Can Brief Exposure to Hyperoxia Improve Function After Chronic Spinal Cord Injury?
ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Alberta
About 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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Individuals with traumatic SCI with onset ≥3 months prior,
Between 18 - 65 yr old,
ASIA Impairment Scale at discharge classified as A, B or C,
Injury level between C5 and T10,
Disqualifiers
Frequent uncontrolled autonomic dysreflexia,
Uncontrolled high blood pressure,
Cardiac or cardiovascular disease,
Cancer,
Trial design
Design model
Crossover
Treatments tested in this trial
Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408
DrugParticipants 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.
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Hyperoxia followed by room airExperimental treatment 1 intervention
Group B: Room air followed by hyperoxiaPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)3
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)4
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alberta
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov