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Intermittent Hypoxia Therapy for Spinal Cord Injury

N/A

Waitlist Available

Led By Randy D Trumbower, PT, PhD

Research Sponsored by Spaulding Rehabilitation Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Those classified as ambulatory must have the ability to advance one step overground without human assistance

Motor---incomplete SCI at C2---L5 with non---progressive etiology

Must not have

Concurrent illness, including unhealed decubiti, severe neuropathic or chronic pain syndrome, infection, cardiovascular disease, osteoporosis (history of fractures), active heterotopic ossification, or known history of peripheral nerve injury to legs

Recurrent autonomic dysreflexia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, immediately following intervention (day 5), and at 1, 2, and 4 weeks

Summary

This trial will test the effects of acute intermittent hypoxia on leg muscle strength, reflexes, and walking in people with incomplete cervical spinal cord injury.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from wearing a mask for gas delivery and risks associated with brief low oxygen levels such as lightheadedness or fainting. However specific side effect details aren't provided.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

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I have experienced repeated episodes of sudden high blood pressure.

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I have heart or lung problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, immediately following intervention (day 5), and at 1, 2, and 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, immediately following intervention (day 5), and at 1, 2, and 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately following intervention (day 5), and at 1, 2, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in overground walking endurance

Secondary study objectives

Change in overground walking speed

Trial Design

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

0 / 5Eligibility criteria met