NCT01272349

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2010

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

2.9 years

First QC Date

January 4, 2011

Last Update Submit

November 20, 2013

Conditions

Spinal Cord Injury

Keywords

spinal cord injurywalkinglow oxygenairstrength

Outcome Measures

Primary Outcomes (1)

  • Walking performance

    1 Week

Study Arms (2)

Low oxygen

EXPERIMENTAL
Other: Acute intermittent hypoxia

Room Air

SHAM COMPARATOR
Other: Room air

Interventions

Acute intermittent hypoxiaOTHER

30 minutes of intermittent breathing low oxygen followed by walking on a body-weight support treadmill

Also known as: breathing low oxygen
Low oxygen
Room airOTHER

30 minutes of breathing room air followed by walking on a body-weight support treadmill

Also known as: breathing room air
Room Air

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • 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.

    PMID: 24285617DERIVED

Related Links

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Randy D Trumbower, PT, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 4, 2011

First Posted

January 7, 2011

Study Start

December 1, 2010

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations

US(2)