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

10 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Hyperbaric Oxygen Therapy for Concussion?

Some studies suggest that Hyperbaric Oxygen Therapy (breathing pure oxygen in a pressurized room) may help improve brain function after traumatic brain injuries by enhancing the brain's ability to use oxygen. However, results are mixed, and more research is needed to confirm its effectiveness for concussions specifically. ^{1 2 3 4 5}

Is hyperbaric oxygen therapy generally safe for humans?

Hyperbaric oxygen therapy is generally considered safe, with rare occurrences of minor issues like ear or sinus discomfort and headaches. Seizures are a rare but possible side effect, especially in people with neurological conditions, but no serious adverse events have been reported in recent studies. ^{6 7 8 9 10}

How does hyperbaric oxygen therapy differ from other treatments for concussion?

Hyperbaric oxygen therapy (HBOT) is unique because it involves breathing pure oxygen in a pressurized room, which can enhance the brain's ability to use oxygen more effectively after treatment. Unlike standard treatments for concussion, which are limited, HBOT has shown significant improvements in symptoms like memory, cognitive function, and quality of life in people with post-concussion syndrome. ^{4 5 11 12 13}

What is the purpose of this trial?

The use of Hyberbaric Oxygen Therapy (HBOT) would be a new treatment plan rather than conventional rest. If effective, this new use technology would add to the clinical treatment among mild traumatic brain injury (mTBI) patients. The use of a point of care Glial Fibrillary Acidic Protein (GFAP) biomarker would aid in clinical decision making to create a new care plan of return to sport among unarmed combat athletes who suffer from mTBI. The innovation would be a new treatment and diagnosis strategy that will protect these athletes from serious long-term sequelae. There are no published randomized controlled studies using HBOT to treat concussed athletes within one week of injury. There are no published studies using GFAP levels to predict post concussive symptoms (PCS).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Regional CBF in chronic stable TBI treated with hyperbaric oxygen. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Improving neuropsychological function after chronic brain injury with hyperbaric oxygen. [2006]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Biochemical response to hyperbaric oxygen treatment of a transhemispheric penetrating cerebral gunshot injury. [2020]

4. United States 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. [2015]

5. Australia pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for chronic post-concussive syndrome. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A Retrospective Analysis of Adverse Events in Hyperbaric Oxygen Therapy (2012-2015): Lessons Learned From 1.5 Million Treatments. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse events and blinding in two randomized trials of hyperbaric oxygen for persistent post-concussive symptoms. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Seizure during hyperbaric oxygen therapy: experience at a single academic hospital in Korea. [2021]

9. Greece pubmed.ncbi.nlm.nih.gov

Effect of hyperbaric oxygenation therapy on post-concussion syndrome. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Seizures during hyperbaric oxygen therapy: retrospective analysis of 62,614 treatment sessions. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen: B-level evidence in mild traumatic brain injury clinical trials. [2017]

12. United States pubmed.ncbi.nlm.nih.gov

Case report: Treatment of mild traumatic brain injury with hyperbaric oxygen. [2010]

13. Australia pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for mild traumatic brain injury persistent postconcussion syndrome: a randomized controlled trial. [2023]