Intermittent Hypoxia Therapy for Spinal Cord Injury

Palo Alto (17 mi)

Overseen byRandy D Trumbower, PT, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Spaulding Rehabilitation Hospital

No Placebo Group

Trial Summary

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

Eligibility Criteria

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

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.

I have experienced repeated episodes of sudden high blood pressure.

I have heart or lung problems.

Treatment Details

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.

2Treatment groups

Active Control

Placebo Group

Group I: Intermittent Hypoxia (AIH)Active Control1 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 Group1 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