University of Alberta, Clinical Sciences Bldg
Edmonton, Alberta, T6G 2B7, Canada
Location status: Recruiting
Location contact
Jaynie Yang
CONTACT
Michelle Barnes
CONTACT
NCT Number: NCT05467215
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).
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Early Phase 1
Edmonton, Alberta, T6G 2B7, Canada
Location status: Recruiting
Jaynie Yang
CONTACT
Michelle Barnes
CONTACT
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Compressed air from Praxair, DIN# 02014483
Time frame: Pre-intervention (exposure to high oxygen)
Quantification using von Frey Hairs at three locations above and below the level of injury.
Time frame: Immediately after intervention (exposure to high oxygen)
Quantification using von Frey Hairs at three locations above and below the level of injury.
Time frame: Pre-intervention (exposure to room air)
Quantification using von Frey Hairs at three locations above and below the level of injury.
Time frame: Immediately after intervention (exposure to room air)
Quantification using von Frey Hairs at three locations above and below the level of injury.
Time frame: Pre-intervention (exposure to high oxygen)
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)
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)
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)
Elicited by electrical stimulation of the skin on the arch of the foot and measured by surface electromyography (EMG).
Contact information is provided by the study sponsor or research team.
Jaynie Yang, PT, PhD
CONTACT
Michelle Barnes, PT
CONTACT
University of Alberta
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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