Can pressurized oxygen ease persistent concussion woes?
NCT ID NCT05173818
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether breathing pure oxygen in a pressurized chamber (hyperbaric oxygen therapy) can help adults with persistent post-concussion symptoms like headaches, fatigue, and memory problems. Twenty participants with mild traumatic brain injury received either real treatment or a sham procedure over 40 sessions. The goal was to see if the therapy improves thinking skills and reduces a brain-damage marker in the blood.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hyperbaric oxygen therapy
- What this could lead to
- If it works, this could offer a new treatment option for people with long-lasting concussion symptoms that haven't improved with other therapies.
- What could go wrong
- This is a small, early-phase study with only 20 participants, so results may not apply to everyone. The sham control also involves some pressure, which could reduce the apparent benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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20 people
The number who actually took part.
- Started
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Jun 2022
- Finished
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Aug 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 carbon monoxide poison in the pregnant patient.13 * Prisoners * Minors * Unable to protect airway or requires frequent suctioning * Known or suspected peri-lymphatic fistula * Presence of tracheostomy (due to limitations in auto-inflating the middle ear) * Unable to participate fully in outcome assessments * Unable to cooperate with hyperbaric oxygen treatments * Unable to speak and read English, as primary language * Not cooperating with instructions during hyperbaric oxygen treatments such as bringing contraband items into the chamber (such as fire lighter) * Not competent to sign their own consent. Such potential participants will not have the capacity to participate in a full range of neurocognitive testing * Pre-existing diagnosis of a psychotic disorder(s): schizophrenia, bipolar, dissociative disorder * History of moderate or severe traumatic brain injury * History of brain injury not of traumatic etiology such as stroke or drug-induced coma * Verifiable diagnosis of learning disability. Other pre-existing cognitive issues may make it difficult for potential participants to fill out certain outcome assessments such as neurobehavioral symptomatic inventory. This could lead to measurement bias or confound the result. * Claustrophobia and unwilling to enter hyperbaric chamber * Untreated pneumothorax * Presence of implanted device with un-verifiable test to pressure by manufacturer * Concurrent enrollment in an alternate interventional trial for post concussive symptoms
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Essentia Health
Fargo, North Dakota, 58103, United States
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Other studies related to the condition(s) this trial covers.
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