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Acute Intermittent Hypoxia on Leg Function Following Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SHAM - Intermittent Room Air - room air mixture
AIH - Intermittent Hypoxia - hypoxia air mixture
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring acute intermittent hypoxia, walking, spasticity, incomplete spinal cord injury, breathing, strength

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spaulding Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Intermittent Hypoxia (AIH)

Intermittent Room Air (SHAM)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in overground walking endurance
walking endurance (6 minute walk test - how far one can walk in 6 minutes)

Secondary Outcome Measures

Change in overground walking speed
walking speed (10 meter walk test - how fast one can walk in 10 meters)

Full Information

First Posted
October 6, 2014
Last Updated
June 24, 2022
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Foundation Wings For Life
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1. Study Identification

Unique Protocol Identification Number
NCT02274116
Brief Title
Acute Intermittent Hypoxia on Leg Function Following Spinal Cord Injury
Official Title
Repetitive Exposure of Intermittent Hypoxia to Enhance Walking Recovery in Persons With Chronic Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Foundation Wings For Life

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
acute intermittent hypoxia, walking, spasticity, incomplete spinal cord injury, breathing, strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intermittent Hypoxia (AIH)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Intermittent Room Air (SHAM)
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
SHAM - Intermittent Room Air - room air mixture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
AIH - Intermittent Hypoxia - hypoxia air mixture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in overground walking endurance
Description
walking endurance (6 minute walk test - how far one can walk in 6 minutes)
Time Frame
Baseline, immediately following intervention (day 5), and at 1, 2, and 4 weeks
Secondary Outcome Measure Information:
Title
Change in overground walking speed
Description
walking speed (10 meter walk test - how fast one can walk in 10 meters)
Time Frame
Baseline, immediately following intervention (day 5), and at 1, 2, and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Randy D Trumbower, PT, PhD
Phone
617-952-6951
Email
randy.trumbower@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Stella Barth, BA
Phone
617-952-6822
Email
sbarth@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randy D Trumbower, PT, PhD
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randy D Trumbower, PT, PhD
Phone
617-952-6951
Email
randy.trumbower@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Melissa DeChellis
Phone
(617) 952-6953
Email
mpierre19@partners.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
24285617
Citation
Hayes HB, Jayaraman A, Herrmann M, Mitchell GS, Rymer WZ, Trumbower RD. Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. Neurology. 2014 Jan 14;82(2):104-13. doi: 10.1212/01.WNL.0000437416.34298.43. Epub 2013 Nov 27.
Results Reference
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PubMed Identifier
21821826
Citation
Trumbower RD, Jayaraman A, Mitchell GS, Rymer WZ. Exposure to acute intermittent hypoxia augments somatic motor function in humans with incomplete spinal cord injury. Neurorehabil Neural Repair. 2012 Feb;26(2):163-72. doi: 10.1177/1545968311412055. Epub 2011 Aug 5.
Results Reference
background
PubMed Identifier
22423083
Citation
Lovett-Barr MR, Satriotomo I, Muir GD, Wilkerson JE, Hoffman MS, Vinit S, Mitchell GS. Repetitive intermittent hypoxia induces respiratory and somatic motor recovery after chronic cervical spinal injury. J Neurosci. 2012 Mar 14;32(11):3591-600. doi: 10.1523/JNEUROSCI.2908-11.2012.
Results Reference
background
PubMed Identifier
20536940
Citation
Dale-Nagle EA, Hoffman MS, MacFarlane PM, Satriotomo I, Lovett-Barr MR, Vinit S, Mitchell GS. Spinal plasticity following intermittent hypoxia: implications for spinal injury. Ann N Y Acad Sci. 2010 Jun;1198:252-9. doi: 10.1111/j.1749-6632.2010.05499.x.
Results Reference
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Acute Intermittent Hypoxia on Leg Function Following Spinal Cord Injury

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