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Hyperbaric oxygen for mTBI-associated PCS and PTSD: Pooled analysis of results from Department of Defense and other published studies

Background: Some clinical trials report improvement in persistent post-concussive symptoms (PCS) with hyperbaric oxygen (HBO2) following mild traumatic brain injury (mTBI), but questions remain regarding the utility of HBO2 for PCS, the effects of HBO2 on post-traumatic stress disorder (PTSD), and the influences of sham control exposures. Methods: A systematic review and pooled analysis was conducted to summarize available evidence for HBO2 in mTBI-associated PCS ± PTSD. Data aggregated from four Department of Defense (DoD) studies with participant-level data (n=254) were grouped into pooled HBO2 and sham intervention groups. Changes from baseline to post-intervention on PCS, PTSD, and neuropsychological measures ..

  08-07-2019

A composite outcome for mild traumatic brain injury in trials of hyperbaric oxygen

Introduction: Global outcomes can strengthen inferences from clinical trials. We evaluate global outcomes for persistent post-concussive symptoms (PCS) after mild traumatic brain injury (mTBI) in two clinical trials of hyperbaric oxygen (HBO2) in United States service members. Methods: During study design, outcomes of symptom, cognitive, and functional impairments planned for a trial of HBO2 for PCS (HOPPS) were weighted and grouped into different domains to formulate the composite outcome total score. The composite outcome was compared between the intervention groups in HOPPS and those in a subsequent HBO2 trial (BIMA) for validation. Additionally, two post hoc global outcome measures were ..

  08-07-2019

Adverse events and blinding in two randomized trials of hyperbaric oxygen for persistent post-concussive symptoms

Safety monitoring and successful blinding are important features of randomized, blinded clinical trials. We report chamber- and protocol-related adverse events (AEs) for participants enrolled in two randomized, double-blind clinical trials of hyperbaric oxygen (HBO2) for persistent post-concussive symptoms clinicaltrials.gov identifiers NCT01306968, HOPPS, and NCT01611194, BIMA), as well as the success of maintaining the blind with a low-pressure sham control arm. In both studies, participants were randomized to receive HBO2 (1.5 atmospheres absolute, >99% oxygen) or sham chamber sessions (1.2 atmospheres absolute, room air). In 143 participants undergoing 4,245 chamber sessions, chamber-related adverse events were rare (1.1% in the HOPPS ..

  08-07-2019

Extended follow-up in a randomized trial of hyperbaric oxygen for persistent post-concussive symptoms

To date, several Department of Defense (DoD) and civilian studies have evaluated hyperbaric oxygen for mild forms of traumatic brain injury. Prior to the DoD-sponsored “Brain Injury and Mechanisms of Action of Hyperbaric Oxygen for Persistent Post-Concussive Symptoms after Mild Traumatic Brain Injury (mTBI) (BIMA)” trial, none included post-intervention follow-up beyond three to six months. Post-hoc attempts at long-term follow-up were complicated by low participation and potential self-selection bias. BIMA planned for follow-up through 12 months but was amended to add post-concussive and post-traumatic stress disorder, quality of life, pain, depression, anxiety, and alcohol use assessments at 24 and ..

  08-07-2019

Eye tracker outcomes in a randomized trial of 40 sessions of hyperbaric oxygen or sham in participants with persistent post concussive symptoms

Purpose: Eye movements may offer a sensitive method to measure response to intervention in mild traumatic brain injury (mTBI). Methods: The Brain Injury and Mechanisms of Action of Hyperbaric Oxygen for Persistent Post-Concussive Symptoms after Mild Traumatic Brain Injury Study (BIMA) randomized 71 participants to 40 sessions of hyperbaric oxygen or sham. A companion normative study (Normal) enrolled 75 participants. An eye tracking system measured left and right eye movements for saccadic and smooth pursuit. At baseline two smooth pursuit tasks, circular and horizontal ramp, and four saccadic tasks, horizontal and vertical step, reading, and memory guided-on tasks differentiated BIMA ..

  08-07-2019

Analysis of magnetic resonance spectroscopy relative metabolite ratios in mild traumatic brain injury and normative controls

Introduction: We evaluated magnetic resonance spectroscopy (MRS) in United States military personnel with persistent symptoms after mild traumatic brain injury (mTBI), comparing over time two groups randomized to receive hyperbaric oxygen or sham chamber sessions and a third group of normative controls.  Methods: Active-duty or veteran military personnel and normative controls underwent MRS outcome measures at baseline, 13 weeks (mTBI group only), and six months. Participants received 3.0 Tesla brain MRS for analysis of water-suppressed two-dimensional (2D) multivoxel 1H-MRS of the brain using point resolved spectroscopy (PRESS) with volume selection localized above the lateral ventricles and within the brain parenchyma, ..

