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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether breathing pure oxygen, known as Hyperbaric Oxygen Therapy (HBOT), can improve movement and sensation in individuals with severe spinal cord injuries. Participants will breathe either room air or pure oxygen through a mask during different study phases. The researchers aim to determine if pure oxygen affects the body's response to touch and reflexes. This study may suit individuals with a spinal cord injury that occurred at least three months ago and impacts daily life, such as causing movement or sensation difficulties. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to explore this innovative therapy.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that breathing pure oxygen can be safe for people with spinal cord injuries. Studies on a similar treatment, hyperbaric oxygen therapy, suggest it is often well-tolerated and promising. This therapy might help prevent further damage to the spinal cord.

While generally considered safe, this treatment is not approved for every condition. It is used in specific situations, such as certain injuries and wounds. Most participants in past studies did not experience major problems with the treatment. However, like any treatment, side effects may occur.

Prospective study participants might find it helpful to consult doctors or researchers for more details about what to expect. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the use of pure oxygen, or hyperoxia, for spinal cord injury because it offers a novel approach compared to traditional treatments like surgery, medications, and physical therapy. Hyperoxia involves breathing nearly 100% oxygen, which may enhance oxygen delivery to damaged spinal tissues, potentially speeding up recovery and improving nerve function. This unique delivery method through a face mask allows targeted, temporary exposure, which could lead to faster results than current therapies. By possibly enhancing nerve repair and function, hyperoxia represents a promising new direction in spinal cord injury treatment.

What evidence suggests that pure oxygen might be an effective treatment for spinal cord injury?

Research has shown that breathing pure oxygen, known as hyperoxia, might aid recovery in people with spinal cord injuries. Studies have found that hyperbaric oxygen therapy, which involves breathing oxygen in a pressurized room, can prevent further spinal cord damage by reducing harm from poor blood flow. A review of several studies found this therapy to be a safe and promising method for improving movement and sensation after a spinal cord injury. In some animal studies, higher oxygen levels improved blood flow in the spinal cord, potentially aiding recovery. While more research is needed, these findings suggest that high oxygen levels could support healing in spinal cord injuries. In this trial, participants will undergo different phases, receiving either high oxygen levels or room air, allowing researchers to assess hyperoxia's effects on spinal cord injury recovery. ^{1 2 6 7 8}

Who Is on the Research Team?

Jaynie Yang, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7717804/

Hyperbaric oxygen therapy for spinal cord injury Hyperbaric oxygen (HBO) therapy can prevent further spinal cord injury (SCI) caused by spinal cord ischemia-reperfusion injury to the maximum extent.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1008127523000445

Advance in hyperbaric oxygen therapy in spinal cord injury A meta-analysis concluded that hyperbaric oxygen therapy might be helpful for clinical treatment as a safe, promising and effective choice to limit secondary ...

3. withpower.com withpower.com/trial/early-phase-1-hyperoxia-6-2022-51511

Hyperoxia for Spinal Cord Injury This systematic review aims to evaluate the efficacy and safety of hyperbaric oxygen (HBO) therapy for spinal cord injury (SCI) by analyzing previously ...

4. ovid.com ovid.com/journals/jpin/fulltext/10.4103/ejpi.ejpi-d-23-00003~acute-hyperoxia-improves-spinal-cord-oxygenation-and

Acute Hyperoxia Improves Spinal Cord Oxygenation... The results showed that contused animals had significantly lower spinal cord oxygenation levels than uninjured animals during normoxia. Peripheral oxyhemoglobin ...

5. journals.sagepub.com journals.sagepub.com/doi/10.3233/BMR-200157

Effects of hyperbaric oxygen therapy on patients with spinal ... HBO therapy may improve motor function, sensory function and psychology after SCI compared to conventional treatments.

6. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/hyperbaric-oxygen-therapy

Hyperbaric Oxygen Therapy Be aware that HBOT is not considered safe and effective for treating certain conditions. These include HIV/AIDs, brain injury, heart disease, stroke, asthma, ...

7. aetna.com aetna.com/cpb/medical/data/100_199/0172.html

Hyperbaric Oxygen Therapy (HBOT) The investigators found HBOT significantly improved chance of healing for radiation proctitis (relative risk 2.7, 95% confidence interval [CI]: 1.2 to 6.0). The ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8465921/

A General Overview on the Hyperbaric Oxygen Therapy Hyperbaric Oxygenation Alleviates Chronic Constriction Injury (CCI)-Induced Neuropathic Pain and Inhibits GABAergic Neuron Apoptosis in the Spinal Cord.