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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05467215
• Other study ID #: Pro00061817
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 11, 2022
• Est. completion date: November 1, 2025

Study information

• Verified date: July 2023
• Source: University of Alberta
• Contact: Michelle Barnes, PT
• Phone: 780-492-4858
• Email: carre[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperoxia
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Alberta, Clinical Sciences Bldg	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

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