Wright Brittany, Guilliod Renie, Thakur Bhaskar, Kundig Charles, Morales Jill, Tessler Joseph, Berry James, Zhang Rong, Bell Kathleen R, Pinto Shanti M
Department of Physical Medicine and Rehabilitation, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Contemp Clin Trials Commun. 2023 Jun 20;34:101176. doi: 10.1016/j.conctc.2023.101176. eCollection 2023 Aug.
Post-Concussion Syndrome (PCS) refers to the persistence of physical, cognitive, and emotional symptoms following mild traumatic brain injury (mTBI)/concussion, occurring in roughly 15-30% of individuals. Hyperbaric oxygen therapy (HBOT) has been suggested as a potential treatment for PCS; however, the evidence to date is mixed due to inconsistencies in the treatment protocol and focus on veterans with combat-related injuries, which may not be generalizable to the general population. The goal of Hyperbaric Oxygen Therapy for Post-Concussion Syndrome (HOT-POCS) is to assess the efficacy and safety of HBOT for the treatment of PCS in the civilian population. This randomized, controlled pilot study will be using a standardized HBOT protocol (20 sessions of 100% O at 2.0 atm absolute [ATA]) compared with a true placebo gas system that mimics the oxygen composition at room air (20 sessions of 10.5% O and 89.5% nitrogen at 2.0 ATA) in a cohort of 100 adults with persistent post-concussive symptoms 3-12 months following injury. Change in symptoms on the Rivermead Post-concussion Questionnaire (RPQ) will be the primary outcome of interest. Secondary outcomes include the rate of adverse events, change in the quality of life, and change in cognitive function. Exploratory outcome measures will include changes in physical function and changes in cerebral brain perfusion and oxygen metabolism on MRI brain imaging. Overall, the HOT-POCS study will compare the efficacy of a standardized HBOT treatment protocol against a true placebo gas for the treatment of PCS within 12 months after injury.
脑震荡后综合征（PCS）是指轻度创伤性脑损伤（mTBI）/脑震荡后身体、认知和情绪症状的持续存在，约15%-30%的个体出现这种情况。高压氧疗法（HBOT）已被提议作为PCS的一种潜在治疗方法；然而，由于治疗方案不一致以及研究重点是与战斗相关损伤的退伍军人，目前的证据好坏参半，这些结果可能无法推广到普通人群。脑震荡后综合征高压氧治疗（HOT-POCS）的目标是评估HBOT治疗普通人群中PCS的疗效和安全性。这项随机对照试验性研究将采用标准化的HBOT方案（在2.0绝对大气压[ATA]下进行20次100%氧气治疗），并与一个真正的安慰剂气体系统进行比较，该安慰剂气体系统模拟室内空气中的氧气成分（在2.0 ATA下进行20次10.5%氧气和89.5%氮气治疗），研究对象为100名在受伤后3-12个月仍有持续性脑震荡后症状的成年人。Rivermead脑震荡后问卷（RPQ）上症状的变化将是主要关注的结果。次要结果包括不良事件发生率、生活质量变化和认知功能变化。探索性结果指标将包括身体功能变化以及MRI脑成像上脑灌注和氧代谢的变化。总体而言，HOT-POCS研究将比较标准化HBOT治疗方案与真正的安慰剂气体在受伤后12个月内治疗PCS的疗效。
