An Early Phase 1 interventional study of Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408 in Spinal Cord Injuries, sponsored by University of Alberta. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by University of Alberta · Early Phase 1, Interventional, and Other
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).
This proof-of-principle study will include a small number of participants with subacute or chronic (>3 months post-injury), severe spinal cord injury (i.e., AIS A, B or C). After screening for potential contraindications, participants will attend 4 experimental sessions. In each session, their sensory or reflex function will be tested at regular intervals. Once baseline recordings are established, participants will be given either room air or 99% oxygen to breathe through a face mask for 2 minutes. It will be determined if breathing 99% oxygen results in a change in the sensory and motor functions recorded before and shortly after breathing oxygen.
Administration of a high concentration of oxygen at atmospheric pressure for a short duration has been completed without adverse effects in healthy individuals, and individuals with various forms of injury including chronic obstructive lung disease, traumatic brain injury, stroke, and spinal cord injury. Duration of administration has ranged from 3 min to 4 hours without adverse effects.
If this initial trial indicates that improvements in sensory and motor function are induced by this short exposure, exploration of therapeutic ways to increase blood flow to the spinal cord will be undertaken
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 25 is close to the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408
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.
Drug: Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408
Participants will receive oxygen (99%) or room air (placebo) delivered through a face mask at a flow rate of 10 litres/min for 2 minutes. The participants will be exposed twice to both conditions over 4 experiments at a minimum of 2 week intervals between each testing session.
Also known as: Compressed air from Praxair, DIN# 02014483
Skin Sensation
Quantification using von Frey Hairs at three locations above and below the level of injury.
Time frame: Pre-intervention (exposure to high oxygen)
Skin Sensation
Quantification using von Frey Hairs at three locations above and below the level of injury.
Time frame: Immediately after intervention (exposure to high oxygen)
Skin Sensation
Quantification using von Frey Hairs at three locations above and below the level of injury.
Time frame: Pre-intervention (exposure to room air)
Skin Sensation
Quantification using von Frey Hairs at three locations above and below the level of injury.
Time frame: Immediately after intervention (exposure to room air)
Reflex Excitability
Elicited by electrical stimulation of the skin on the arch of the foot and measured by surface electromyography (EMG).
Time frame: Pre-intervention (exposure to high oxygen)
Reflex Excitability
Elicited by electrical stimulation of the skin on the arch of the foot and measured by surface electromyography (EMG).
Time frame: Immediately after intervention (exposure to high oxygen)
Reflex Excitability
Elicited by electrical stimulation of the skin on the arch of the foot and measured by surface electromyography (EMG).
Time frame: Pre-intervention (exposure to room air)
Reflex Excitability
Elicited by electrical stimulation of the skin on the arch of the foot and measured by surface electromyography (EMG).
Time frame: Immediately after intervention (exposure to room air)
Plan to share: No
Started Jul 2022 (actual). Primary completion is estimated for Dec 2026, 53 months after the start.
Of 40 non-industry phase 1 interventional studies under Spinal Cord Injuries, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 55. This study's planned 53 months is above that.
Counting every sponsor, half of 51 studies reached it within 36 months; a quarter within 24 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
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