Acute Intermittent Hypoxia on Leg Function Following Spinal Cord Injury

  • STATUS
    Recruiting
  • End date
    Aug 23, 2022
  • participants needed
    20
  • sponsor
    Spaulding Rehabilitation Hospital
Updated on 23 June 2021
hypoxia
spinal cord
cervical spinal cord injury
nervous
spinal cord disorder
neurologic findings

Summary

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

Description

Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) is a safe and effective treatment strategy to promote meaningful functional recovery in persons with chronic spinal cord injury. Repetitive exposure to mild hypoxia triggers a cascade of events in the spinal cord, including new protein synthesis and increased sensitivity in the circuitry necessary for breathing and walking. Recently, the investigators demonstrated that daily (5 consecutive days) of intermittent hypoxia stimulated walking enhancement in persons with chronic spinal cord injury.

Despite these exciting findings, important clinical questions remain. For example, the investigators do not know if prolonged, but less intense intermittent hypoxia induces longer-lasting motor recovery as has been shown in rat models. The investigators hypothesize that repetitive exposures to modest bouts of low oxygen will enhance and prolong walking recovery in persons with chronic spinal cord injury. The investigators anticipate intermittent hypoxia-induced improvements in overground walking ability, likely due to greater balance in excitatory and inhibitory neural transmission. Whereas excitatory inputs drive walking, inhibitory inputs sculpt and coordinate muscle activity; yet so often remain compromised after chronic injury. Thus, the investigators also predict that repetitive exposures to intermittent hypoxia will result in improved inhibition and subsequently enhance muscle coordination during walking. The investigators will use multiple experimental approaches, including muscle electromyography, measurements of walking dynamics and stretch reflexes. Finally, it is critical to assure that repetitive exposures to intermittent hypoxia do not elicit pathologies characteristic of more severe, chronic hypoxia experienced by individuals with obstructive sleep apnea. The investigators will confirm that repetitive exposure to mild bouts of intermittent hypoxia is safe.

Details
Condition Spinal Cord Injury, Myelopathy, Trauma, Spinal Cord Injuries, Wounds, Spinal Cord Disorders
Treatment SHAM - Intermittent Room Air - room air mixture, AIH - Intermittent Hypoxia - hypoxia air mixture
Clinical Study IdentifierNCT02274116
SponsorSpaulding Rehabilitation Hospital
Last Modified on23 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

to 75 years old (the latter to reduce likelihood of heart disease)
medically stable with clearance from physician to participate
motor---incomplete SCI at C2---L5 with non---progressive etiology
>6 months since SCI to ensure minimal confounds of spontaneous neurological recovery
those classified as ambulatory must have the ability to advance one step overground without human assistance

Exclusion Criteria

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
less than 24 on the Mini-mental Exam
recurrent autonomic dysreflexia
cardiopulmonary complications
concurrent physical therapy
pregnancy because of unknown effects of AIH on a fetus, although women will not otherwise be excluded
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