Intermittent Hypoxia Elicits Prolonged Restoration of Motor Function in Human SCI

This study has been completed.
Sponsor:
Collaborators:
Rehabilitation Institute of Chicago
Shepherd Center, Atlanta GA
Northwestern University
University of Wisconsin, Madison
University of Saskatchewan
Information provided by (Responsible Party):
Randy D. Trumbower, Emory University
ClinicalTrials.gov Identifier:
NCT01272349
First received: January 4, 2011
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

The goal of the study is to determine whether repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) will improve limb function after spinal cord injury. This idea stems from animal studies on respiration, in which investigators have shown that mild intermittent hypoxia improves breathing in spinally injured rats. These studies have shown that intermittent hypoxia induces spinal plasticity, strengthening neural connections and motor neuron function within the spinal cord. Exposure to mild intermittent hypoxia triggers a cascade of events, including increased production of key proteins and increased sensitivity of spinal cord circuitry necessary for improved breathing.

The ultimate goal of this research is to assess the potential of mild intermittent hypoxia as a therapeutic approach to stimulate recovery of limb function in human patients.


Condition Intervention Phase
Spinal Cord Injury
Other: Acute intermittent hypoxia
Other: Room air
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intermittent Hypoxia Elicits Prolonged Restoration of Motor Function in Human SCI

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Walking performance [ Time Frame: 1 Week ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: December 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low oxygen Other: Acute intermittent hypoxia
30 minutes of intermittent breathing low oxygen followed by walking on a body-weight support treadmill
Other Name: breathing low oxygen
Sham Comparator: Room Air Other: Room air
30 minutes of breathing room air followed by walking on a body-weight support treadmill
Other Name: breathing room air

Detailed Description:

: The goal of the study is to determine whether repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) will improve limb function after spinal cord injury. This idea stems from animal studies on respiration, in which investigators have shown that mild intermittent hypoxia improves breathing in spinally injured rats. These studies have shown that intermittent hypoxia induces spinal plasticity, strengthening neural connections and motor neuron function within the spinal cord. Exposure to mild intermittent hypoxia triggers a cascade of events, including increased production of key proteins and increased sensitivity of spinal cord circuitry necessary for improved breathing.

The investigators initially hypothesize that daily exposure to intermittent hypoxia for 7 consecutive days will improve limb function in rats and in humans with chronic spinal injuries. First, the investigators will compare limb function in spinally-injured rats which receive mild intermittent hypoxia treatment with rats that did not. The investigators will measure grip strength and locomotor abilities in both groups before treatment and for several months after treatment. The investigators will also examine the spinal cords of these rats to look for the key proteins, which are indicators of spinal plasticity. The investigators will use this information to guide the treatment protocols when the investigators compare limb function in spinal-injured persons with and without intermittent hypoxia treatment.

The second hypothesis is that combining intermittent hypoxia with locomotor training will further improve limb function after spinal injury. To test this idea, the investigators will compare limb function in spinally-injured rats which have received combined intermittent hypoxia and treadmill training with rats which only received intermittent hypoxia or locomotor training alone. The investigators will examine key proteins in the spinal cords of these rats to determine whether the combination of hypoxia and training further alters these indicators of plasticity. The investigators will also compare limb function in spinally-injured humans who receive both intermittent hypoxia and locomotor treadmill training with those who receive either treatment alone.

The ultimate goal of this research is to assess the potential of mild intermittent hypoxia as a therapeutic approach to stimulate recovery of limb function in human patients.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • medical clearance to participate
  • lesion below C5 and above T12 with non-progressive etiology
  • classified as motor-incomplete
  • injury greater than 12 months
  • ambulatory with minimal assistance

Exclusion Criteria:

  • Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of cardiac or pulmonary complications)
  • Pregnant women because of the unknown affects of AIH on pregnant women and fetus
  • History of seizures, brain injury, and/or epilepsy
  • Diagnosed with obstructive sleep apnea
  • Undergoing concurrent physical therapy
  • Any contraindications to EMG testing procedures (skin sensitivity)
  • Any contraindications to passive movement of the limbs (e.g., joint immobility, hemodynamic instability)
  • Score of < 24 on Mini-Mental Exam
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272349

Locations
United States, Georgia
Shepherd Center
Atlanta, Georgia, United States, 30309
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Emory University
Rehabilitation Institute of Chicago
Shepherd Center, Atlanta GA
Northwestern University
University of Wisconsin, Madison
University of Saskatchewan
Investigators
Principal Investigator: Randy D Trumbower, PT, PhD Emory University
  More Information

Additional Information:
No publications provided by Emory University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Randy D. Trumbower, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01272349     History of Changes
Other Study ID Numbers: IRB00035986a, W81XWH-10-1-0832
Study First Received: January 4, 2011
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
spinal cord injury
walking
low oxygen
air
strength

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 21, 2014