun X, Gardner RC, Taylor SR, Markowitz AJ, Manley GT, Valsecchi MG, Bellelli G, Citerio G; CENTER-TBI and TRACK-TBI participants and investigators. Effect of frailty on 6-month outcome after traumatic brain injury: a multicentre cohort study with external validation. Lancet Neurol. 2022 Feb;21(2):153-162. doi: 10.1016/S1474-4422(21)00374-4.
• Campbell-Sills L, Jain S, Sun X, Fisher LB, Agtarap SD, Dikmen S, Nelson LD, Temkin N, McCrea M, Yuh E, Giacino JT, Manley GT, Stein MB; TRACK-TBI Investigators. Risk Factors for Suicidal Ideation Following Mild Traumatic Brain Injury: A TRACK-TBI Study. J Head Trauma Rehabil. 2021 Jan-Feb 01;36(1):E30-E39. doi: 10.1097/HTR.0000000000000602.
• Yue JK, Yuh EL, Korley FK, Winkler EA, Sun X, Puffer RC, Deng H, Choy W, Chandra A, Taylor SR, Ferguson AR, Huie JR, Rabinowitz M, Puccio AM, Mukherjee P, Vassar MJ, Wang KKW, Diaz-Arrastia R, Okonkwo DO, Jain S, Manley GT; TRACK-TBI Investigators. Association between plasma GFAP concentrations and MRI abnormalities in patients with CT-negative traumatic brain injury in the TRACK-TBI cohort: a prospective multicentre study. Lancet Neurol. 2019 Oct;18(10):953-961. doi: 10.1016/S1474-4422(19)30282-0. Epub 2019 Aug 23.

Helpful Links

• NINDS Common Data Elements

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2014
• Primary Completion (Actual): June 22, 2019
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: March 22, 2014
• First Submitted That Met QC Criteria: April 16, 2014
• First Posted (Estimate): April 21, 2014

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Biomarkers; Neuroimaging; Traumatic Brain Injury; Comparative Effectiveness Research; Psychological Health
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 1U01NS086090-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No