Elbin R J, Trbovich Alicia, Womble Melissa N, Mucha Anne, Fedor Sheri, Stephenson Katie, Holland Cyndi, Dollar Christina, Sparto Patrick, Durfee Kori, Patterson Charity G, Smith Clair N, Huppert Theodore J, Okonkwo David O, Collins Michael W, Kontos Anthony P
Office for Sport Concussion Research, Department of Health, Human Performance and Recreation, University of Arkansas, Fayetteville, AR, United States.
UPMC Sports Medicine Concussion Program, Department of Orthopaedic Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.
Front Neurol. 2023 Jun 30;14:1085662. doi: 10.3389/fneur.2023.1085662. eCollection 2023.
Mild traumatic brain injury (mTBI) affects ~18,000 military personnel each year, and although most will recover in 3-4 weeks, many experience persisting symptoms and impairment lasting months or longer. Current standard of care for U.S. military personnel with complex mTBI involves initial (<48 h) prescribed rest, followed by behavioral (e.g., physical activity, sleep regulation, stress reduction, hydration, nutrition), and symptom-guided management. There is growing agreement that mTBI involves different clinical profiles or subtypes that require a comprehensive multidomain evaluation and adjudication process, as well as a targeted approach to treatment. However, there is a lack of research examining the effectiveness of this approach to assessing and treating mTBI. This multisite randomized controlled trial (RCT) will determine the effectiveness of a targeted multidomain (T-MD) intervention (anxiety/mood, cognitive, migraine, ocular, vestibular; and sleep, autonomic) compared to usual care (behavioral management) in military-aged civilians with complex mTBI.
This study employs a single-blinded, two-group repeated measures design. The RCT will enroll up to 250 military-aged civilians (18-49 yrs) with a diagnosed complex mTBI within 8 days to 6 months of injury from two concussion specialty clinics. The two study arms are a T-MD intervention and a usual care, behavioral management control group. All participants will complete a comprehensive, multidomain clinical evaluation at their first clinical visit. Information gathered from this evaluation will be used to adjudicate mTBI clinical profiles. Participants will then be randomized to either the 4-week T-MD or control arm. The T-MD group will receive targeted interventions that correspond to the patient's clinical profile (s) and the control group will receive behavioral management strategies. Primary outcomes for this study are changes from enrollment to post-intervention on the Neurobehavioral Symptom Inventory (NSI), Patient Global Impression of Change (PGIC), and functional near-infrared spectroscopy (fNIRS). Time to return to activity (RTA), and healthcare utilization costs will also be assessed.
Study findings may inform a more effective approach to treat complex mTBI in military personnel and civilians, reduce morbidity, and accelerate safe return-to-duty/activity.
The study is approved by the University of Pittsburgh Institutional Review board and registered at clinicaltrials.gov. Dissemination plans include peer-reviewed publications and presentations at professional meetings.
www.clinicaltrials.gov, identifier: NCT04549532.
轻度创伤性脑损伤（mTBI）每年影响约18000名军事人员，尽管大多数人将在3 - 4周内康复，但许多人会经历持续数月或更长时间的症状和功能障碍。美国患有复杂性mTBI的军事人员目前的护理标准包括最初（<48小时）规定的休息，随后是行为（如体育活动、睡眠调节、减压、补水、营养）和症状引导管理。越来越多的人认为，mTBI涉及不同的临床特征或亚型，需要全面的多领域评估和判定过程，以及有针对性的治疗方法。然而，缺乏研究来检验这种评估和治疗mTBI方法的有效性。这项多中心随机对照试验（RCT）将确定在患有复杂性mTBI的军事年龄平民中，与常规护理（行为管理）相比，针对性多领域（T - MD）干预（焦虑/情绪、认知、偏头痛、眼部、前庭；以及睡眠、自主神经）的有效性。
本研究采用单盲、两组重复测量设计。该RCT将从两家脑震荡专科诊所招募多达250名军事年龄平民（18 - 49岁），他们在受伤后8天至6个月内被诊断为复杂性mTBI。两个研究组分别是T - MD干预组和常规护理行为管理对照组。所有参与者将在首次临床就诊时完成全面的多领域临床评估。从该评估中收集的信息将用于判定mTBI临床特征。然后，参与者将被随机分配到4周的T - MD组或对照组。T - MD组将接受与患者临床特征相对应的针对性干预，对照组将接受行为管理策略。本研究的主要结局是从入组到干预后在神经行为症状量表（NSI）、患者总体变化印象（PGIC）和功能性近红外光谱（fNIRS）方面的变化。恢复活动时间（RTA）和医疗保健利用成本也将进行评估。
研究结果可能为治疗军事人员和平民复杂性mTBI提供更有效的方法，降低发病率，并加速安全返回工作/活动岗位。
该研究已获得匹兹堡大学机构审查委员会的批准，并在clinicaltrials.gov上注册。传播计划包括同行评审出版物和在专业会议上的报告。
