Hyperbaric Oxygen for Traumatic and Non-traumatic Brain Injury — HYBOBI2  

Brain Injury, Chronic Clinical Trial

Official title: A Double-blind Randomized Trial of Hyperbaric Oxygen Versus Sham for Persistent Symptoms After Brain Injury

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury, Chronic
• Wounds and Injuries

• NCT number: NCT01986205
• Study type: Interventional
• Source: Intermountain Health Care, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: September 6, 2017
• Completion date: May 31, 2022