Spinal Cord Injuries
Conditions
Keywords
Hypoxia, Hyperoxia, Reflex, Sensation
Brief summary
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).
Detailed description
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
Interventions
DRUGPure 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.
Sponsors
University of Alberta
Canadian Institutes of Health Research (CIHR)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participants with SCI will be masked. The experimenter collecting the sensory data and the experimenter analyzing the reflex data will be masked to the oxygen/air exposure, to avoid bias. The participant and the experimenter will be unmasked once all data collection has been completed for the participant.
Intervention model description
Prospective, double-blind, randomized crossover design
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Individuals with traumatic SCI with onset ≥3 months prior, 2. Between 18 - 65 yr old, 3. ASIA Impairment Scale at discharge classified as A, B or C, 4. Injury level between C5 and T10, 5. Able to give informed, written consent.
Exclusion criteria
1. Frequent uncontrolled autonomic dysreflexia, 2. Uncontrolled high blood pressure, 3. Cardiac or cardiovascular disease, 4. Cancer, 5. Active urinary tract infection, 6. Active pressure sores, 7. Signs of deep vein thrombosis in the legs, 8. Severe swelling of the feet and/or legs, 9. Severe cognitive impairment, 10. Pulmonary dysfunction such as chronic obstructive pulmonary disease or acute respiratory infection, 11. Any condition which would be exacerbated by sitting or lying in one position for 2 hours, such as low back pain 12. Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Sensation | Pre-intervention (exposure to high oxygen) | Quantification using von Frey Hairs at three locations above and below the level of injury. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reflex Excitability | 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). |
Countries
Canada
Contacts
CONTACTMichelle Barnes, PT
CONTACTJaynie Yang, PT, PhD
PRINCIPAL_INVESTIGATORJaynie Yang
University of Alberta
Outcome results
None listed