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New treatment option for Spinal Cord Injuries
Official title Can Brief Exposure to Hyperoxia Improve Function After Chronic Spinal Cord Injury?
ClinicalTrials.gov ID: NCT05467215
What this study is testing
What is Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408?
Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408 is an investigational medicine, being studied as a potential treatment for spinal cord injuries.
Also referred to as Compressed air from Praxair, DIN# 02014483.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- Frequent uncontrolled autonomic dysreflexia,
- Uncontrolled high blood pressure,
- Cardiac or cardiovascular disease,
- Cancer,
- Active urinary tract infection,
- Active pressure sores,
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.