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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by University of California, San Francisco
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Department of Health and Human Services
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02119182
First received: March 22, 2014
Last updated: May 12, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Traumatic Brain Injury Behavioral: In-Person Outcome Assessment Behavioral: Phone Outcome Assessment Procedure: 3T Magnetic Resonance Imaging (MRI) Procedure: Blood Draw for Plasma, DNA, Serum, RNA

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transforming Research and Clinical Knowledge in Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Glasgow Outcome Scale - Extended (GOS-E) [ Time Frame: 6 Months ]
    The Glasgow Outcome Scale - Extended (GOS-E) is the current gold standard of outcome for TBI.


Secondary Outcome Measures:
  • 3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) [ Time Frame: 2 Weeks ]
    • 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

  • Blood Specimen for Analysis of Biomarkers and Genetics [ Time Frame: Baseline Visit (In-Hospital) ]
    • 7.0ml blood for plasma and DNA
    • 7.0ml blood for serum
    • 2.5ml blood for RNA

  • TRACK-TBI Flexible Outcome Assessment Battery Framework (Composite Measure) [ Time Frame: 2 Weeks ]

    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)

  • TRACK-TBI Flexible Outcome Assessment Battery Framework (Composite Measure) [ Time Frame: 3 Months ]

    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)

  • TRACK-TBI Flexible Outcome Assessment Battery Framework (Composite Measure) [ Time Frame: 12 Months ]

    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)

  • 3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) [ Time Frame: 6 Months ]
    • 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

  • Blood Specimen for Analysis of Biomarkers and Genetics [ Time Frame: 2 Weeks ]
    • 7.0ml blood for plasma and DNA
    • 7.0ml blood for serum
    • 2.5ml blood for RNA

  • Blood Specimen for Analysis of Biomarkers and Genetics [ Time Frame: 6 Months ]
    • 7.0ml blood for plasma and DNA
    • 7.0ml blood for serum
    • 2.5ml blood for RNA

  • TRACK-TBI Flexible Outcome Assessment Battery Framework (Composite Measure) [ Time Frame: 6 Months ]

    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)


Biospecimen Retention:   Samples With DNA
Plasma, Serum, DNA, and RNA will be collected at the time of injury. Plasma, Serum, and RNA will be collected at Day 3 and Day 5 if patient is in the hospital, and at 2 weeks and 6 months post-injury. Samples will be banked at -80 degrees Celsius.

Estimated Enrollment: 3000
Study Start Date: February 2014
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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, 2 weeks, and 6 months.
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 at baseline, 2 weeks, and 6 months.
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, 2 weeks, and 6 months.
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 at baseline, 2 weeks, and 6 months.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

We will enroll adult patients of all ages presenting to the Emergency Department with a history of acute TBI 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.

Criteria

Inclusion Criteria:

  • Age 18-100
  • 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
  • Ability to provide informed consent

Exclusion Criteria:

  • Significant polytrauma that woudl 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 partipant 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02119182

Contacts
Contact: John Yue, BA, CCRC 415-206-4457 yuej@neurosurg.ucsf.edu
Contact: Mary Vassar, RN, MS 415-206-8300 vassarm@neurosurg.ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94110
Contact: John K. Yue, BA, CCRC    415-206-4457    yuej@neurosurg.ucsf.edu   
Principal Investigator: Geoffrey T. Manley, MD, PhD         
Principal Investigator: Pratik Mukherjee, MD, PhD         
Principal Investigator: Esther L. Yuh, MD, PhD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Karla A. Gonzalez, MA, CCRC    305-585-6096    k.gonzalez51@med.miami.edu   
Principal Investigator: Gillian A. Hotz, PhD         
Principal Investigator: M. Ross Bullock, MD, PhD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Christin Kinman, MPH    410-328-6844      
Principal Investigator: Neeraj Badjatia, MD         
United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Boston, Massachusetts, United States, 02129
Contact: Sabrina R. Taylor, PhD    617-952-6392    srtaylor@partners.org   
Contact: Yelena Guller, PhD    617-952-6308    yguller@partners.org   
Principal Investigator: Joseph T. Giacino, PhD         
Principal Investigator: Ross Zafonte, DO         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02214
Contact: Frederique Wittkampf, BA    617-726-6354    fwittkampf@partners.org   
Principal Investigator: Ann-Christine Duhaime, MD         
Principal Investigator: Jonathan Rosand, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Susan K. Roll, RN, BSN    513-558-6061    rollsn@ucmail.uc.edu   
Principal Investigator: Opeolu Adeoye, MD         
Principal Investigator: Arthur M. Pancioli, MD         
Principal Investigator: Jason T. McMullan, MD         
Principal Investigator: Christopher J. Lindsell, PhD         
Principal Investigator: Jonathan J. Ratcliff, MD         
Principal Investigator: Norberto Andaluz, MD         
Principal Investigator: Jed A. Hartings, PhD         
Principal Investigator: Achala S. Vagal, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kerri Hochberger, RN    412-648-0051    hochbergerks@upmc.edu   
Principal Investigator: David O. Okonkwo, MD, PhD         
Principal Investigator: Ava M. Puccio, RN, PhD         
United States, Texas
University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Krishna M. Saini, BA    512-324-8300 ext 77730    kmsaini@seton.org   
Principal Investigator: Alex B. Valadka, MD         
Principal Investigator: David M. Schnyer, PhD         
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Susie Madison, RN    214-648-2965    susie.madison@utsouthwestern.edu   
Principal Investigator: Christopher J. Madden, MD         
Principal Investigator: Hunt H. Batjer, MD         
Principal Investigator: Kim L. Rickert, MD         
Principal Investigator: Stephen A. Figueroa, MD         
Principal Investigator: Christiana E. Hall, MD         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Santhosh Sadasivan, MD    713-873-2789    sadasiva@bcm.edu   
Principal Investigator: Claudia S. Robertson, MD         
Principal Investigator: Harvey S. Levin, PhD         
Principal Investigator: Paulina Sergot, MD         
TIRR Memorial Hermann Recruiting
Houston, Texas, United States, 77030
Contact: Luis Gonzalez, BA    713-797-7106    luis.gonzalez@memorialhermann.org   
Principal Investigator: Mark Sherer, PhD         
Principal Investigator: Angelle M. Sander, PhD         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Randall E. Merchant, PhD    804-338-0481    rmerchan@vcu.edu   
Principal Investigator: Randall E. Merchant, PhD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98104
Contact: Sara Wellnitz, RN    206-744-9319    wellnitz@uw.edu   
Principal Investigator: Nancy R. Temkin, PhD         
Principal Investigator: Sureyya S. Dikmen, PhD         
Principal Investigator: Randall M. Chesnut, MD         
Sponsors and Collaborators
University of California, San Francisco
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Department of Health and Human Services
Investigators
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
Study Director: Ramon Diaz-Arrastia, MD, PhD Uniformed Services University of the Health Sciences
Study Director: Nancy R. Temkin, PhD University of Washington
Study Director: Pratik Mukherjee, MD, PhD University of California, San Francisco
Study Director: Joseph T. Giacino, MD, PhD 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
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
  More Information

Additional Information:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02119182     History of Changes
Other Study ID Numbers: 1U01NS086090-01 ( US NIH Grant/Contract Award Number )
Study First Received: March 22, 2014
Last Updated: May 12, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:
Traumatic Brain Injury
Biomarkers
Neuroimaging
Psychological Health
Comparative Effectiveness Research

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on June 22, 2017