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NCT Number: NCT05467215

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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,
  • Able to give informed, written consent.

Exclusion criteria

  • Frequent uncontrolled autonomic dysreflexia,
  • Uncontrolled high blood pressure,
  • Cardiac or cardiovascular disease,
  • Cancer,
  • Active urinary tract infection,
  • Active pressure sores,
  • Signs of deep vein thrombosis in the legs,
  • Severe swelling of the feet and/or legs,
  • Severe cognitive impairment,
  • Pulmonary dysfunction such as chronic obstructive pulmonary disease or acute respiratory infection,
  • Any condition which would be exacerbated by sitting or lying in one position for 2 hours, such as low back pain
  • Pregnancy.

Treatment and study plan

Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408

Drug

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

Primary outcomes

  1. Skin Sensation

    Time frame: Pre-intervention (exposure to high oxygen)

    Quantification using von Frey Hairs at three locations above and below the level of injury.

  2. Skin Sensation

    Time frame: Immediately after intervention (exposure to high oxygen)

    Quantification using von Frey Hairs at three locations above and below the level of injury.

  3. Skin Sensation

    Time frame: Pre-intervention (exposure to room air)

    Quantification using von Frey Hairs at three locations above and below the level of injury.

  4. Skin Sensation

    Time frame: Immediately after intervention (exposure to room air)

    Quantification using von Frey Hairs at three locations above and below the level of injury.

Secondary outcomes

  1. Reflex Excitability

    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).

  2. Reflex Excitability

    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).

  3. Reflex Excitability

    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).

  4. Reflex Excitability

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jaynie Yang, PT, PhD

CONTACT

[email protected]

7804922894

Michelle Barnes, PT

CONTACT

[email protected]

780-492-4858

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2022
Registry last updated
Aug 26, 2025

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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