USAMMDA and Funded Partnering Organizations Release First Publication in Series Detailing Potential TBI Clinical Endpoints
U.S. Army Medical Materiel Development Activity Public Affairs Office
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US Army Medical Materiel Develovment Activity
For Immediate Release -- October 31, 2016
Fort Detrick, Md. - The U.S. Army Medical Materiel Development Activity, a subordinate command of the U.S. Army Medical Research and Materiel Command, has announced that its group of contract research partners, which includes the Emmes Corporation in Rockville, Maryland; LDS Hospital in Salt Lake City, Utah; and Lovelace Biomedical Environmental Research Institute in Albuquerque, New Mexico, have authored a series of papers summarizing significant research on mild Traumatic Brain Injury, or mTBI, in the military. These papers, which detail findings from three Department of Defense-sponsored studies, were published in a special edition of the Undersea and Hyperbaric Medical Society (www.uhms.org) Journal released this month.
Beyond providing additional, objectively controlled study data describing hyperbaric oxygen, or HBO2, effects in mTBI, these studies are intended to provide an innovative set of physiologic and neuroimaging outcome measures that will advance both the DOD and non-military medical communities' ability to identify and develop new treatments for mTBI.
The three studies, initiated in 2012, 2013 and 2014, respectively, are specifically identified as "Brain Injury and Mechanisms of Hyperbaric Oxygen for Persistent Post-Concussive Symptoms after Mild Traumatic Brain Injury" (BIMA), "Development of Normative Datasets for Assessments Planned for Use in Patient with Mild Traumatic Brain Injury" (Normal), and "Long-term Follow-up of Participants Receiving Hyperbaric Oxygen or Post-Concussion Syndrome" (Long-term Follow-up). Sponsored by the DOD, these studies addressed both active duty and veterans in the military who suffer from persistent post-concussive symptoms after mTBI.
The USAMMDA Hyperbaric Oxygen Research Project Management Office serves as project manager for these studies. Along with a diverse team of USAMMDA support staff, representatives of the HBO2 PMO who have led efforts to secure the research approval and support necessary to conduct these mTBI projects include Col. Scott Miller, Col. Austin Chhoeu, Capt. Leonard Skipper, all members of the U.S. Army, U.S. Navy Capt. Brett Hart, and Michael Husband, Neurotrauma and Psychological Health project manager. Despite the complex design of these studies, the HBO2 PMO led numerous Contract Research Organizations in bringing these studies to fruition.
Hart, current HBO2 PMO project manager, said, "The success of our BIMA, Normal, and Long-term Follow-up research has been largely dependent on our ability to support the coordinated, collegial efforts of our expert research teams. Their accomplished performance and cooperation over the past four years have been nothing short of remarkable."
Dr. Anne Lindblad, biostatistician and Emmes president and chief executive officer, and Dr. Steffanie Wilson, Emmes biostatistician, collaborated with principal investigator Dr. Lindell Weaver of the Hyperbaric Medicine Department of LDS Hospital, as well as Susan Churchill and Kayla Deru, also of LDS Hospital in conducting the study that produced the results from the TBI research.
"These papers addressed the baseline findings of one of the most complex clinical trials of HBO2, which is being investigated as a potential intervention for post-concussive symptoms following mTBI in a military population," said Weaver.
Wilson explained that the BIMA and Normal studies differ from the DOD-sponsored studies previously performed, both in terms of having a longer duration of participant follow-up and use of a more comprehensive suite of assessments, including an array of visual, audiological, neurological, neuropsychological and neuroimaging tests.
"The papers we wrote for the UHM Journal addressed baseline data from the clinical trial," said Wilson. "We appreciate the combined efforts of the study team and all of the authors of the papers. We expect to produce a series of additional manuscripts on post-intervention findings."
While the results released in UHM journal special edition primarily detail study baseline findings, the HBO2 PMO continues to work with its Emmes, LSD Hospital and Lovelace partners to complete the ongoing BIMA and Normal study data analysis and report finalization.
"Once complete, the scientific value of these studies to the field of TBI management is potentially unlimited," said Hart.
To date, few, if any, U.S. Food and Drug Administration-regulated TBI studies have incorporated the breadth of outcome measures these trials assessed, or provided the concurrent opportunity to validate the same measures through direct comparison to a normal population control.
"Although the BIMA and Normal study efforts are coming to a close, there are still more questions that must be answered regarding the effects of HBO2 on mTBI, post-concussive symptoms and post-traumatic stress disorder," said Hart.
Regardless of the research challenges that lie ahead, Hart remains confident that USAMMDA and the HBO2 PMO team will continue to be a DOD leader in developing and delivering validated, effective baromedical solutions to the Warfighter and the medical community at large.
The UHM Journal is a special publication. The online version of the publication will be available to members, but there will be a limited print run that will be available for purchase from UHMS through its website at www.uhms.org.