RecruitingNot ApplicableNCT02323945

Effects of Breathing Mild Bouts of Low Oxygen on Limb Mobility After Spinal Injury

Mechanisms of Intermittent Hypoxia-induced Motor Recovery in Persons With SCI


Sponsor

Spaulding Rehabilitation Hospital

Enrollment

44 participants

Start Date

Oct 1, 2014

Study Type

INTERVENTIONAL

Conditions

Summary

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 (SCI). The goal of the study is to understand the mechanisms by which intermittent hypoxia enhances motor function and spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences) following SCI.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • Age 18 and 75 years (the latter to reduce likelihood of heart disease)
  • Medical clearance to participate
  • Lesion at or below C2 and above T12 with non-progressive etiology
  • Classified as motor-incomplete with visible volitional leg movement
  • Injury greater than 1 year

Exclusion Criteria7

  • Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of pulmonary complications)
  • Pregnant women because of the unknown affects of AIH on pregnant women and fetus
  • History of seizures, brain injury, and/or epilepsy
  • Undergoing concurrent physical therapy
  • Diabetes
  • Cirrhosis
  • Caffeine and/or NSAID allergies or intolerances

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Interventions

OTHERAIH

Participants will breathe intermittent low oxygen via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FiO2) = 0.10±0.02 (hypoxia). Participants will receive treatment on 5 consecutive days.

OTHERWalk

30 minutes of walking practice consisting of 5 repetitions of 6-minute walks

OTHERStrength

30 minutes of isometric ankle plantar flexion torque practice broken into 3 sets of 10 repetitions


Locations(1)

Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, United States

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NCT02323945


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