DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

TEAM-TBI: a Precision Medicine Approach for TBI

Posted July 14, 2017

David O. Okonkwo, M.D., Ph.D., University of Pittsburgh

David O. Okonkwo, M.D., Ph.D.
David O. Okonkwo, M.D., Ph.D.

In addition to the millions of US civilians diagnosed with traumatic brain injury (TBI) each year, the Defense and Veterans Brain Injury Center (DVBIC) reports that over 360,000 Service members have suffered TBIs since the year 2000. There are currently no US Food and Drug Administration (FDA)-approved pharmaceutical interventions for TBI, and there is little consensus regarding the effectiveness of cognitive rehabilitation strategies for TBI patients. Due to the heterogeneous nature of these injuries, there is a strong need to develop protocols for identifying the specific problems and complications of individuals suffering from chronic TBI symptoms. This type of clinically actionable information could guide targeted therapies for patients, leading to improved cognitive function and decreased symptoms following TBI. In response to a Broad Agency Announcement released by the Psychological Health and Traumatic Brain Injury Program in 2013, Dr. David Okonkwo at the University of Pittsburgh is currently leading a clinical trial of adult patients with a history of TBI or blast exposure for the Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury (TEAM-TBI). The goal of TEAM-TBI is to determine efficacious targeted therapies for TBI patients and provide deployable protocols and technology for large-scale, cost-effective diagnostics and management tools.

Since 2014, Dr. Okonkwo’s team has been focused on recruiting TBI patients to the main clinical site at the University of Pittsburgh. A total of 94 patients have been enrolled in the TEAM-TBI clinical trial, 60 of which have completed treatment and follow-up with an additional 24 undergoing treatment (4 patients have withdrawn and 6 were lost to follow-up). Upon enrollment, a comprehensive 3-day intake evaluation is used to assess the clinical trajectories of TBI patients, as well as the heterogeneity of the injury, in order to guide targeted therapy strategies. The patients are then stratified into clinical TBI trajectories, which include psychological health, sleep disruption, cognitive impairment, oculomotor disturbance, vestibular impairment, and post-traumatic headache. Extensive neuroimaging and biomarker data are also collected during the intake evaluation. The University of Pittsburgh Medical Center (UPMC) Sports Medicine Concussion Program conducts initial and follow-up assessments of the patients, including thorough evaluations by a neuropsychologist, vestibular therapist, and physical therapist in order to make recommendations for treatment. Following the evaluations and clinical interviews, the UPMC Sports Medicine Concussion Program providers prescribe participants psychological, vestibular, oculomotor, and exertional in-home therapies for deficiencies identified during their clinical visit. A TEAM-TBI Toolkit is provided, which includes the materials for the 6-month targeted treatment. Interventions administered through this novel telemedicine treatment modality can include activity and sleep monitoring, personal coaching, and mindfulness and cognitive training. A 6-month follow-up assessment is then conducted to compare the effectiveness of the treatment regimens in each individual patient. Based on the Post-Concussive Symptom Scale (PCSS), symptoms decreased 51.1% between screening and 6-month follow-up in the first 60 TEAM-TBI patients who completed treatment. The PCSS is a self-reported survey that rates 22 symptoms of concussive injuries, including dizziness, vomiting, and memory loss. Results in the form of abstracts have been accepted for oral and poster presentations at the Military Health System Research Symposium to be held in Kissimmee, Florida, from 27-30 August 2017.

Over the remaining year of the award, military partner sites will be added to the TEAM-TBI effort. Civilian and military TBI patients will undergo standard TBI evaluation and management processes, after which selected patients may be referred to the University of Pittsburgh to undergo a comprehensive TEAM-TBI evaluation and intervention. Notably, full datasets from the initial clinical study have been uploaded to the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system for the first 50 participants. Dr. Okonkwo’s team has a detailed schedule to maintain data entry efforts to the FITBIR system. TEAM-TBI will also continue to advance targeted telemedicine treatment modalities for TBI patients who suffer chronic symptoms. Dr. Okonkwo is actively seeking funding sources to expand these clinical trials, and has a waiting list of 30+ patients who have agreed to be contacted for future chronic TBI studies. Dr. Okonkwo’s efforts will disseminate the understanding that TBI is treatable, and the TEAM-TBI approach can positively impact both civilian and military TBI populations by guiding targeted therapies for improving cognitive function and decreasing symptoms.

Links:

Technical Abstract: TEAM-TBI

Clinical Trial Information: TEAM-TBI

TEAM-TBI Website:http://www.team-tbi.com/

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Last updated Friday, July 14, 2017