Hyperoxia for Spinal Cord Injury

Overseen By Michelle Barnes, PT

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Alberta

Disqualifiers: Cardiovascular disease, Cancer, Pregnancy, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This proof-of-principle study will determine if breathing an increased concentration of oxygen above the concentration in normal room air results in changes in the sensory and motor function in people with subacute or chronic, severe spinal cord injury (SCI).

Do I need to stop my current medications for the trial?

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 spinal cord injury?

Research suggests that Hyperbaric Oxygen Therapy (HBO) may help improve neurological recovery after spinal cord injury by expanding the time window for effective treatment. Studies in animals have shown that multiple HBO sessions can lead to better recovery compared to a single session, and some human studies indicate a correlation between HBO treatment and improved motor function recovery. ^{1 2 3 4 5}

Is hyperbaric oxygen therapy generally safe for humans?

Hyperbaric oxygen therapy (HBOT) is generally considered safe, but it can have side effects like ear or sinus pain, anxiety from being in a confined space, low blood sugar, oxygen toxicity, lung collapse, seizures, and shortness of breath. These side effects are usually manageable with proper protocols. ^{1 3 6 7 8}

How is hyperbaric oxygen therapy different from other treatments for spinal cord injury?

Hyperbaric oxygen therapy (HBO) is unique because it involves breathing pure oxygen in a pressurized chamber, which can help improve neurological recovery after spinal cord injury by expanding the therapeutic window, allowing treatment to be effective even hours after the injury. Unlike other treatments, HBO specifically targets the prevention of further damage from spinal cord ischemia-reperfusion injury, although its safety and effectiveness still require more high-quality evidence. ^{1 2 3 4 9}

Research Team

Jaynie Yang, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for adults aged 18-65 with severe spinal cord injuries between C5 and T10, which occurred at least 3 months ago. Participants must have an ASIA Impairment Scale rating of A, B, or C at discharge and be able to consent. It's not suitable for those with conditions worsened by remaining still for long periods, UTIs, cognitive impairments, cancer, pressure sores, uncontrolled autonomic dysreflexia or blood pressure issues.

Inclusion Criteria

My spinal cord injury severity is classified as A, B, or C.

Able to give informed, written consent

My spinal cord injury is between my neck and mid-back.

Exclusion Criteria

I can sit or lie down for 2 hours without worsening any condition like low back pain.

I have lung problems like COPD or a recent lung infection.

My high blood pressure is not under control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Experimental Sessions

Participants attend 4 experimental sessions to test sensory and reflex functions with room air and 99% oxygen

7 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after experimental sessions

2 weeks

Treatment Details

Interventions

• Pure oxygen

Trial Overview The study tests if breathing pure oxygen (99%) can improve sensory and motor functions in individuals with chronic severe spinal cord injury. The oxygen used is from Praxair (DIN# 02014408), and the goal is to see if hyperoxia leads to functional changes compared to normal air concentration.

Participant Groups

Group I: Hyperoxia followed by room air Experimental Treatment 1 Intervention

Group 1 will receive oxygen (99%) in Phase 1, and room air (placebo) in Phase 2. Each phase will consist of 2 experiments. In Phase 1, the first experiment will test skin sensation using von Frey Hairs, while the second experiment will test a cutaneous reflex. In Phase 2, the first experiment will test the cutaneous reflex, while the second experiment will test skin sensation with von Frey Hairs. Both high oxygen and room air will be delivered through a face mask. The flow rate will be 10 litres/min for a 2-min period. Participants and experimenters will be blinded to the intervention. Measures will be taken before and after each exposure. In this way, each participant will be involved in four experimental sessions with a minimum of 2-week intervals between every testing session. Each experimental session will take approximately 1.5 to 2 hours. A total duration of involvement in the study is a minimum of 7 weeks.

Group II: Room air followed by hyperoxia Placebo Group 1 Intervention

Group 2 will receive room air (placebo) in Phase 1, and oxygen (99%) in Phase 2. Each phase will consist of 2 experiments. In Phase 1, the first experiment will test the cutaneous reflex, while the second experiment will test skin sensation with von Frey Hairs. In Phase 2, the first experiment will test skin sensation using von Frey Hairs, while the second experiment will test a cutaneous reflex. Both high oxygen and room air will be delivered through a face mask approved by Health Canada. The flow rate will be 10 litres/min for a 2-min period. Participants and experimenters will be blinded to the intervention. Measures will be taken before and after each exposure.In this way, each participant will be involved in four experimental sessions with a minimum of 2-week intervals between every testing session. Each experimental session will take approximately 1.5 to 2 hours. A total duration of involvement in the study is a minimum of 7 weeks.

Pure oxygen is already approved in United States for the following indications:

Approved in United States as Hyperbaric Oxygen Therapy for:

• Carbon monoxide poisoning
• Cyanide poisoning
• Crush injuries
• Gas gangrene
• Decompression sickness
• Acute or traumatic reduced blood flow in the arteries
• Compromised skin grafts and flaps
• Infection in a bone (osteomyelitis)
• Delayed radiation injury
• Flesh-eating disease (necrotizing soft tissue infection)
• Air or gas bubble trapped in a blood vessel (air or gas embolism)
• Chronic infection called actinomycosis
• Diabetic wounds that are not healing correctly

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

This systematic review aims to evaluate the efficacy and safety of hyperbaric oxygen (HBO) therapy for spinal cord injury (SCI) by analyzing previously published randomized controlled trials (RCTs), ensuring a comprehensive assessment of existing evidence.

