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Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03071393
Recruitment Status : Recruiting
First Posted : March 6, 2017
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Description
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Brief Summary:
This study will examine if acute intermittent hypoxia (brief episodes of breathing lower oxygen), which has been shown to enhance plasticity and motor output, can enhance functional outcomes and muscle activation in individuals with spinal cord injury. Our aim is to assess breathing, sitting, standing and walking functional ability before and after acute intermittent hypoxia, compared to a sham treatment. This information may be useful in advancing rehabilitation for people with spinal cord injuries.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Hypoxico Hyp-123 Not Applicable

Detailed Description:

Recent evidence has shown that acute intermittent hypoxia can strengthen motor pathways after spinal cord injury, and enhance walking outcomes after walking rehabilitation compared to walking rehabilitation alone. A single session of acute intermittent hypoxia has also been shown to temporarily enhance breathing and limb strength in people with spinal cord injury. Further evidence supports the hypothesis that acute intermittent hypoxia acts on all motor pathways, and thus can enhance the strength of most muscles in the body.

Spinal cord injury affects the trunk muscles that control respiration and posture. Decreased respiratory muscle function can lead to diseases of the respiratory system, which are the primary cause of death and significant cause of re-hospitalization after spinal cord injury. Deficits in postural muscle function affect one's ability to balance, safely maintain a seated position, or ambulate after spinal cord injury, severely impacting daily activities such as self-care and feeding skills.

This study will test the hypothesis that a single session of acute intermittent hypoxia will increase strength and activation of the trunk muscles that control respiration and posture, leading to improved scores on functional assessments in individuals with chronic spinal cord injury. Our long term goal is to better understand the therapeutic potential of acute intermittent hypoxia combined with physical rehabilitation for individuals with chronic spinal cord injury.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Masking Description: Subjects will be asked to participate in two visits at least 7 days apart. Subjects will be assessed on various clinical outcomes before and after an exposure to one of two treatments. In one visit, subjects will be assessed before and after acute intermittent hypoxia, consisting of brief exposures of breathing low oxygen air, alternated with brief exposures to room air. In the other visit, subjects will be assessed before and after an exposure to a sham treatment, consisting of breathing brief exposures of normal oxygen air, alternated with brief exposures to room air. Subjects will undergo acute intermittent hypoxia or a sham treatment in a randomized order.
Primary Purpose: Treatment
Official Title: Acute Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury
Actual Study Start Date : July 10, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Acute Intermittent Hypoxia
Subjects with chronic spinal cord injury will undergo an acute intermittent hypoxia protocol with low oxygen air (9-15% inspired oxygen.
 Device: Hypoxico Hyp-123
During acute intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of low oxygen air (9-15% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.
Other Name: Altitude Generator
Sham Comparator: Sham Intermittent Hypoxia
Subjects with chronic spinal cord injury will undergo a sham placebo protocol with normal oxygen air (21% inspired oxygen).
 Device: Hypoxico Hyp-123
During sham intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of normal oxygen air (21% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.
Other Name: Altitude Generator


Outcome Measures
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Primary Outcome Measures :
  1. Change in Neuromuscular Recovery Scale seated component scores [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]

    The degree to which subjects can independently perform certain tasks that require trunk muscles will be assessed with the Neuromuscular Recovery Scale. Four components of this standard, reliable and responsive clinical test of functional ability for people with SCI will be used. Standardized instructions will be provided to the subjects for each component. These components include:

    1. Sit - testing the subject's ability to sit tall with proper posture when the feet are flat on the floor.
    2. Reverse Sit-up - subjects will be asked to lower themselves from sitting up to lying supine on a mat as slowly and controlled as possible.
    3. Sit-up - the subject's ability to sit up from lying supine on a table while the feet are on the ground will be assessed.
    4. Trunk extension in sitting - while seated on a table with feet on the floor, subjects will be asked to lean forward with their arms hanging down, and then return to a seated position without using their hands.

  2. Change in Maximal Inspiratory Pressure [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of inspiration strength, assessed using a digital respiratory pressure meter.

  3. Change in Maximal Expiratory Pressure [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of expiration strength, assessed using a digital respiratory pressure meter.

  4. Change in Forced Vital Capacity [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of how much air a person can forcefully exhale after a maximal inspiratory effort. Tests are conducted using a digital spirometer or respiratory monitor.

  5. Change in Mouth Occlusion Pressure (P0.1) [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of the pressure generated in the first 0.1 seconds of the participant's initiation of inhalation.Up to 10 trials of mouth occlusion pressure (P0.1) will be measured to ensure a valid measurement.

  6. Change in postural strength in sitting [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    Assessed by asking subjects to remain sitting upright while a study staff member applies force to the participant's upper chest, shoulders, or back using a hand-held force meter to record the amount of resistance provided by the participant. Participants will be spotted as necessary by study staff in case the participant is unable to balance themselves during the test.


Secondary Outcome Measures :
  1. Electromyography (EMG) of trunk and accessory respiratory muscles. [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    Activation and timing of activation of trunk and other accessory respiratory muscles will be measured using EMG, which are small sensors that attach to the skin.

  2. Trunk and hip angles and position during assessments [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    Electrogoniometers, sensors used to calculate joint angles, may be placed on the hips or the trunk to allow for measurement of the angle of those segments during each assessment task.

  3. Timed Up and Go test [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of walking balance and fall risk based on the participant's ability to stand up from a seated position, walk 10 meters, turn around, return to their chair and sit down. This test will only be performed by subjects who can safely attempt it.

  4. 10 Meter Walk test [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of walking speed over a distance of 10 meters. This test will only be performed by subjects who can safely attempt it.

  5. 30 Second Chair Stand test [ Time Frame: Change between baseline- and 30 minutes post-intermittent hypoxia or sham. ]
    An assessment of lower body strength and power which evaluates the maximum amount of times that a participant can safely stand up from a seated position and sit back down. This test will only be performed by subjects who can safely attempt it.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Male or female, ages 18-65
  2. Greater than 6 months post-spinal cord injury
  3. Spinal cord injury affecting segments between C4-T12
  4. No other known neurological disorders
  5. Able to provide informed consent
  6. no severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments.

Exclusion criteria:

  1. Presence of a self-reported uncontrolled medical condition including, but not limited to: cardiovascular disease; sleep apnea; obstructive lung disease; severe neuropathic or chronic pain; severe recurrent autonomic dysreflexia
  2. Severe, untreated bladder or urinary tract infection
  3. Presence of severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments
  4. Women who report being pregnant or test positive on a pregnancy test
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071393


Contacts
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Contact: Thomas W. Sutor, MS (352) 273-6117 tsutor@ufl.edu
Contact: Emily J. Fox, PT, DPT, PhD (352) 273-6117 ejfox@phhp.ufl.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Thomas W Sutor, MS       tsutor@ufl.edu   
Brooks Rehabilitation Recruiting
Jacksonville, Florida, United States, 32216
Contact: Emily J. Fox, PT, DPT, PhD    904-742-2500    ejfox@phhp.ufl.edu   
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Emily J Fox, PT, DPT, PhD University of Florida
More Information
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Publications:

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03071393    
Other Study ID Numbers: IRB201601680
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Florida:
acute intermittent hypoxia
walking
breathing
 standing
sitting
spinal cord injury
Additional relevant MeSH terms:
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Spinal Cord Injuries
Hypoxia
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Signs and Symptoms, Respiratory