Post-Concussion Syndrome Clinical Trial
Official title:
Hyperbaric Oxygen for Post Concussive Syndrome
We would like to see if Hyperbaric Oxygen can help improve the symptoms that result from Post Concussive Syndrome.
Purpose:
The purpose of this study is to examine the role of Hyperbaric Oxygen Therapy (HBOT) in
decreasing symptoms in patients with a diagnosis of chronic post concussive syndrome (PCS).
Hypothesis:
The study hypothesis is that HBOT will decrease symptoms measured by standard measurement
tools when provided to patients who have a diagnosis of PCS and are 6 months to 36 months
post injury.
Study Overview:
Hyperbaric oxygen therapy (HBOT) involves the administration of inhaled 100% oxygen at
increased ambient pressure inside a closed vessel. HBOT produces greatly elevated arterial
and tissue oxygen tensions, producing a wide variety of physiological effects at the cellular
and sub cellular level.
Participants will be selected from the post-concussive syndrome population based on an
expectation that they would experience a clinically significant improvement. Eligible
subjects will be experiencing post concussive symptoms related to an injury within the last 6
to 36 months. The study will be enrolling 150 participants and will be randomized to two
different treatment arms: experimental group and a waitlist group.
Each participant will receive a series of forty 2 hour treatments, delivered once a day, 5
days a week, within the hyperbaric oxygen chamber.There will be assessments completed before
treatment series begins, at the end of treatment, 8 months and 14 months after treatment
begins. The primary outcome will be administered at these times as well as every two weeks
once treatment begins until the end of the study.
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