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.
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.
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.
View Article and Find Full Text PDFPurpose: 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.
Undersea Hyperb Med
November 2019
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.
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.
View Article and Find Full Text PDFBackground: Dizziness and imbalance are common after mild traumatic brain injury (mTBI). Hyperbaric oxygen (HBO2) has been proposed for persistent post-concussive symptoms after mTBI, but its effect on vestibular function is unknown.
Objective: To describe balance function in military service-members before and after intervention, and to explore the influence of post-traumatic stress disorder (PTSD), anxiety, and depression on vestibular outcomes.
Study Objective: In this exploratory, double-blind, longitudinal sham-controlled trial of hyperbaric oxygen (HBO) for military personnel with post concussive mild traumatic brain injury (mTBI), self-reports and objective measures of sleep-wake disturbances were assessed and compared to normals.
Methods: Self-reports consisting of Pittsburg Sleep Quality Index (PSQI), sleep diary, screening for obstructive sleep apnea (OSA) risk, restless legs syndrome (RLS), cataplexy, and objective actigraphic measures of sleep-wake were obtained on 71 military personnel with mTBI [baseline, 13 weeks and six months post-randomization (post-intervention)], of which 35 met post-traumatic stress disorder (PTSD) criteria, and 75 healthy volunteers (baseline). Baseline between-group and follow-up changes from baseline overall and within subgroups were evaluated.
Dermatomyositis is a life-altering inflammatory disorder of skin and muscle. Details regarding the natural course of this disorder, the effects of specific therapies on its progression, and the optimal therapeutic dosage and duration of prednisone are limited. We performed a retrospective medical record review of dermatomyositis patients at four medical centers.
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