Intermittent Hypoxia Therapy for Spinal Cord Injury

Overseen By Randy D Trumbower, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

Disqualifiers: Cardiovascular disease, Diabetes, Epilepsy, others

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

Compensation: Varies

Number of Visits: 7

Duration: 1 week

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how intermittently breathing low oxygen levels, known as Intermittent Hypoxia Therapy (AIH), can help individuals with long-term spinal cord injuries improve strength and walking ability. The study tests two approaches: one involves strength exercises after breathing sessions, and the other focuses on walking practice. Individuals with a spinal cord injury for over a year who can voluntarily move their legs might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance rehabilitation strategies for spinal cord injuries.

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 trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that breathing low oxygen levels for short periods, known as acute intermittent hypoxia (AIH), is generally safe. Studies have found that AIH does not cause lasting changes in heart and lung function, nor does it affect thinking or blood flow in the brain. Participants report that AIH is well-tolerated, with no major side effects linked to this treatment. This noninvasive therapy is also safe to use alongside physical rehabilitation exercises. Overall, AIH appears to be a safe option for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about intermittent hypoxia therapy for spinal cord injury because it offers a novel approach to rehabilitation. Unlike traditional treatments that primarily focus on physical therapy and medications to manage symptoms, this technique uses controlled periods of reduced oxygen levels to potentially enhance nerve function and recovery. The therapy is combined with strength and walking practices, which may boost muscle strength and improve walking performance more effectively than current methods. This unique mechanism of action, targeting the body's response to low oxygen, could lead to significant improvements in motor function for individuals with chronic spinal cord injuries.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

Research has shown that a treatment called intermittent hypoxia holds promise for individuals with long-term spinal cord injuries. In this trial, participants will receive acute intermittent hypoxia (AIH) combined with either strength practice or walking practice. Studies have found that just one session of AIH can enhance grip and pinch strength, with the best results appearing about three hours after treatment. Other research indicates that AIH can strengthen spinal pathways, improving physical abilities. Specifically for walking, combining five days of AIH with walking practice has increased both speed and endurance in individuals with long-term, partial spinal cord injuries. Overall, these findings suggest that AIH could effectively improve movement in people with spinal cord injuries. ^{6 7 8 9 10}

Who Is on the Research Team?

Randy D Trumbower, PT, PhD

Principal Investigator

Harvard Medical School (HMS and HSDM)

Are You a Good Fit for This Trial?

This trial is for adults aged between 18 and 75 with a chronic spinal cord injury, who can still move their legs voluntarily. They must have had the injury for over a year and be medically cleared to participate. The injury should be non-progressive and located between C2 and T12 on the spine.

Inclusion Criteria

My spinal injury is between my neck and upper back and is not getting worse.

I can move my legs on my own.

Medical clearance to participate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive acute intermittent hypoxia (AIH) with strength and walking practice over 5 consecutive days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for changes in walking speed, endurance, and muscle strength

2 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AIH
• Strength
• Walk

Trial Overview The study tests whether breathing low oxygen levels in short bursts (intermittent hypoxia) can improve limb movement and enhance nerve pathways in people with chronic spinal cord injuries. It also includes walking exercises and strength training as part of the therapy being examined.

How Is the Trial Designed?

Group I: AIH/Strength Active Control 2 Interventions

Subjects with chronic, motor-incomplete SCI receive AIH with strength practice, then AIH with walking practice and compare their efficacy on enhancing strength and/or walking performance.

Group II: AIH/Walk Active Control 2 Interventions

Subjects with chronic, motor-incomplete SCI receive acute intermittent hypoxia (AIH) with walking practice, then AIH with strength practice and compare their efficacy on enhancing strength and/or walking performance.

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Foundation Wings For Life

Collaborator

Trials

14

Recruited

1,200+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41117316/

Effect of acute intermittent hypoxia to enhance motor ... The review indicates that acute intermittent hypoxia is safe and has good treatment adherence, with low drop-out rates for acute intermittent ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S001448862100128X

Efficacy and time course of acute intermittent hypoxia ... We found that a single AIH session enhanced bilateral grip and pinch strength, and that this effect peaked ~3 h post-intervention.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02441179

Acute Intermittent Hypoxia and Body Weight Supported ... In recent years, considerable evidence has demonstrated that acute intermittent hypoxia (AIH) elicits plasticity in the spinal cord and strengthens spare ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4475712/

Efficacy of Acute Intermittent Hypoxia on Physical Function ... A promising approach to improve physical function in persons with SCI is exposure to acute intermittent hypoxia (IH) in the form of a small amount of sessions ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0197486

Acute intermittent hypoxia and rehabilitative training following ... Both 1 or 7 days of AIH treatment + motor training resulted in significantly increased expression of the transcription factor hypoxia-inducible factor-1α (HIF- ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38468543/

Cardiorespiratory Responses to Acute Intermittent Hypoxia in ... In conclusion, therapeutic AIH is well tolerated, elicits variable chemoreflex activation, and does not cause persistent changes in cardiorespiratory control/ ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1569904824001514

Safety and effectiveness of acute intermittent hypoxia ... AIH is generally safe and effective for inducing neural plastic responses. · AIH does not impact cognition or cerebral perfusion rates. · AIH acutely results in a ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02274116

Acute Intermittent Hypoxia on Leg Function Following ... The investigators will confirm that repetitive exposure to mild bouts of intermittent hypoxia is safe. Official Title. Repetitive Exposure of Intermittent ...

9. medrxiv.org medrxiv.org/content/10.1101/2025.09.24.25336487v1

Safety and potential benefits of acute intermittent hypoxia ... Conclusions AIH dosage as low as 9% O2 appears safe to use in chronic TBI, but its potential benefits remain to be investigated. Competing ...

10. cdmrp.health.mil cdmrp.health.mil/scirp/research_highlights/20hypoxia_highlight

2020 Spinal Cord Injury Highlight - Acute Intermittent ... This is a relatively safe and noninvasive therapy and can be coupled with physical rehabilitation strategies to maximize effectiveness. Acute ...