Weaver Lindell K, Chhoeu Austin, Lindblad Anne S, Churchill Susan, Wilson Steffanie H
Division of Hyperbaric Medicine Intermountain Medical Center, Murray, Utah, and Intermountain LDS Hospital, Salt Lake City, Utah U.S.
University of Utah School of Medicine, Salt Lake City, Utah U.S.
Undersea Hyperb Med. 2016 Aug-Sept;43(5):491-509.
The Brain Injury and Mechanisms of Action of Hyperbaric Oxygen for Persistent Post-Concussive Symptoms after Mild Traumatic Brain Injury (mTBI) (BIMA) study, sponsored by the Department of Defense, is a randomized double-blind, sham-controlled clinical trial that has a longer duration of follow-up and more comprehensive assessment battery compared to recent HBO₂ studies. BIMA randomized 71 participants from September 2012 to May 2014. Primary results are expected in 2017. Randomized military personnel received hyperbaric oxygen (HBO₂) at 1.5 atmospheres absolute (ATA) or sham chamber sessions at 1.2 ATA, air, for 60 minutes daily for 40 sessions. Outcomes include neuropsychological, neuroimaging, neurological, vestibular, autonomic function, electroencephalography, and visual systems evaluated at baseline, immediately following intervention at 13 weeks and six months with self-report symptom and quality of life questionnaires at 12 months, 24 months and 36 months. Characteristics include: median age 33 years (range 21-53); 99% male; 82% Caucasian; 49% diagnosed post-traumatic stress disorder; 28% with most recent injury three months to one year prior to enrollment; 32% blast injuries; and 73% multiple injuries. This manuscript describes the study design, outcome assessment battery, and baseline characteristics. Independent of a therapeutic role of HBO₂, results of BIMA will aid understanding of mTBI.
ClinicalTrials.gov Identifier: NCT01611194; https://clinicaltrials.gov/show/NCT01611194.
由国防部资助的“轻度创伤性脑损伤（mTBI）后持续性脑震荡后症状的脑损伤与高压氧作用机制（BIMA）研究”是一项随机双盲、假对照临床试验，与近期的高压氧（HBO₂）研究相比，其随访时间更长，评估项目更全面。BIMA在2012年9月至2014年5月期间将71名参与者进行了随机分组。主要结果预计在2017年得出。随机分组的军事人员接受绝对压力1.5个大气压（ATA）的高压氧（HBO₂）治疗或在1.2 ATA的空气中进行假舱治疗，每天60分钟，共40次治疗。评估指标包括在基线时、干预后13周和6个月时进行的神经心理学、神经影像学、神经学、前庭、自主神经功能、脑电图和视觉系统评估，以及在12个月、24个月和36个月时通过自我报告症状和生活质量问卷进行评估。参与者特征包括：年龄中位数33岁（范围21 - 53岁）；99%为男性；82%为白种人；49%被诊断患有创伤后应激障碍；28%在入组前三个月至一年有最近一次损伤；32%为爆炸伤；73%为多处损伤。本手稿描述了研究设计、结果评估项目和基线特征。无论HBO₂是否具有治疗作用，BIMA的结果都将有助于对mTBI的理解。
ClinicalTrials.gov标识符：NCT01611194；https://clinicaltrials.gov/show/NCT01611194 。
