Hyperbaric Oxygen Therapy for Concussion

Overseen By Michael Harl, MD MBA FACS

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Michael Harl

Disqualifiers: Female, Prisoner, Severe GCS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Hyperbaric Oxygen Therapy (HBOT) can effectively treat concussions in male unarmed combat athletes. Typically, rest serves as the standard treatment, but the trial aims to determine if HBOT can accelerate recovery and safely return athletes to their sport. The trial will compare two groups: one receiving HBOT and the other following conventional rest. Ideal participants are male athletes who have experienced a head injury resulting in a suspension from competition. As an unphased trial, this study provides athletes the opportunity to explore a potentially faster recovery method.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Hyperbaric Oxygen Therapy is safe for treating concussions?

Research has shown that Hyperbaric Oxygen Therapy (HBOT) is generally safe for treating traumatic brain injuries. Studies have found that HBOT can help with thinking and memory problems in people who continue to have symptoms after a concussion. It appears to aid brain healing from the injury.

HBOT is widely available and considered relatively safe. While some risks or side effects exist, they are uncommon. For instance, some individuals might experience ear discomfort due to pressure changes, similar to what occurs when flying in an airplane. Larger studies are still needed to fully confirm its benefits, but many people tolerate the treatment well.

In summary, while researchers continue to explore new uses for HBOT, its safety record suggests it is a promising option for those with concussion-related issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Hyperbaric Oxygen Therapy (HBOT) for concussions because it offers a unique approach compared to traditional treatments like rest and medication. Unlike typical methods that focus on symptom management, HBOT involves breathing pure oxygen in a pressurized chamber, which may accelerate healing by increasing oxygen supply to the brain. This enhanced oxygen delivery could potentially reduce inflammation and promote faster recovery of brain tissue. If successful, HBOT might offer a quicker, more effective recovery path for concussion patients.

What evidence suggests that Hyperbaric Oxygen Therapy might be an effective treatment for concussion?

Research has shown that Hyperbaric Oxygen Therapy (HBOT), which participants in this trial may receive, can help treat symptoms of mild traumatic brain injury (mTBI). Studies have found that patients who received HBOT experienced better brain function compared to those who did not. In one study, the HBOT group improved in 11 out of 14 areas of recovery. This suggests that HBOT may alleviate symptoms that persist after a concussion. While more research is needed, these findings offer hope for those dealing with post-concussion issues. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for unarmed combat athletes who have recently experienced a mild traumatic brain injury (mTBI), such as a concussion, and are dealing with symptoms like headaches. They should not have had any serious injuries at home or other types of brain injuries.

Inclusion Criteria

I have a head injury with a specific suspension time due to the injury's severity.

Exclusion Criteria

I will be randomly assigned to receive either hyperbaric oxygen therapy or standard rest care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Hyberbaric Oxygen Therapy (HBOT) as a new treatment plan for mild traumatic brain injury

13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the use of GFAP biomarker for clinical decision making

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyberbaric Oxygen Therapy

Trial Overview

The study is testing Hyperbaric Oxygen Therapy (HBOT) as an alternative to the usual rest treatment for mTBI. It also examines using Glial Fibrillary Acidic Protein (GFAP) levels to decide when athletes can return to sport safely.

How Is the Trial Designed?

Group I: HBOT Treatment Group Experimental Treatment 1 Intervention

Group II: Conventional Rest Control Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

Michael Harl

Lead Sponsor

Trials

1

Recruited

10+

Published Research Related to This Trial

In a review of over 1.5 million hyperbaric oxygen therapy treatments, only 0.68% were linked to adverse events, indicating that serious complications are rare.

The most common issues reported were barotrauma and confinement anxiety, while severe events like oxygen toxicity occurred in less than 0.05 per 1000 treatments, suggesting that HBO therapy is a safe and low-risk treatment when following proper protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Retrospective Analysis of Adverse Events in Hyperbaric Oxygen Therapy (2012-2015): Lessons Learned From 1.5 Million Treatments. Jokinen-Gordon, H., Barry, RC., Watson, B., et al.[2022]

Hyperbaric oxygen therapy (HBOT) has been shown to be an effective treatment for mild to moderate traumatic brain injury and persistent postconcussion syndrome, supported by B-level evidence from peer-reviewed clinical trials.

