Image

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

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

Recruiting
18-65 years
All
Phase N/A

Powered by AI

Overview

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

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.

Study details
    Spinal Cord Injuries

NCT05467215

University of Alberta

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.