The National Brain Injury Rescue and Rehabilitation Study - a multicenter observational study of hyperbaric oxygen for mild traumatic brain injury with post-concussive symptoms

Abstract

The National Brain Injury Rescue and Rehabilitation Project was established as a preliminary study to test the safety and practicality of multi-center hyperbaric oxygen administration for the post-concussive symptoms of chronic mild traumatic brain injury as a precursor to a pivotal, independent, multi-center, controlled clinical trial. This report presents the results for 32 subjects who completed a preliminary trial of hyperbaric oxygen several years before the passage of the 21 st Century Cures Act . This study anticipated the Act and its reassessment of clinical research. Subjects received 40–82 one-hour treatments at 1.5 atmospheres absolute 100% oxygen. Outcome measures included repeated self-assessment measures and automated neurocognitive tests. The subjects demonstrated improvement in 21 of 25 neurocognitive test measures observed. The objective neurocognitive test components showed improvement in 13 of 17 measures. Earlier administration of hyperbaric oxygen post injury, younger age at the time of injury and hyperbaric oxygen administration, military status, and increased number of hyperbaric oxygen administrations were characteristics associated with improved outcomes. There were no adverse events. Hyperbaric oxygen was found to be safe, inexpensive and worthy of clinical application in the 21 st Century model of facile data collection provided by recent research regulatory shifts in medicine. The study was approved by the ethics review committee of the Western Institutional Review Board (WIRB® Protocol #20090761).

Functional MRI (fMRI) Evaluation of Hyperbaric Oxygen Therapy (HBOT) Efficacy in Chronic Cerebral Stroke: A Small Retrospective Consecutive Case Series

“…Our preliminary results confirm the effectiveness of HBOT in improving the clinic of cerebral stroke Pts [ 24 , 26 ]. We believe that the association of HBOT with rehabilitation physiotherapy and speech therapy is the most effective way to improve neurological symptoms [ 20 ].…”

“…The ECHM document is from 2016. In the meantime, many papers [ 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 ] have been published in favour of HBOT, so that its level of evidence may have been increased.…”

“…Some papers [ 24 , 27 , 28 ] reported that HBOT is able to stimulate neuroplasticity even years after a brain insult.…”

Hyperbaric oxygen therapy for mild traumatic brain injury persistent postconcussion syndrome: a randomized controlled trial

“…HBOT has been applied to chronic TBI in animals and humans since 1989 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 with apparent conflicting results. 25 27 Various researchers have attributed the different results in mTBI PPCS to mischaracterized sham groups/the effects of different doses of HBOT, 11 12 24 42 43 44 45 46 47 design differences, 48 (small sample size, dissimilar outcome measures/populations/sites/protocol adherence, non-equivalence of group, selection bias), 29 ritual experience, 28 and placebo/Hawthorne effects.…”

Therapeutic Effects of Meditation, Yoga, and Mindfulness‐Based Interventions for Chronic Symptoms of Mild Traumatic Brain Injury: A Systematic Review and Meta‐Analysis

“…Untreated brain injuries are considered to be the most expensive public health problem in the world (Mozayeni et al, 2019). Mild traumatic brain injuries (mTBIs) account for over 2 million emergency department visits per year in the US alone and are more prevalent in athletes/active youth (Langlois, Rutland‐Brown, & Wald, 2006), the military (Bigler & Tsao, 2017; Tanielian et al, 2008), and older adults (Centers for Disease Control, 2019).…”