Hyperbaric Oxygen for Traumatic and Non-traumatic Brain Injury
Condition: Brain Injury, Chronic
MeSH terms: Brain Injuries; Brain Injury, Chronic; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on
      long-term symptoms after brain injury. This study will enroll 90 individuals with persistent
      problems 6 months to 10 years after a brain injury. These individuals will be randomized to
      receive either oxygen or air in a pressurized hyperbaric chamber. Participants will receive
      40 daily hyperbaric chamber sessions.

      Participants will have a series of tests and questionnaires before they begin their chamber
      sessions, after they complete 40 sessions, and 6 months after they joined the study. These
      tests include computer-based and pencil-and-paper questionnaires and thinking tests, brain
      imaging, a neurological examination, and an eye exam. Participants will also be asked to
      provide blood for future research.

      After the 6-month tests are complete, all participants will receive 40 hyperbaric oxygen
      sessions, then undergo the same tests at 9 months and 12 months.
    

Detailed description: 
      This is a single center, randomized, double-blind study with a subsequent open-label
      intervention period to explore whether a course of hyperbaric oxygen can ameliorate
      persistent symptoms after brain injury. In this study, adult men and women with persistent
      symptoms 6 months to 10 years after injury will be randomized to receive 40 hyperbaric oxygen
      sessions (100% oxygen at 1.5 atmospheres absolute, 60 minutes door-to-door) or sham chamber
      sessions (room air chamber excursion at near-ambient pressure, 60 minutes door-to-door).
      Chamber sessions will be provided Monday through Friday, excluding holidays, and participants
      will have up to 12 weeks to complete their 40 sessions.

      Participants will be evaluated before the chamber sessions, at 13 weeks, and at 6 months.
      Assessments include self-administered questionnaires, neuropsychological function, a brief
      neurological examination, electroencephalography, visual function tests, and a
      neuro-optometry evaluation. These outcome tools will measure symptoms and deficit at the time
      of enrollment and subsequent evaluations, and provide insight into whether hyperbaric oxygen
      can play a role in recovery from brain injury.

      Once the participants have completed their 6 month evaluations, they will enter an open
      intervention group, receiving 40 hyperbaric sessions at 1.5 atmospheres absolute for 60
      minutes. Participants will have up to 12 weeks to complete these sessions. Participants will
      be evaluated after the second set of chamber sessions (at 9 months and again at 12 months).
      Individuals will then be assessed annually until study closure (12-month follow-up of the
      last enrolled participant).

      Participants will be asked to provide blood for long-term storage of serum, plasma, and DNA
      for future investigations, including apolipoprotein E genotype.
    

Intervention name(s): Hyperbaric Oxygen; Minimal pressure air
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Hyperbaric oxygen (USP oxygen >99%) delivered in a hyperbaric chamber pressurized to 1.5 atmospheres absolute.; Room air delivered in a hyperbaric chamber with minimal pressurization.
Other intervention name(s): HBO2; HBOT; HBO; Hyperbaric oxygen therapy; Room air
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Concussion; Traumatic brain injury; Hyperbaric oxygenation; Post-concussion symptoms; Headache; Carbon monoxide