RecruitingEARLY_PHASE1INTERVENTIONAL

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

This study is for adults with traumatic spinal cord injury. We are studying whether breathing a high level of oxygen for a very short time can cause short-term changes in sensation or muscle activity after spinal cord injury. Participants will attend the University of Alberta research site in Edmonton for an in-person screening visit and two experimental sessions. During the experimental sessions, participants will breathe either oxygen or room air through a face mask for 2 minutes. The research team will measure skin sensation and muscle activity before and after the exposure. This study is not a treatment study. Participants are not expected to benefit directly from taking part. The results may help researchers decide whether this area should be studied further in future rehabilitation research.

At a glance

Status

Recruiting

Phase

EARLY_PHASE1

Sponsor

University of Alberta

Enrolment target

Start

11 Jul 2022

Estimated completion

31 Dec 2026

Spinal Cord Injuries

What is this study about?

This study is called 'Can Brief Exposure to Hyperoxia Improve Function After Chronic Spinal Cord Injury?'. In simple terms, it's asking if giving someone a short amount of extra oxygen can help people who’ve had a spinal cord injury for a while. We know that oxygen is vital for our bodies to work properly, and researchers are curious if bumping up the oxygen level in the air we breathe might make a difference in how well the spinal cord and nerves communicate.

The main idea behind this research is to see if breathing more oxygen than usual, even for just two minutes, can change how people with spinal cord injuries feel and move. This is a "proof-of-principle" study, which means it's a very early step. The scientists want to see if this idea even works at all before they think about developing it further. They will compare what happens when someone breathes pure oxygen to when they breathe regular air, looking for any small improvements.

If this initial study shows promising results – meaning that breathing oxygen appears to improve feeling and movement – it could open doors for new ways to treat spinal cord injuries in the future. The ultimate goal is to find safe and effective methods to help the body heal and improve function after these types of injuries.

Key takeaways

Looks at if short bursts of oxygen help long-term spinal cord injury.
Breathes pure oxygen for only two minutes through a mask.
Compares feeling and movement before and after oxygen.
This is an early, 'first-look' study to test a new idea.
Aims to find new ways to improve recovery from spinal cord injury.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old who has had a traumatic spinal cord injury for at least three months. Your injury must be at a specific level, between C5 and T10, and be classified as severe (AIS A, B, or C) by your doctors. You also need to be able to understand the study and give your written permission to take part.

There are certain health conditions that would prevent you from joining. For example, if you have frequent uncontrolled ups and downs in your blood pressure (autonomic dysreflexia), uncontrolled high blood pressure, or heart and blood vessel problems, you wouldn't be able to participate. Having active serious infections like a urinary tract infection or pressure sores, or signs of blood clots in your legs, would also mean you couldn't join.

Other reasons you might not be able to take part include having cancer, problems with your lungs (like severe asthma or a recent chest infection), very swollen legs, or significant memory and thinking problems. If you have conditions that would make it hard for you to sit or lie still for two hours, such as certain types of back pain, or if you are pregnant, you also wouldn't be eligible for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Was your spinal cord injury at least 3 months ago?
Is your spinal cord injury between C5 and T10?
Do you not have active infections like a UTI or pressure sores?
Do you not have serious heart or lung conditions?
Are you able to sit or lie still for about 2 hours?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would come to a clinic for four separate visits. During each visit, researchers will carefully measure your feeling (sensory function) and movement (motor function) at different times. After these initial measurements, you will wear a mask and either breathe normal room air or pure oxygen (99%) for only two minutes. The medical team will then take more measurements to see if breathing the oxygen caused any changes in your feeling and movement. Each session will focus on comparing your abilities before and shortly after breathing either the oxygen or regular air. The total time for each visit and the overall duration of your involvement in the study is not specified but will be explained in detail if you are interested.

Potential risks and benefits

This study is in its very early stages, so the main goal is to see if this treatment even works. There might not be a direct benefit to you personally, but any information gained could help doctors understand how to treat spinal cord injuries in the future. Breathing high concentrations of oxygen for a short time has been done safely in healthy people and those with various injuries, without causing serious problems. The oxygen used is a standard medical gas. However, as with any study, there's always a small chance of unexpected side effects, and you have the right to withdraw from the study at any time without giving a reason.

Locations (1)

University of Alberta, Clinical Sciences Bldg
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What is 'chronic' spinal cord injury?

Chronic means your spinal cord injury happened at least three months ago.

What does 'pure oxygen' mean in this study?

It means you will breathe air that is 99% oxygen, much more than the 21% found in normal air.

How long will I be breathing the extra oxygen?

You will breathe the pure oxygen through a face mask for just two minutes during each experiment session.

Will I feel different during the study?

The researchers will be measuring your body's responses to see if there are any changes in feeling or movement.

What is a 'proof-of-principle' study?

It's an early-stage study to see if a new idea or treatment has any positive effect at all, before further research is done.

FAQFrom the study team

Who can take part? You may be eligible if you are 18 to 65 years old and have had a traumatic spinal cord injury for at least 3 months. The study is mainly looking for people with severe spinal cord injury, with an injury level between C5 and T10. Do I need to live in Edmonton? You need to live within commuting distance of Edmonton, Alberta. The study requires in-person visits at the University of Alberta research site on different days. How many visits are required? There is one in-person screening visit and two experimental sessions. The experimental sessions are at least 2 weeks apart. What happens during the experimental sessions? You will be seated or positioned comfortably. The research team will measure skin sensation using light-touch testing and will monitor muscle activity in the legs using surface sensors. You will breathe either oxygen or room air through a face mask for 2 minutes. Measurements will be taken before and after. Will I know whether I received oxygen or room air? No. This is a blinded study, which means participants will not know which exposure they receive during each session until after their participation is complete. Will this improve my spinal cord injury? No direct benefit is expected. This study is not testing oxygen as a long-term treatment. The study is looking for short-term changes in sensation or muscle activity after a brief exposure. Are there any costs? There is no cost to participate. Parking or public transit costs are covered by the researchers.

How to find out more

Michelle Barnes

carre@ualberta.ca 7804055917 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.