Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Grant No: RC2NS069409

Coordinating Center: University of California, San Francisco

Purpose:

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:

Study Sites

Principal Investigator

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


Inclusion Criteria:

  1. Presentation to emergency department < 24 hours post-injury
  2. Head CT scan for TBI as part of regular care
  3. 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

 

TRACK-TBI Publications:

Yue JK, Vassar MJ, Lingsma H, Cooper SR, Yuh EL, Mukherjee P, Puccio AM, Gordon W, Okonkwo DO, Valadka A, Schnyer DM, Maas A, Manley GT; TRACK-TBI Investigators. Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Pilot: Multicenter Implementation of the Common Data Elements for Traumatic Brain Injury. J Neurotrauma. 2013 Nov 15;30(22):1831-44.

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 Prior Traumatic Brain Injury on Health and Functioning: a TRACK-TBI Study. J Neurotrauma. 2013 Dec 15;30(24):2014-20.

McMahon PJ, Hricik AJ, Yue JK, Puccio AM, Inoue T, Lingsma H, Beers SR, Gordon W, Valadka, A, 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. 2013 Oct 31. [Epub ahead of print]

Diaz-Arrastia R, Wang KK, Papa L, Sorani MD, Yue JK, Puccio AM, McMahon PJ, Inoue T, Yuh EL, Lingsma H, Maas A, Valadka A, 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. 2013 Oct 9. [Epub ahead of print]

Okonkwo DO, Yue JK, Puccio AM, Panczykowski D, Inoue T, McMahon PJ, Sorani MD, Yuh EL, Lingsma H, Maas A, Valadka A, Manley GT; TRACK-TBI Investigators. GFAP-BDP as an Acute Diagnostic Marker of Traumatic Brain Injury: Results from the Prospective TRACK-TBI Study. J Neurotrauma. 2013 Sep 1;30(17):1490-7.

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. Magnetic Resonance Imaging Improves 3-Month Outcome Prediction in Mild Traumatic Brain Injury. Ann Neurol. 2013 Feb;73(2):224-35.


Additional Information:

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

yuej@neurosurg.ucsf.edu


References: