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Open Studies

Spaulding-Harvard Traumatic Brain Injury Model System

The Spaulding-Harvard Traumatic Brain Injury Model System (SH-TBIMS) is one of 16 centers in the nation selected by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) to receive federal funding for research on TBI for the 2017-2022 funding cycle. As a TBI Model System, the SH-TBIMS contributes data to the TBIMS National Database study, conducts a site-specific project, and leads and participates in multi-center module studies with other TBI Model System centers.

For further information about the Spaulding-Harvard TBI Model System and its research, dissemination, and clinical programs, click here

 

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

This 18-site investigation funded by the National Institutes of Health (NIH) aims to identify TBI “phenotypes” by acquiring clinical, neuroimaging and biomarker data on 3,000 persons with mild to severe TBI, and two comparison groups without brain injury. Ultimately, data collected in TRACK-TBI will aid in the determination of which tests, treatments, services, and classifications are effective and appropriate for which TBI. TRACK-TBI-II is the largest study of TBI funded to date by NIH.

The Neurorehabilitation Laboratory serves as the national Outcomes Core for the TRACK-TBI-II study. The approach to outcome assessment employed in TRACK-TBI was designed by our lab with the goal of ensuring that multiple outcome domains (e.g. physical, cognitive, psychological, social) are captured and tracked across all phases of recovery.

For more information about the TRACK-TBI-II study, please visit https://tracktbi.ucsf.edu

 

Traumatic Brain Injury Endpoint Development (TED) Initiative

TBI is a multifaceted condition, and as of 2015, no drug or device has been approved by the U.S. Food and Drug Administration (FDA) to treat acute TBI. TED researchers are examining existing datasets from thousands of athletes, soldiers and the broader population to identify which current measures are most effective, and validate these measures or “endpoints” of brain injury and recovery. The TED team is comprised of leading academic clinician-scientists, industry leaders in biotechnology and imaging technology, patient advocacy organizations, and philanthropies. The lead site is the University of California, San Francisco. The SRH Neurorehabilitation Laboratory co-leads the Outcomes Core for the TED Initiative.

First among TED’s objectives is to establish a TED Metadataset consisting of integrated clinical outcomes, and imaging, proteomic, and genomic data, from ongoing and legacy TBI studies across civilian, military, and sports cohorts. This highly detailed and multi-scalar repository will be continuously curated and analyzed using conventional and novel methodologies. TED researchers aim to identify and validate meaningful TBI endpoints, as well as structural abnormalities that may be predictive of outcomes, making strides toward a new taxonomy for TBI.

For more information about the TRACK-TBI-II study, please visit https://tbiendpoints.ucsf.edu

 

Central Thalamic Stimulation for Traumatic Brain Injury

Traumatic brain injury (TBI) afflicts hundreds of thousands of Americans each year, producing chronic cognitive disabilities that lack effective treatment. Preliminary studies with TBI patients and non-human primates suggest that these cognitive disabilities may be due to disrupted circuit function in the brain, specifically involving impaired connections between the thalamus and the frontal cortex. This first-in-man early clinical feasibility study funded by the NIH-NINDS BRAIN Initiative is testing the use of central thalamic deep brain stimulation (CT-DBS) as a potential treatment for chronic cognitive impairment after severe to moderate traumatic brain injury. CT-DBS will be tested as a therapy for the survivors of moderate to severe TBI who recover to independent functional levels but remain significantly limited in their activities by chronic cognitive impairment (difficulties with sustained attentional effort, working memory, processing speed and fatigue). We hope to obtain a variety of behavioral and electrophysiological data to inform development of a next-generation device therapy for cognitive impairment associated with TBI. This study is led by Nicholas Schiff, MD (Weill Cornell Medical College), Joseph Giacino, PhD (Spaulding Rehabilitation Hospital), Christopher Butson, PhD (University of Utah), Jaimie Henderson, MD (Stanford University), and Andre Machado, MD, PhD (Cleveland Clinic).