We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acute Intermittent Hypoxia on Leg Function Following Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02274116
Recruitment Status : Recruiting
First Posted : October 24, 2014
Last Update Posted : June 27, 2022
Sponsor:
Collaborator:
Foundation Wings For Life
Information provided by (Responsible Party):
Randy Trumbower, PT, PhD, Spaulding Rehabilitation Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: SHAM - Intermittent Room Air - room air mixture Other: AIH - Intermittent Hypoxia - hypoxia air mixture Not Applicable

Detailed 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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Exposure of Intermittent Hypoxia to Enhance Walking Recovery in Persons With Chronic Spinal Cord Injury
Study Start Date : October 2014
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Intermittent Hypoxia (AIH)

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

 Other: AIH - Intermittent Hypoxia - hypoxia air mixture
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 5 times per week for 2 weeks.
Sham Comparator: Intermittent Room Air (SHAM)

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

 Other: SHAM - Intermittent Room Air - room air mixture
Participants will breathe intermittent room air 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)=0.21±0.02 (normoxia). Participants will receive treatment 5 times per week for 2 weeks.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in overground walking endurance [ Time Frame: Baseline, immediately following intervention (day 5), and at 1, 2, and 4 weeks ]
    walking endurance (6 minute walk test - how far one can walk in 6 minutes)


Secondary Outcome Measures :
  1. Change in overground walking speed [ Time Frame: Baseline, immediately following intervention (day 5), and at 1, 2, and 4 weeks ]
    walking speed (10 meter walk test - how fast one can walk in 10 meters)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02274116


Contacts
Layout table for location contacts
Contact: Randy D Trumbower, PT, PhD 617-952-6951 randy.trumbower@mgh.harvard.edu
Contact: Stella Barth, BA 617-952-6822 sbarth@partners.org

Locations
Layout table for location information
United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Randy D Trumbower, PT, PhD    617-952-6951    randy.trumbower@mgh.harvard.edu   
Contact: Melissa DeChellis    (617) 952-6953    mpierre19@partners.org   
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Foundation Wings For Life
Investigators
Layout table for investigator information
Principal Investigator: Randy D Trumbower, PT, PhD Spaulding Rehabilitation Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Randy Trumbower, PT, PhD, Assistant Professor, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT02274116    
Other Study ID Numbers: 2017P001940c
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: June 27, 2022
Last Verified: June 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Randy Trumbower, PT, PhD, Spaulding Rehabilitation Hospital:
acute intermittent hypoxia
walking
spasticity
 incomplete spinal cord injury
breathing
strength
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Hypoxia
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Signs and Symptoms, Respiratory