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Hyperoxia for Spinal Cord Injury

Phase < 1

Recruiting

Led By Jaynie Yang

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ASIA Impairment Scale at discharge classified as A, B or C

Injury level between C5 and T10

Must not have

Any condition which would be exacerbated by sitting or lying in one position for 2 hours, such as low back pain

Uncontrolled high blood pressure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after intervention (exposure to room air)

Awards & highlights

Summary

This trial will test if higher levels of oxygen improve movement and sensation in people with spinal cord injuries.

Who is the study for?

This trial is for adults aged 18-65 with severe spinal cord injuries between C5 and T10, which occurred at least 3 months ago. Participants must have an ASIA Impairment Scale rating of A, B, or C at discharge and be able to consent. It's not suitable for those with conditions worsened by remaining still for long periods, UTIs, cognitive impairments, cancer, pressure sores, uncontrolled autonomic dysreflexia or blood pressure issues.

What is being tested?

The study tests if breathing pure oxygen (99%) can improve sensory and motor functions in individuals with chronic severe spinal cord injury. The oxygen used is from Praxair (DIN# 02014408), and the goal is to see if hyperoxia leads to functional changes compared to normal air concentration.

What are the potential side effects?

While specific side effects are not listed for this trial of hyperoxia exposure in SCI patients, generally potential risks may include lung damage due to high oxygen levels over time or temporary visual changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My spinal cord injury severity is classified as A, B, or C.

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My spinal cord injury is between my neck and mid-back.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I can sit or lie down for 2 hours without worsening any condition like low back pain.

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My high blood pressure is not under control.

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I currently have a urinary tract infection.

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I often have sudden and severe high blood pressure.

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I have lung problems like COPD or a recent lung infection.

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I have significant memory or thinking problems.

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I have active pressure sores.

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I have heart or blood vessel disease.

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I have severe swelling in my feet or legs.

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I have signs of a blood clot in my leg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after intervention (exposure to room air)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after intervention (exposure to room air)

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after intervention (exposure to room air) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Skin Sensation

Secondary study objectives

Reflex Excitability

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Hyperoxia followed by room airExperimental Treatment1 Intervention

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.

Group II: Room air followed by hyperoxiaPlacebo Group1 Intervention

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.

0 / 13Eligibility criteria met

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Who is running the clinical trial?

University of AlbertaLead Sponsor

913 Previous Clinical Trials

390,408 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,373 Previous Clinical Trials

26,519,217 Total Patients Enrolled

Jaynie YangPrincipal InvestigatorUniversity of Alberta

1 Previous Clinical Trials

18 Total Patients Enrolled

Media Library

Pure oxygen (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05467215 — Phase < 1

Spinal Cord Injury Research Study Groups: Room air followed by hyperoxia, Hyperoxia followed by room air

Spinal Cord Injury Clinical Trial 2023: Pure oxygen Highlights & Side Effects. Trial Name: NCT05467215 — Phase < 1

Pure oxygen (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05467215 — Phase < 1

~8 spots leftby Nov 2025

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