Randomized, controlled clinical trial of acoustic stimulation to reduce postconcussive symptoms.

OBJECTIVE: Effective interventions are needed to address postconcussive symptoms. We report the results of randomized, sham-controlled trial of Cereset Research™ Standard Operating Procedures (CR-SOP), a noninvasive, closed-loop, allostatic, acoustic stimulation neurotechnology previously shown to improve insomnia. METHODS: Military service members, veterans, or their spouses with persistent symptoms (Neurobehavioral Symptom Inventory [NSI] Score ≥23) after mTBI 3 months to 10 years ago, were randomized to receive 10 sessions of engineered tones linked to brainwaves (LB, intervention), or random engineered tones not linked to brainwaves (NL, sham control). The primary outcome was change in NSI, with secondary outcomes of heart rate variability and self-report measures of sleep, mood, and anxiety. RESULTS: Participants (n = 106, 22% female, mean age 37.1, 2.8 deployments, 3.8 TBIs) were randomized 1:1 to LB or NL, with no significant differences between groups at baseline. Among all study participants, the NSI declined from baseline 41.0 to 27.2 after (P < 0.0001), with gains largely sustained at 3 months (31.2) and 6 months (28.4). However, there were no significant differences between the LB (NSI declined from 39.9 at baseline to 28.2 post-intervention, 31.5 at 3 months, and 29.4 at 6 months) and NL (NSI declined from 41.5 at baseline to 26.2, 29.9, and 27.3, respectively. Similar patterns were observed for the PCL5 and PHQ-9 and there was no difference in HRV between groups. INTERPRETATION: Ten hours of acoustic stimulation while resting in a zero-gravity chair improves postconcussive symptoms. However, linking tones to brain electrical activity did not reduce symptoms more than random tones. REGISTRATION: ClinicalTrials.gov - NCT03649958.

Virtual reality and haptic interfaces for civilian and military open trauma surgery training: A systematic review.

OBJECTIVE: Virtual (VR), augmented (AR), mixed reality (MR) and haptic interfaces make additional avenues available for surgeon assessment, guidance and training. We evaluated applications for open trauma and emergency surgery to address the question: Have new computer-supported interface developments occurred that could improve trauma training for civilian and military surgeons performing open, emergency, non-laparoscopic surgery? DESIGN: Systematic literature review. SETTING AND PARTICIPANTS: Faculty, University of Maryland School of Medicine, Baltimore., Maryland; Womack Army Medical Center, Fort Bragg, North Carolina; Temple University, Philadelphia, Pennsylvania; Uniformed Services University of Health Sciences, and Walter Reed National Military Medical Center, Bethesda, Maryland. METHODS: Structured literature searches identified studies using terms for virtual, augmented, mixed reality and haptics, as well as specific procedures in trauma training courses. Reporting bias was assessed. Study quality was evaluated by the Kirkpatrick's Level of evidence and the Machine Learning to Asses Surgical Expertise (MLASE) score. RESULTS: Of 422 papers identified, 14 met inclusion criteria, included 282 enrolled subjects, 20% were surgeons, the remainder students, medics and non-surgeon physicians. Study design was poor and sample sizes were low. No data analyses were beyond descriptive and the highest outcome types were procedural success, subjective self-reports, except three studies used validated metrics. Among the 14 studies, Kirkpatrick's level of evidence was level zero in five studies, level 1 in 8 and level 2 in one. Only one study had MLASE Score greater than 9/20. There was a high risk of bias in 6 studies, uncertain bias in 5 studies and low risk of bias in 3 studies. CONCLUSIONS: There was inadequate evidence that VR,MR,AR or haptic interfaces can facilitate training for open trauma surgery or replace cadavers. Because of limited testing in surgeons, deficient study and technology design, risk of reporting bias, no current well-designed studies of computer-supported technologies have shown benefit for open trauma, emergency surgery nor has their use shown improved patient outcomes. Larger more rigorously designed studies and evaluations by experienced surgeons are required for a greater variety of procedures and skills. COMPETENCIES: Medical Knowledge, Practice Based Learning and Improvement, Patient Care, Systems-Based Practice.

Augmented Reality Forward Damage Control Procedures for Nonsurgeons: A Feasibility Demonstration.

INTRODUCTION: This article presents an emerging capability to project damage control procedures far forward for situations where evacuation to a formal surgical team is delayed. Specifically, we demonstrate the plausibility of using a wearable augmented reality (AR) telestration device to guide a nonsurgeon through a damage control procedure. METHODS: A stand-alone, low-profile, commercial-off-the-shelf wearable AR display was utilized by a remotely located surgeon to synchronously guide a nonsurgeon through proximal control of the distal external iliac artery on a surgical manikin. The manikin wound pattern was selected to simulate a rapidly exsanguinating junctional hemorrhage not controllable by nonsurgical means. RESULTS: This capability demonstration displayed successful use of AR technology, telecommunication, and procedural training and guidance in a single test pilot. The assisted physician assistant was able to rapidly control the simulated external iliac artery injury on this model. The telestration system used was commercially available for use with available civilian cell phone, wireless and satellite networks, without the need for dedicated high-speed networks. CONCLUSIONS: A nonsurgeon, using a wearable commercial on-visual-axis telestration system, successfully performed a damage control procedure, demonstrating the plausibility of this approach.

Combined congenital radial and ulnar longitudinal deficiencies: report of 2 cases.

Variation in longitudinal deficiencies is likely related to the timing and duration of an insult during early limb development. In experimental models, teratogenic insults induce ulnar deficiencies earlier in gestation than radial deficiencies. In this report, we describe the rare combination of right radial and left ulnar deficiencies in 2 cases. Interestingly, 1 case had a history of 2 separate and apparently distinct episodes of bleeding during early gestation, whereas the other demonstrated associated hematoma formation early in development. These cases also demonstrate the susceptibility for ulnar defects on the left and radial defects on the right. The authors discuss the relationship of prenatal insults on limb development and the mechanisms underlying longitudinal deficiencies.