Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: University of Alberta
Approved in 1 jurisdiction
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).
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.
13458Is 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.
36789What 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.
23458Do 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.
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.
My spinal cord injury is between my neck and mid-back.
I am between 18 and 65 years old.
Exclusion Criteria
I can sit or lie down for 2 hours without worsening any condition like low back pain.
My high blood pressure is not under control.
I currently have a urinary tract infection.
I often have sudden and severe high blood pressure.
I have lung problems like COPD or a recent lung infection.
I have significant memory or thinking problems.
I have active pressure sores.
I have heart or blood vessel disease.
I have severe swelling in my feet or legs.
I have signs of a blood clot in my leg.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Hyperoxia followed by room airExperimental Treatment1 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 hyperoxiaPlacebo Group1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Alberta, Clinical Sciences BldgEdmonton, Canada
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Who is running the clinical trial?
University of AlbertaLead Sponsor
Canadian Institutes of Health Research (CIHR)Collaborator
References
Hyperbaric oxygen (HBO) therapy for acute traumatic cervical spinal cord injury. [2019]A retrospective study of spinal cord injury (SCI) treated with and without hyperbaric oxygen (HBO) therapy.
Prediction of neurologic outcome in patients with spinal cord injury by using hyperbaric oxygen therapy. [2019]The effectiveness of hyperbaric oxygen therapy (HBO) in predicting neurological recovery in patients with spinal cord injury was evaluated. HBO has been used to treat spinal cord injury, but HBO does not appear to greatly alter the neurological outcome. This is the first report of the use of HBO as a diagnostic tool to evaluate neurological recovery after spinal cord injury. The study group consisted of 22 patients, aged 21-73 years, with spinal cord injuries. The effect of HBO was evaluated on admission and categorized as one of four grades (excellent, good, fair, or poor). The neurological status was evaluated on admission and at the time of follow-up, according to Frankel grade and the American Spinal Injury Association (ASIA) motor score. Correlations between the HBO effect and Frankel grade recovery and correlations between the HBO effect and recovery rate of the ASIA motor score were evaluated. The recovery in Frankel grade from admission to the final follow-up became better as the effectiveness of HBO increased (r = 0.445; P = 0.0414). The Frankel grade (r = 0.036; P = 0.871) and ASIA motor score (r = 0.029; P = 0.893) on admission did not correlate with the recovery in Frankel grade. There was a significant correlation between the HBO effect and the recovery rate of the ASIA motor score (r = 0.586; P = 0.0072), but this correlation was weaker than that for the ASIA motor score on admission (r = 0.752; P = 0.0006). We conclude that HBO can be employed to assess the status of spinal cord function recovery after spinal cord injury.
The role of multiple hyperbaric oxygenation in expanding therapeutic windows after acute spinal cord injury in rats. [2019]Hyperbaric oxygenation (HBO) therapy has been reported to improve neurological recovery after spinal cord injury (SCI). In the present study, the authors examined whether multiple HBO therapy can expand the therapeutic window after acute SCI.
Multiple hyperbaric oxygenation (HBO) expands the therapeutic window in acute spinal cord injury in rats. [2019]Hyperbaric oxygenation (HBO) therapy has been reported to improve neurological recovery following spinal cord injury (SCI). In the present study, we examined whether multiple HBO expands the therapeutic window for acute SCI. Single HBO (2.8 ATA, 1 hour) treatment was used at 30 minutes, 3 hours, and 6 hours following SCI, and serial HBO treatment (once daily for 1 week) at 6 hours and 24 hours post-injury. Mild SCI was induced by adjusting the height for a weight drop insult (10 g) to 6.25 mm above the exposed spinal cord. The group of animals receiving a single HBO intervention beginning at 30 minutes and 3 hours, or serial HBO treatment starting at 6 hours following the injury had a significantly better neurological recovery than animals with SCI only. The results of this study demonstrate that multiple HBO expands the therapeutic window for acute SCI to 6 hours after injury, further that serial HBO administration is superior to single HBO therapy.
Hyperbaric oxygen treatment in the experimental spinal cord injury model. [2018]Spinal cord trauma is a major cause of mortality and morbidity. Although no known treatment for spinal cord injury exists, a limited number of effective treatment modalities and procedures are available that improve secondary injury. Hyperbaric oxygen (HBO) treatment has been used to assist in neurologic recovery after cranial injury or ischemic stroke.
The effect of hyperbaric oxygen therapy on kidneys in a rat model. [2022]Hyperbaric oxygen therapy (HBOT) is used for treating various medical conditions. As far as known yet, HBOT is safe with few major side effects that are easy to avoid using a proper protocol. Renal tubular damage was observed in rats exposed to HBOT in a preliminary study conducted in our institution. Aim. We aim to assess whether HBOT causes renal damage and, if so, whether this is dose dependent.
A Retrospective Analysis of Adverse Events in Hyperbaric Oxygen Therapy (2012-2015): Lessons Learned From 1.5 Million Treatments. [2022]To describe the distribution and occurrence of adverse events recorded during hyperbaric oxygen (HBO) therapy from 2012 to 2015. In this analysis, events are defined as otic/sinus barotrauma, confinement anxiety, hypoglycemia, oxygen toxicity, pneumothorax, seizure, and shortness of breath.
Hyperbaric oxygen therapy for spinal cord injury: A protocol for systematic review and meta-analysis. [2023]Hyperbaric oxygen (HBO) therapy can prevent further spinal cord injury (SCI) caused by spinal cord ischemia-reperfusion injury to the maximum extent, which has been reported increasingly in recent years. However its security and effectiveness still lack of high-quality medical evidence. In this study, we will perform a systematic review of previously published randomized controlled trials (RCTs) to evaluate the efficacy and safety of HBO therapy for SCI.
Adverse effects of hyperbaric oxygen therapy: a systematic review and meta-analysis. [2023]Hyperbaric oxygen therapy (HBOT) is one of the common clinical treatments, but adverse effects have hampered and limited the clinical application and promotion of hyperbaric oxygen therapy. A systematic review and meta-analysis of the adverse effects of hyperbaric oxygen therapy have conducted by our group to provide a theoretical basis for clinical treatment.