Hyperbaric Oxygen Therapy in Chronic Stable Brain Injury
Condition: Brain Injury; Sequelae; Stroke; Anoxia; Trauma
MeSH terms: Brain Injuries; Hypoxia; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to discover the feasibility of conducting clinical research in
      individuals with chronic sequelae following brain injury who are given hyperbaric oxygen.
      This study will also look at the outcome of individuals with a chronic stable brain injury
      due to trauma, anoxia (lack of oxygen to the brain), or stroke, who are given hyperbaric
      oxygen. Outcome measures testing cognitive (memory, etc.) and functional (balance, strength,
      etc.) measures will be performed before the hyperbaric sessions, immediately following them,
      and 6 months later. The subject will receive 60 hyperbaric sessions, 60 minutes in the
      chamber, to a pressure of 1.5 ATA, once daily, Monday through Friday.
    

Detailed description: 
      Hyperbaric oxygen is presently being used in an attempt to improve functional outcome
      following a multitude of brain injuries such as stroke, anoxic brain injury, traumatic brain
      injury, and others. Family members of brain-injured individuals correspond via the Internet
      into coalitions demanding that their loved ones receive hyperbaric oxygen therapy. There are
      anecdotal reports of benefit with hyperbaric oxygen following brain injury but there is
      little credible scientific evidence for efficacy of hyperbaric oxygen in brain injury.
      Clearly, what is needed to answer if hyperbaric oxygen improves brain injury are results from
      carefully designed multi-center, prospective, randomized controlled clinical trials. However,
      the implementation of such a Phase III clinical trial is challenging without information from
      Phase II trials. We propose to conduct a feasibility trial that may potentially guide a
      future Phase III clinical trial.

      Mechanisms by which hyperbaric oxygen improves sequelae following brain injury are
      speculative. Hyperbaric oxygen upregulates growth factor receptor sites on human endothelium
      and can stimulate healing in hypoxic wounds. It is conceivable that hyperbaric oxygen exerts
      similar effects within damaged neuronal tissue but this information is lacking. Stem cells
      are present in the adult brain and there is speculation that hyperbaric oxygen may stimulate
      these stem cells to generate new neurons, but once again, this information is speculative.

      In this Phase II feasibility prospective clinical trial, we propose to recruit and enroll 70
      brain-injured subjects and expose them daily to hyperbaric oxygen at 1.5 atmospheres absolute
      for 60 minutes per session, for 60 sessions per subject. This research protocol is the one
      most commonly used by practitioners who claim benefit with hyperbaric oxygen therapy. Before
      and after the 60 hyperbaric oxygen sessions, and at 6 months following completion of
      hyperbaric oxygen, outcome measures consisting of neuropsychological testing, functional
      measures, health-related quality of life measures, and a neurological examination will be
      conducted and analyzed with the subjects serving as their own controls. Important information
      regarding a subsequent Phase III clinical trial, including subject recruitment, tolerance and
      risk of therapy, dropout rate, and potential benefit or lack of benefit with hyperbaric
      oxygen will be reported.
    

Intervention name(s): Hyperbaric oxygen therapy (HBO2)
Intervention type(s): Procedure
Intervention description(s): 60 daily hyperbaric oxygen sessions 1.5 atmospheres absolute, 100% oxygen 60 minutes per session, from door closing to door opening
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brain injury with sequelae from stroke, anoxia, or trauma