Hyperbaric Oxygen Effects on Persistent Post-concussive Symptoms
United States20 participantsStarted 2022-06-28
Plain-language summary
Persistent post-concussive symptoms (PPCS) are a source of significant burden among a subset of patients with concussion with prevalence rates previously reported between 11 - 82% based on timing of assessment, diagnostic criteria, or population under study.
Examples of persistent post-concussion symptoms include balance problems, headaches, fatigue, poor concentration, forgetfulness, anxiety, irritability, and sleep disturbance. Few proposed therapies have proved successful in the management of persistent post-concussion symptoms following mild traumatic brain injury.
The investigators will explore hyperbaric oxygen administered in a randomized sham-controlled clinical trial as an effective and tolerable treatment in improving neuropsychological status among adult patients with persistent post-concussive symptoms.
The overall hypothesis to be evaluated is that hyperbaric oxygen improves neuropsychological status and a serum concussion biomarker associated with PPCS.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Volunteers must have a history of mild traumatic brain injury, specifically, persistent post-concussive symptoms after examination by a neuropsychologist or neurologist.
* Volunteers time from concussive incident (Mild traumatic brain injury) must be between 3 months - 5 years following head trauma incident
* TBI was caused by non-penetrating trauma
* Volunteers must have current complaints of TBI symptoms such as headache, dizziness, or cognitive or affective problems
* Volunteers must be 18-year-old or more
* Willing and able to provide informed consent
* Able to speak and read English, as primary language
* Agrees to provide blood samples for clinical lab tests
* Willing and committed to comply with research protocol and complete all outcome measures
* Able to equalize middle ear pressures or willing to undergo needle myringotomies if needed
* Willingness and committed to comply with study protocol outlined reproductive plan based on baseline reproductive status
Exclusion Criteria:
* Prior treatment with hyperbaric oxygen treatment
* Hyperbaric chamber inside attendant, professional, SCUBA diver (technical, commercial, operational/military or recreational)
* The investigators will exclude pregnant women from this study because potential fetal adverse reactions triggered by high oxygen partial pressures such as retrolenticular fibroplasia though careful review of human data are generally reassuring such as the use of hyperbaric oxygen to treat acute…
What they're measuring
1
Changes in Repeatable battery for the assessment of neuropsychological status (RBANS)