Low Oxygen Therapy for Spinal Cord Injury

Recruiting at 1 trial location

Overseen By Glen E Foster, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Glen Foster

Disqualifiers: Ventilator use, Neurological conditions, Cardiovascular disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 4 days

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether low oxygen therapy (LOT) can stabilize blood pressure in individuals with long-term spinal cord injuries. Participants will breathe lower oxygen levels for short periods, potentially boosting the nervous system and improving heart and blood vessel functions. The researchers aim to find ways to lower heart disease risk in those with spinal cord injuries. This trial may suit someone with a spinal cord injury at or above the T1 level, who has lived with it for over a year and does not have additional neurological conditions. As a Phase 1 and Phase 2 trial, this research focuses on understanding how the treatment works and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the research team for guidance.

What prior data suggests that low oxygen therapy is safe for individuals with spinal cord injury?

Research is exploring low oxygen therapy (LOT) for its potential benefits, but sufficient information about its safety is not yet available. This trial is in the early stages, focusing on how well participants tolerate the treatment and what side effects might occur.

While LOT remains unproven, another oxygen-based treatment, hyperbaric oxygen therapy, has shown promise in similar contexts. Studies suggest it could be a safe and effective option for spinal cord injury, though it differs from LOT.

As this trial is in the early stages, further research is necessary to fully understand LOT's safety. Participants in this study will contribute to learning more about the therapy's safety and tolerability. Those considering joining the trial should discuss potential risks and benefits with the research team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Low Oxygen Therapy (LOT) for spinal cord injury because it offers a fresh approach by using intermittent low oxygen levels to promote recovery. Unlike standard treatments, which generally focus on physical therapy and medication management to improve function and reduce symptoms, LOT potentially triggers the body's adaptive responses to low oxygen, which might aid nerve regeneration and repair. Additionally, this therapy is non-invasive and could provide benefits within a short duration, making it a promising addition to current treatment options.

What evidence suggests that low oxygen therapy might be an effective treatment for spinal cord injury?

Research has shown that low oxygen therapy (LOT), which participants in this trial will receive, might help stabilize blood pressure in people with spinal cord injuries. Early results suggest that breathing air with less oxygen can boost the body's autonomic nervous system, which controls heart rate and blood pressure. Although direct evidence on blood pressure improvements from LOT remains limited, its potential to enhance autonomic function offers hope for managing heart and blood pressure risks in this group. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals aged 19-65 living with a chronic cervical spinal cord injury at or above T1 level for at least one year and who are fluent in English.

Inclusion Criteria

I am between 19 and 65 years old.

I have had a spinal cord injury above T1 for over a year.

I am fluent in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Measurements taken at least three days before the intervention to establish baseline characteristics

3 days

1 visit (in-person)

Treatment

Participants undergo a 4-day low oxygen therapy intervention

4 days

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments immediately after the first intervention session, and at 1-day and 4-days post-intervention

1 week

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Low Oxygen Therapy (LOT)

Trial Overview The study tests if low oxygen therapy (LOT) can stabilize blood pressure over a full day in people with chronic cervical spinal cord injuries. It involves assessing heart, vascular, and autonomic functions before and after four days of LOT treatment.

How Is the Trial Designed?

Group I: Room air control; lot oxygen therapy; recovery/washout Experimental Treatment 1 Intervention

Participants with chronic cervical spinal cord injury will undergo a 4-day low oxygen therapy intervention. Measurements will first be taken at least three days before the beginning of the intervention to establish baseline characteristics, immediately before and after the first day of the intervention to assess the acute response to the intervention, and on the first and fourth days after the end of the intervention to assess persistent effects and washout.

Who Is Running the Clinical Trial?

Glen Foster

Lead Sponsor

Trials

1

Recruited

10+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06521723

NCT06521723 | Low Oxygen Therapy to Enhance Walking ... The purpose of this study is to determine how combining bouts of low oxygen, transcutaneous spinal cord stimulation, and walking training may improve walking ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1008127523000445

Advance in hyperbaric oxygen therapy in spinal cord injury Data showed that the best results are obtained with a pressure of 2.0 ATA. Exposition to 2.0 ATA for at least 1 h is necessary to saturate the venous ...

3. nature.com nature.com/articles/s41392-023-01477-6

Spinal cord injury: molecular mechanisms and therapeutic ... Effects of hyperbaric oxygen therapy on postoperative recovery after incomplete cervical spinal cord injury. Spinal Cord 60, 129–134 (2021).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11635125/

The Impact of Hyperbaric Oxygen Therapy on Functional and ... Hyperbaric oxygen therapy (HBOT) has been proven to alleviate SCI. This study aims to establish a reproducible rat model of SCI and investigate ...

5. brooksrehab.org brooksrehab.org/resources/breathing-less-oxygen-may-help-sci-survivors-breathe-better/

Breathing Less Oxygen May Help SCI Survivors ... Researchers believe that combining respiratory therapy with bouts of breathing air with less oxygen might be a solution to help them breathe better.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7717804/

Hyperbaric oxygen therapy for spinal cord injury Hyperbaric oxygen (HBO) therapy can prevent further spinal cord injury (SCI) caused by spinal cord ischemia-reperfusion injury to the maximum extent.

7. journals.sagepub.com journals.sagepub.com/doi/10.3233/BMR-200157

Effects of hyperbaric oxygen therapy on patients with spinal ... Our study suggested that HBO may positively affect the motor function and sensory function, improve the ADL, and decrease depression and anxiety of patients ...