Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Grant No: RC2NS069409
Coordinating Center: University of California, San Francisco
The global aim of this proposal is to test and refine Common Data Elements (CDEs), neuroimaging standards, and best practices for genetics and proteomics in Traumatic Brain Injury (TBI) studies. The investigators anticipate that this project has the potential to substantially advance and revolutionize clinical research in TBI. Repositories for neuroimaging, proteomic, and genetic biomarkers will facilitate the evolving field of these emerging technologies in TBI.
Testing and validating of TBI-CDEs will be performed in a multi-center prospective observational study with 3 Acute TBI Centers and 1 Rehabilitation Center:
UCSF, San Francisco General Hospital
Geoffrey Manley, MD, PhD
University of Pittsburgh Medical Center
David Okonkwo, MD, PhD
University Medical Center Brackenridge
Alex Valadka, MD
Mount Sinai Rehabilitation Center
Wayne Gordon, PhD
- Presentation to emergency department < 24 hours post-injury
- Head CT scan for TBI as part of regular care
- English speaking (outcome measures have not been normed for non-English)
Study Components (Ref: NIH-NINDS TBI Common Data Elements):
1. Clinical care, demographic and outcome data collection.
2. Blood draws for proteomic and genetic marker analyses.
3. 3T Magnetic Resonance Imaging will be completed on a subset of patients able to return 1-2 weeks post-injury.
4. Three month follow up. The Glasgow Outcome Scale - Extended (GOS-E) and neurological symptoms inventory will be administered to patients over the phone 3 months post-injury.
5. Six, twelve and twenty-four month neurocognitive assessments. Standardized measures from all designated CORE domains for outcome after TBI by the CDEs which include:
- Global recovery
- Functional outcome
- Psychological impairment
- Post-traumatic stress disorder (PTSD)
- Quality of life
Yue JK, Pronger AM, Ferguson AR, Temkin NR, Sharma S, Rosand J, Sorani MD, McAllister TW, Barber J, Winkler EA, Burchard EG, Hu D, Lingsma HF, Cooper SR, Puccio AM, Okonkwo DO, Diaz-Arrastia R, Manley GT; COBRIT Investigators; TRACK-TBI Investigators. Association of a Common Genetic Variant Within ANKK1 With Six-Month Cognitive Performance After Traumatic Brain Injury. Neurogenetics. 2015 Jul; 16(3): 169-80. PMID 25633559.
McMahon PJ, Panczykowski DM, Yue JK, Puccio AM, Inoue T, Sorani MD, Lingsma HF, Maas AI, Valadka AB, Yuh EL, Mukherjee P, Manley GT, Okonkwo DO; TRACK-TBI Investigators. Measurement of the Glial Fibrillary Acidic Protein and Its Breakdown Products GFAP-BDP Biomarker for the Detection of Traumatic Brain Injury Compared to Computed Tomography and Magnetic Resonance Imaging. J Neurotrauma. 2015 Apr 15; 32(8): 527-33. PMID 25264814.
Sorani MD, Yue JK, Sharma S, Manley GT, Ferguson AR; TRACK-TBI Investigators. Genetic Data Sharing and Privacy. Neuroinformatics. 2015 Jan; 13(1): 1-6. PMID 25326433.
Lingsma HF, Yue JK, Maas AI, Steyerberg EW, Manley GT, TRACK-TBI Investigators. Outcome Prediction after Mild and Complicated Mild Traumatic Brain Injury: External Validation of Existing Models and Identification of New Predictors using the TRACK-TBI Pilot Study. J Neurotrauma. 2015 Jan 15; 32(2): 83-94. PMID 25025611.
Yuh EL, Cooper SR, Mukherjee P, Yue JK, Lingsma HF, Gordon WA, Valadka AB, Okonkwo DO, Schnyer DM, Vassar MJ, Maas AI, Manley GT; TRACK-TBI Investigators. Diffusion Tensor Imaging for Outcome Prediction in Complicated and Uncomplicated Mild Traumatic Brain Injury: A TRACK-TBI Study. J Neurotrauma. 2014 Sep 1; 31(17): 1457-77. PMID 24742275.
