10 Participants NeededMy employer runs this trial

Acute Intermittent Hypoxia for Spinal Cord Injury

WZ
AB
Overseen ByAlexander Barry, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new breathing intervention called Acute Intermittent Hypoxia (AIH) to determine its effectiveness in reducing muscle tightness in individuals with incomplete spinal cord injuries. Researchers believe this breathing method might influence arm reflexes, potentially increasing spasticity (muscle stiffness or tightness). Participants will alternate between breathing low-oxygen air and regular air for about 30 minutes. This trial may suit individuals who have had a spinal cord injury for at least 6 months and experience muscle tightness. As an unphased trial, it provides a unique opportunity to explore a novel treatment approach for muscle tightness.

Will I have to stop taking my current medications?

If you are currently taking Baclofen, you will need to stop, as the trial excludes participants who are on this medication.

What prior data suggests that this breathing intervention is safe for individuals with spinal cord injury?

Research has shown that Acute Intermittent Hypoxia (AIH) is generally safe. Studies indicate that AIH is well-tolerated, with very few participants experiencing serious side effects. For instance, in one study, all 12 participants completed the AIH treatment without major issues. Another study found that AIH does not affect brain function or blood flow. Overall, AIH is considered a safe treatment option for individuals with certain conditions, such as long-term spinal cord injuries.12345

Why are researchers excited about this trial?

Unlike traditional treatments for spinal cord injury that often focus on rehabilitation and medication to manage symptoms, Acute Intermittent Hypoxia (AIH) offers a unique approach by utilizing brief periods of reduced oxygen levels followed by normal air. This method is thought to stimulate neural plasticity, potentially enhancing the body's ability to repair and adapt after injury. Researchers are excited because AIH could lead to improved functional recovery in a relatively short time, offering a promising complement to existing therapies like physical therapy and pharmaceuticals.

What evidence suggests that Acute Intermittent Hypoxia is effective for spasticity in spinal cord injury?

Research has shown that Acute Intermittent Hypoxia (AIH), which involves breathing air with reduced oxygen for short periods, can enhance muscle strength and function in individuals with partial spinal cord injuries. Studies have found that AIH therapy can increase strength in the hands and legs and improve overall movement. Some research also suggests it can enhance breathing ability. However, about 40% of individuals may not experience significant improvement with AIH. Despite this, AIH remains a promising method for aiding recovery in spinal cord injury patients.678910

Who Is on the Research Team?

WZ

William Z Rymer, MD, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for people with incomplete spinal cord injury who experience muscle tightness (spasticity). Participants should not have conditions that would make the breathing intervention unsafe, but specific inclusion and exclusion details are not provided.

Inclusion Criteria

Level of injury between C1-C8
ISNCSCI ASIA classification C or D
I am 18 years old or older.
See 2 more

Exclusion Criteria

I was diagnosed with Covid-related pneumonia in the past year.
History of epilepsy
I have had a heart attack in the past.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Acute Intermittent Hypoxia (AIH) intervention, involving alternating bouts of lowered oxygen and room air for approximately 30 minutes

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in reflex threshold, spasticity, and grip strength after the AIH intervention

1 day

What Are the Treatments Tested in This Trial?

Interventions

  • Acute Intermittent Hypoxia (AIH)

Trial Overview

The study tests a special breathing technique called Acute Intermittent Hypoxia (AIH) to see how it affects muscle tightness in people with partial paralysis from spinal cord injury. Researchers will measure changes in arm muscle reflexes after AIH.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: AIH interventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Zev Rymer

Lead Sponsor

Citations

Efficacy and time course of acute intermittent hypoxia effects in ...

AIH therapy is a promising technique to elicit spinal plasticity and drive functional recovery. Here we show that AIH improves hand strength in persons with ...

Effects of acute intermittent hypoxia on muscle strength in ...

AHI has a potential benefit in improving muscle strength post-SCI. · Motor incomplete SCIs are more likely to benefit from the AIH intervention. · AIH should be ...

Acute intermittent hypoxia as a potential adjuvant to improve ...

Recent studies provide foundational support that AIH also induces improvements in breathing capacity, lower limb, and upper limb function in persons with SCI ( ...

Researchers Receive $3.6 Million Grant for Study to ...

However, research shows that 40% of individuals show minimal response to the benefits of AIH treatment. With the support of a four-year, $3.6 ...

The effect of acute intermittent hypoxia on enhancing motor ...

Recent studies have demonstrated that AIH improves breathing capacity as well as motor function in individuals with incomplete spinal cord ...

Safety and potential benefits of acute intermittent hypoxia in ...

All 12 participants with TBI recruited into the study complied with the entire AIH treatment protocol without serious AEs at any treatment ...

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 ...

Acute Intermittent Hypoxia on Leg Function Following ...

Acute intermittent hypoxia (AIH) exposure will increase maximum voluntary leg strength in persons with incomplete cervical spinal cord injury (SCI); AIH ...

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 ...

Acute Intermittent Hypoxia in People Living With Chronic ...

AIH is potentially safe and effective for improving strength in the more-affected limb in people living with hemiparetic stroke.