The study will utilize rigorous methods, including the Cochrane risk of bias tool and data pooling with RevMan software, to provide high-quality medical evidence regarding HBO therapy's effectiveness in preventing further spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for spinal cord injury: A protocol for systematic review and meta-analysis. Li, T., Wang, Y., Feng, C., et al.[2023]

Hyperbaric oxygen (HBO) treatment significantly improved motor strength and reduced nitrite levels in rats with traumatic spinal cord injury, indicating its potential to aid recovery after such injuries.

Starting HBO treatment within the first hour after injury led to the best outcomes, suggesting that early intervention is crucial for maximizing recovery benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen treatment in the experimental spinal cord injury model. Yaman, O., Yaman, B., Aydın, F., et al.[2018]

In a study involving 70 rats with spinal cord injuries, multiple hyperbaric oxygen (HBO) treatments starting at 6 hours post-injury significantly improved neurological recovery compared to untreated controls.

Single HBO treatments initiated at 30 minutes and 3 hours after injury also enhanced recovery, indicating that HBO therapy can be effective within a 6-hour therapeutic window after acute spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of multiple hyperbaric oxygenation in expanding therapeutic windows after acute spinal cord injury in rats. Huang, L., Mehta, MP., Nanda, A., et al.[2019]

Multiple sessions of hyperbaric oxygenation (HBO) therapy can significantly improve neurological recovery in animals with acute spinal cord injury (SCI), expanding the effective treatment window to 6 hours post-injury.

Serial HBO treatment (once daily for a week) is more effective than a single HBO session, particularly when initiated at 6 hours after the injury, indicating a potential strategy for enhancing recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple hyperbaric oxygenation (HBO) expands the therapeutic window in acute spinal cord injury in rats. Huang, L., Mehta, MP., Eichhorn, JH., et al.[2019]

Hyperbaric oxygen therapy (HBO) does not significantly change neurological outcomes in spinal cord injury patients, but it can be used as a diagnostic tool to evaluate recovery.

In a study of 22 patients, a stronger HBO effect correlated with better recovery in the ASIA motor score, suggesting that while HBO may not improve outcomes, it can help assess the extent of recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction of neurologic outcome in patients with spinal cord injury by using hyperbaric oxygen therapy. Ishihara, H., Kanamori, M., Kawaguchi, Y., et al.[2019]

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) is associated with a higher incidence of adverse effects (30.11%) compared to control groups (10.43%), particularly when the treatment involves more than 10 sessions or chamber pressures exceed 2.0 ATA.

The most common side effect reported was ear discomfort, indicating that while HBOT can be beneficial, careful monitoring for adverse reactions is necessary, especially under specific conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of hyperbaric oxygen therapy: a systematic review and meta-analysis. Zhang, Y., Zhou, Y., Jia, Y., et al.[2023]

In a study involving 31 rats, hyperbaric oxygen therapy (HBOT) at 2 ATA for up to 10 days did not result in significant renal damage or impairment, suggesting that HBOT is safe for renal function in healthy subjects.

The research indicates that HBOT does not adversely affect renal function, as there were no significant changes in renal function tests or histopathological evaluations, supporting its safety profile in healthy rats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of hyperbaric oxygen therapy on kidneys in a rat model. Berkovitch, M., Tsadik, R., Kozer, E., et al.[2022]

In a retrospective study of 34 spinal cord injury cases, those treated with hyperbaric oxygen (HBO) therapy showed a mean improvement rate of 75.2%, indicating its potential effectiveness in acute traumatic cervical spinal cord injuries.

In comparison, the non-HBO group had a lower mean improvement rate of 65.1%, suggesting that HBO therapy may enhance recovery outcomes for patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen (HBO) therapy for acute traumatic cervical spinal cord injury. Asamoto, S., Sugiyama, H., Doi, H., et al.[2019]

References

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

Hyperbaric oxygen therapy for spinal cord injury: A protocol for systematic review and meta-analysis. [2023]

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

Hyperbaric oxygen treatment in the experimental spinal cord injury model. [2018]

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

The role of multiple hyperbaric oxygenation in expanding therapeutic windows after acute spinal cord injury in rats. [2019]

4. Austria pubmed.ncbi.nlm.nih.gov

Multiple hyperbaric oxygenation (HBO) expands the therapeutic window in acute spinal cord injury in rats. [2019]

5. Japan pubmed.ncbi.nlm.nih.gov

Prediction of neurologic outcome in patients with spinal cord injury by using hyperbaric oxygen therapy. [2019]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse effects of hyperbaric oxygen therapy: a systematic review and meta-analysis. [2023]

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

The effect of hyperbaric oxygen therapy on kidneys in a rat model. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen (HBO) therapy for acute traumatic cervical spinal cord injury. [2019]