A Double-blind Randomized Trial of Hyperbaric Oxygen Versus Sham for Persistent Symptoms After Brain Injury
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.
Condition:
Brain Injury, Chronic
Treatment:
Hyperbaric Oxygen
Start Date:
September 6, 2017
Sponsor:
Lindell Weaver
For More Information:
https://clinicaltrials.gov/show/NCT01986205