Ratcliff JJ, Adeoye O, Lindsell CJ, Hart KW, Pancioli A, McMullan JT, Yue JK, Nishijima DK, Gordon WA, Valadka AB, Okonkwo DO, Lingsma HF, Maas AI, Manley GT; TRACK-TBI Investigators. Emergency Department Disposition of the GCS 13-15 Traumatic Brain Injury Patient: Analysis of the TRACK-TBI Study. Am J Emergency Med. 2014 Aug; 32(8): 844-50. PMID 24857248.
McMahon P, Hricik A, Yue JK, Puccio AM, Inoue T, Lingsma HF, Beers SR, Gordon WA, Valadka AB, Manley GT, Okonkwo DO; TRACK-TBI Investigators. Symptomatology and Functional Outcome in Mild Traumatic Brain Injury: Results from the Prospective TRACK-TBI Study. J Neurotrauma. 2014 Jan 1; 31(1): 26-33. PMID 23952719.
Diaz-Arrastia R, Wang KK, Papa L, Sorani MD, Yue JK, Puccio AM, McMahon PJ, Inoue T, Yuh EL, Lingsma HF, Maas AI, Valadka AB, Okonkwo DO, Manley GT; TRACK-TBI Investigators. Acute Biomarkers of Traumatic Brain Injury: Relationship between Plasma Levels of Ubiquitin C-Terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP). J Neurotrauma. 2014 Jan 1; 31(1): 19-25. PMID 23865516.
Dams-O’Connor K, Spielman L, Singh A, Gordon WA, Lingsma HF, Maas AI, Manley GT, Mukherjee P, Okonkwo DO, Puccio AM, Schnyer DM, Valadka AB, Yue JK, Yuh EL; TRACK-TBI Investigators. The Impact of Previous Traumatic Brain Injury on Health and Functioning: A TRACK-TBI Study. J Neurotrauma. 2013 Dec 15; 30(24): 2014-20. PMID 23924069.
Yue JK, Vassar MJ, Lingsma HF, Cooper SR, Okonkwo DO, Valadka AB, Gordon WA, Maas AI, Mukherjee P, Yuh EL, Puccio AM, Schnyer DM, Manley GT; TRACK-TBI Investigators. Transforming Research and Clinical Knowledge in Traumatic Brain Injury Pilot: Multicenter Implementation of the Common Data Elements for Traumatic Brain Injury. J Neurotrauma. 2013 Nov 15; 30(22): 1831-44. PMID 23815563.
Okonkwo DO, Yue JK, Puccio AM, Panczykowski DM, Inoue T, McMahon PJ, Sorani MD, Yuh EL, Lingsma HF, Maas AI, Valadka AB, Manley GT; TRACK-TBI Investigators. GFAP-BDP as an Acute Diagnostic Marker in Traumatic Brain Injury: Results from the Prospective Transforming Research and Clinical Knowledge in Traumatic Brain Injury Study. J Neurotrauma. 2013 Sep 1; 30(17): 1490-7. PMID 23489259.
Yuh EL, Mukherjee P, Lingsma HF, Yue JK, Ferguson AR, Gordon WA, Valadka AB, Schnyer DM, Okonkwo DO, Maas AI, Manley GT; TRACK-TBI Investigators. MRI Improves 3-Month Outcome Prediction in Mild Traumatic Brain Injury. Ann Neurol. 2013 Feb; 73(2): 224-35. PMID 23224915.
Detailed Study Protocol at ClinicalTrials.gov: NCT01565551
NIH-NINDS Common Data Elements for Traumatic Brain Injury
For more information contact:
John Yue, CCRC
Clinical Trial Manager
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