  08-07-2019

Prospective study of anxiety, post-traumatic stress and depression on postural control, gait, otolith and visuospatial function in military service members with persistent post-concussive symptoms

Purpose: Military service members often report both affective and vestibular complaints after mild traumatic brain injury (mTBI), but associations between symptoms and vestibular deficits can be subtle and inconsistent. Methods: From two complementary studies, one of military service members with persistent post-concussive symptoms after mTBI (NCT01611194) and the other of adult volunteers with no history of brain injury (NCT01925963), affective symptoms were compared to postural control, gait, otolith and visuospatial function. Results: The studies enrolled 71 participants with mTBI and 75 normative controls. Participants with mTBI had significantly reduced postural equilibrium on the sensory organization test (SOT), and more so in ..

  08-07-2019

Central auditory processing disorders after mild traumatic brain injury

Auditory processing disorders are common following mild traumatic brain injury (mTBI), but the neurocircuitry involved is not well understood. The present study used functional MRI to examine auditory cortex activation patterns during a passive listening task in a normative population and mTBI patients with and without clinical central auditory processing deficits (APD) as defined by the SCAN-3:A clinical battery. Patients with mTBI had overall patterns of lower auditory cortex activation during the listening tasks as compared to normative controls. A significant lateralization pattern (pairwise t-test; p<0.05) was observed in normative controls and in those with mTBI and APD during ..

  08-07-2019

Hidden hearing deficits in military service members with persistent post concussive symptoms

Introduction: Individuals with persistent symptoms after mild traumatic brain injury (mTBI) often have auditory complaints. In this study, we used the auditory brainstem response (ABR) to determine whether cochlear synaptopathy could explain auditory symptoms.  Methods: 69 adult military service members with mTBI and 25 adults without brain injury (NCT01611194 and NCT01925963) completed pure-tone audiometry, ABR, and central auditory processing tests. All participants were male, ages 21-50. Results: 37/69 mTBI participants had measurable hearing loss, while another 20-30% had hearing complaints or tinnitus. While mTBI participants with measurable hearing loss had reduced wave I and III amplitude and decreased III-V interpeak latency, ..

  08-07-2019

Quantitative analysis tool for clinical functional MRI in mild traumatic brain injury

Functional magnetic resonance imaging (fMRI) has been available commercially for clinical diagnostic use for many years. However, both clinical interpretation of fMRI by a neuroradiologist and quantitative analysis of fMRI data can require significant personnel resources that exceed reimbursement. In this report, a fully automated computerbased quantification methodology (Enumerated Auditory Response, EAR) has been developed to provide an auditory fMRI assessment of patients who have suffered a mild traumatic brain injury. Fifty-five study participants with interpretable auditory fMRI sequence data were assessed by EAR analysis, as well as both clinical radiologist fMRI interpretation and voxelwise general linear model (GLM) ..

  08-07-2019

Reference ranges and stability of auditory and vestibular measures in a comprehensive assessment battery for traumatic brain injury

Background: Audiology clinics have many tools available to evaluate auditory and vestibular complaints. However, many tools lack established normative ranges across the life span. We conducted this study to establish reference ranges across the life span for audiology/ vestibular measures commonly used to evaluate patients with traumatic brain injury. Materials and Methods: In this repeated measures study, 75 adults, ages 18-65 years, without a history of traumatic brain injury, underwent robust auditory/vestibular evaluations three times over six months, including rotational chair, videonystagmography, computerized dynamic posturography, vestibular evoked myogenic potentials, and retinal fundoscopy. Results: Age effect was notable for transient evoked otoacoustic ..

  08-07-2019

Executive summary: Secondary analyses of DoD-sponsored studies examining hyperbaric oxygen for persistent post-concussive symptoms after mild traumatic brain injury

Traumatic brain injury (TBI) is a major cause of death and disability in the United States (U.S.), with the Centers for Disease Control and Prevention reporting approximately 2.8 million TBI-related emergency department visits, hospitalizations, and deaths in 2012 [1]. For those under 45 years of age, TBI is the number one cause of disability and mortality worldwide [2]. Within military populations TBI remains especially problematic. While the incidence of TBI in the U.S. military peaked in 2011, Department of Defense personnel continue to experience approximately 18,000 new cases each year, with 383,473 total cases between 2000 and the first ..

  08-07-2019


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