Intermittent Hypoxia Therapy for Spinal Cord Injury

Overseen By Stella Barth, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

Disqualifiers: Cardiovascular disease, Osteoporosis, Pregnancy, others

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

Compensation: Varies

Number of Visits: 8

Duration: 1 week

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to determine how the nervous system controlling leg muscles is altered following spinal cord injury and how they may be affected by brief periods of low oxygen inhalation over time.

The investigators hypothesize:

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

* AIH exposure will increase multijoint reflex excitability of leg muscles in persons with incomplete cervical SCI

* AIH exposure will increase walking performance in persons with incomplete cervical SCI

Who Is on the Research Team?

Randy D Trumbower, PT, PhD

Principal Investigator

Spaulding Rehabilitation Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with incomplete spinal cord injury from C2-L5, medically stable and able to take a step without help. It's been over 6 months since their injury. People can't join if they have heart or lung issues, are in physical therapy, have severe pain or infections, fractures due to osteoporosis, leg nerve damage, cognitive impairment (score <24 on Mini-Mental), are pregnant or at risk of frequent autonomic dysreflexia.

Inclusion Criteria

It has been over 6 months since my spinal cord injury.

I can walk and take a step without help from another person.

I have a spinal cord injury that is not getting worse, between my neck and lower back.

Exclusion Criteria

I do not have severe ongoing illnesses like unhealed wounds, chronic pain, heart disease, weak bones with fractures, abnormal bone growth, or nerve damage in my legs.

You scored less than 24 on the Mini-mental Exam.

I have experienced repeated episodes of sudden high blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo daily sessions of intermittent hypoxia for 5 consecutive days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for changes in walking speed and endurance

4 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Acute Intermittent Hypoxia
• SHAM - Intermittent Room Air

Trial Overview The study tests how low oxygen periods (AIH) affect leg muscle control and strength in people with cervical spinal cord injuries compared to normal air breathing (SHAM). The goal is to see if AIH improves voluntary leg strength, reflexes in the legs, and walking ability.

How Is the Trial Designed?

Group I: Intermittent Hypoxia (AIH) Active Control 1 Intervention

Subjects with chronic, motor-incomplete SCI will breath mild bouts of low oxygen. Intervention: AIH - Intermittent Hypoxia - hypoxia air mixture Dosage: 10% oxygen Frequency: 1.5 minutes bouts of low oxygen with 1.0 minute intervals of room air Duration: 38 minutes

Group II: Intermittent Room Air (SHAM) Placebo Group 1 Intervention

Subjects with chronic, motor-incomplete SCI will breath mild bouts of room air. Intervention: SHAM - Intermittent Room Air - room air mixture Dosage: 21% oxygen Frequency: 1.5 minutes bouts of room air with 1.0 minute intervals also of room air Duration: 38 minutes

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

Foundation Wings For Life

Collaborator

Trials

14

Recruited

1,200+