Current practices using pressurized air as a control in clinical trials may not be valid, as they can produce therapeutic effects similar to HBOT, thus potentially biasing the results of studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen: B-level evidence in mild traumatic brain injury clinical trials. Figueroa, XA., Wright, JK.[2017]

In a study involving 42 patients with severe traumatic brain injury, the combination of hyperbaric oxygen (HBO2) and normobaric hyperoxia (NBH) significantly increased brain tissue oxygen levels and improved markers of cerebral metabolism compared to standard care.

The combined HBO2/NBH treatment resulted in a 26% reduction in mortality and a 36% improvement in favorable outcomes, indicating its potential as an effective therapeutic strategy for severe TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, randomized Phase II clinical trial to evaluate the effect of combined hyperbaric and normobaric hyperoxia on cerebral metabolism, intracranial pressure, oxygen toxicity, and clinical outcome in severe traumatic brain injury. Rockswold, SB., Rockswold, GL., Zaun, DA., et al.[2015]

A systematic review of 4 randomized controlled trials involving hyperbaric oxygenation (HBO) therapy found no significant improvement in post-concussion syndrome (PCS) symptoms compared to a sham treatment, indicating that HBO therapy may not be effective for this condition.

The analysis showed no meaningful differences in symptom scores on established questionnaires, suggesting that further large-scale clinical trials are needed to properly assess the efficacy of HBO therapy for PCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of hyperbaric oxygenation therapy on post-concussion syndrome. Dong, Y., Hu, X., Wu, T., et al.[2020]

Hyperbaric oxygen (HBO) therapy may help improve biochemical parameters in patients with traumatic brain injuries, as demonstrated in a case report of a 23-year-old man with a severe gunshot wound.

The study suggests that HBO therapy could be a beneficial treatment option to reduce secondary complications following traumatic brain injury, although further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biochemical response to hyperbaric oxygen treatment of a transhemispheric penetrating cerebral gunshot injury. Thelin, EP., Bellander, BM., Nekludov, M.[2020]

In a study of 1,308 patients receiving hyperbaric oxygen (HBO2) therapy, five seizure episodes were reported during 10,425 treatments, indicating a low but notable risk of seizures, particularly in patients with carbon monoxide poisoning and arterial gas embolism.

Despite the occurrence of seizures, none of the patients experienced lasting effects, suggesting that while seizures can happen during HBO2 therapy, the overall safety profile remains high, and clinicians should be prepared to manage such events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizure during hyperbaric oxygen therapy: experience at a single academic hospital in Korea. Lee, CH., Choi, JG., Lee, JS., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11807354/

Evaluating the Impact of Hyperbaric Oxygen Therapy and ...

Harch conducted a systematic review and dosage analysis with HBOT efficacy in mild traumatic brain injury persistent post-concussion syndrome.

2.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.815056/full

Hyperbaric Oxygen Therapy Efficacy in Mild Traumatic ...

Overall, the HBOT group achieved significant improvement in 11/14 outcome instruments compared to 13/14 after HBOT in the crossed-over Control Group. Twelve of ...

3.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000211724

Hyperbaric Oxygen Therapy (HBOT) for Treating ...

Conclusions: HBOT significantly improves neurocognitive deficits in traumatic brain injury patients compared to baseline. However, larger trials ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2451865423001229

Hyperbaric Oxygen Therapy versus placebo for post- ...

The HOT-POCS study will compare the efficacy of a standardized HBOT treatment protocol against a true placebo gas for the treatment of PCS within 12 months ...

5.

nature.com

nature.com/articles/s41598-025-86631-6

A double-blind randomized trial of hyperbaric oxygen for ...

Data at the prime outcome interval was analyzed on 42 participants (16 mild TBI, 4 severe TBI, 4 CO in HBO2; 11 mild TBI, 4 moderate TBI, 1 ...

6.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1641033/full

Hyperbaric oxygen therapy improves post-concussion ...

This study provides initial evidence that HBOT can elicit significant cognitive improvements in adults with chronic PCS from childhood TBI.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01306968

Hyperbaric Oxygen Therapy (HBO2) for Persistent Post- ...

If HBO2, which is regularly available and relatively safe, improves outcome in brain-injured subjects by treating the underlying pathophysiology of post- ...