Can Brief Exposure to Hyperoxia Improve Function After Chronic Spinal Cord Injury?

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).

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Drug: Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408

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

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Michelle Barnes, PT; Phone Number: 780-492-4858; Email: carre@ualberta.ca
• Study Contact Backup: Name: Jaynie Yang, PT, PhD; Phone Number: 7804922894; Email: jaynie@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Recruiting
      • University of Alberta, Clinical Sciences Bldg
      • Contact: Michelle Barnes; Phone Number: 7804055917; Email: carre@ualberta.ca
      • Contact: Jaynie Yang; Phone Number: 7804922894; Email: jaynie@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyperoxia followed by room air; 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; 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
Placebo Comparator: Room air followed by hyperoxia; 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.; Other Names: Compressed air from Praxair, DIN# 02014483

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Sensation	Quantification using von Frey Hairs at three locations above and below the level of injury.	Pre-intervention (exposure to high oxygen)
Skin Sensation	Quantification using von Frey Hairs at three locations above and below the level of injury.	Immediately after intervention (exposure to high oxygen)
Skin Sensation	Quantification using von Frey Hairs at three locations above and below the level of injury.	Pre-intervention (exposure to room air)
Skin Sensation	Quantification using von Frey Hairs at three locations above and below the level of injury.	Immediately after intervention (exposure to room air)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reflex Excitability	Elicited by electrical stimulation of the skin on the arch of the foot and measured by surface electromyography (EMG).	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).	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).	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).	Immediately after intervention (exposure to room air)

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Jaynie Yang, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Hypoxia; Reflex; Hyperoxia; Sensation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Signs and Symptoms, Respiratory; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries; Hyperoxia
• Other Study ID Numbers: Pro00061817

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes