Traumatic Brain Injury Research Advances with $18.8 million NIH Award

Worldwide research on concussion and traumatic brain injury (TBI) is expected to advance as a result of an award of $18.8 million over five years from the National Institutes of Health (NIH) to support research projects at more than 20 institutions throughout the country.

 The NIH award, part of one of the largest international research collaborations ever coordinated by funding agencies, will be administered through UC San Francisco. Many of those who are affected by TBI are never diagnosed, according to UCSF neurosurgeon Geoffrey Manley, MD, PhD, a principal investigator for the grant who will serve as the U.S. research team’s primary liaison to the NIH. “Each year in the United States at least 1.7 million people seek medical attention for TBI,” Manley said. “It is a contributing factor in a third of all injury-related deaths.” Manley is chief of neurosurgery at the UCSF-affiliated San Francisco General Hospital, a Level-1 trauma center. 

 The award supports a team of U.S. researchers who are participating in the International Traumatic Brain Injury (InTBIR) Initiative, a collaborative effort of the European Commission (EC), the Canadian Institutes of Health Research (CIHR), the National Institutes of Health (NIH) and the U.S. Department of Defense (DOD). The Outcomes Core, responsible for developing the assessment methods that will be used to monitor patient recovery, will be based at Spaulding Rehabilitation Hospital and Massachusetts General Hospital. Joseph Giacino, PhD, director of Rehabilitation Neuropsychology at Spaulding, will serve as a principal investigator for the national consortium study and will lead the Outcomes Core. Ann-Christine Duhaime, MD, director of Neurosurgical Trauma and Intensive Care at Mass General will serve as the site leader and Ross Zafonte, DO, senior vice president of Medical Affairs, Research and Education at Spaulding, chief of Physical Medicine and Rehabilitation at Mass General and chair of the Department of Physical Medicine and Rehabilitation at Harvard Medical School, will serve as a co-investigator.

“This is the first truly global initiative dedicated to accelerating the pace of discovery around TBI. TRACK TBI-II will harness the wealth of knowledge we now have access to through imaging, laboratory and behavioral technologies to gain a better understanding of the relationship between specific injury profiles and treatment interventions most likely to be effective. I have every expectation that this international effort will favorably impact one of the most devastating public health problems of our time,” said Giacino. “The Mass General-Spaulding- Harvard team is honored to be part of this dynamic collaborative project and we look forward to our collective mission of improving the lives of people who experience TBI.”

The U.S. Centers for Disease Control and Prevention estimates that 2 percent of the U.S. population now lives with TBI-related disabilities, at an annual cost of about $77 billion. In Europe, an additional 2.5 million people suffer from TBI each year.

In the work funded by the NIH grant — which also is supported by contributions from the private sector and from the nonprofit One Mind for Research — the researchers aim to refine and improve diagnosis and treatment of TBI, which often has insidious health effects, and therefore is frequently undiagnosed, misdiagnosed, inadequately understood and undertreated, according to Manley. 

 New Approach to Lead to Patient-Specific Treatments

“After three decades of failed clinical trials, a new approach is needed,” Manley said. “We expect that our approach will permit researchers to better characterize and stratify patients, will allow meaningful comparisons of treatments and outcomes, and will improve the next generation of clinical trials. The work will advance our understanding of TBI and lead to more effective, patient-specific treatments.”

Since 2009 Manley and Pratik Mukherjee, MD, PhD, a professor of radiology and biomedical imaging at UCSF, have helped lay the groundwork for the continuing TBI research by leading the NIH-funded TRACK-TBI project, through which they and their research collaborators have demonstrated the value of gathering common data across research sites, including a standardized approach to imaging, clinical data, bio-specimens, and tracking outcomes. 

Already, TRACK-TBI researchers have made progress toward more useful classification and prognosis of TBI. Earlier this year they reported that cases of concussion, or TBI that are classified as “mild” by standard criteria but that show abnormalities on early magnetic resonance imaging (MRI) scans, are much more likely to have worse outcomes three months after the scan in comparison to cases in which scans reveal no abnormalities. Furthermore, the researchers found that elevated blood levels of a protein released during brain injury was associated with the likelihood of an abnormal CT scan. 

The new NIH award funds a continuation and expansion of TRACK-TBI. Among the goals is the creation of a widely accessible, comprehensive “TBI information commons” to integrate clinical, imaging, proteomic, genomic, and outcome biomarkers from subjects across the age and injury spectra. Another goal is to establish the value of biomarkers that will improve classification of TBI and better optimize selection and assignment of patients for clinical trials.

The researchers also aim to evaluate measures to assess patient outcomes across all phases of recovery and at all levels of TBI severity, to determine which tests, treatments, and services are effective and appropriate — depending on the nature of TBI in particular patients.

In addition to Manley and Mukherjee, principal investigators for the newly funded project include Claudia Robertson, MD, Baylor College of Medicine; Joseph Giacino, PhD, Harvard University; Ramon Diaz-Arrastia, MD, PhD, Uniformed Services University of the Health Sciences; David Okonkwo, MD, PhD, University of Pittsburgh; and Nancy Temkin, PhD, University of Washington.

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