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Study Effects of Intermittent Hypoxia on Restoring Hand Function Following SCI

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Emory University
Sponsor:
Collaborators:
University of Saskatchewan
University of Wisconsin, Madison
Information provided by (Responsible Party):
Randy D. Trumbower, Emory University
ClinicalTrials.gov Identifier:
NCT01272336
First received: January 4, 2011
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

The goal of the study is to examine the effects of repeated breathing episodes of mild intermittent hypoxia (reduced oxygen) training on hand strength and grasping ability following cervical spinal injury, and to determine whether these changes result in improved hand function. If so, such changes may indicate hypoxia-induced spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences), which could result in improvements in hand use for persons with spinal cord injury (SCI).


Condition Intervention Phase
Spinal Cord Injury
Device: Acute intermittent hypoxia
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intermittent Hypoxia Promotes Restoration of Hand Function Following SCI

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Hand grasp [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Grip strength [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Room Air Device: Acute intermittent hypoxia
Repeat bouts of breathing mild levels of low oxygen
Other Name: breathing room air

Detailed Description:

The goal of the study is to examine the effects of repeated breathing episodes of mild intermittent hypoxia (reduced oxygen) training on hand strength and grasping ability following cervical spinal injury, and to determine whether these changes result in improved hand function. If so, such changes may indicate hypoxia-induced spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences), which could result in improvements in hand use for persons with spinal cord injury (SCI).

This idea stems from animal studies on respiration, in which investigators have shown that intermittent hypoxia induces spinal plasticity, strengthening neural connections within the spinal cord by a mechanism known as respiratory long-term facilitation. Exposure to mild hypoxia triggers oxygen sensors in the nervous system resulting in a cascade of events, including increased production of key proteins and, increased sensitivity of spinal cord circuitry necessary for improved respiration.

Because previous work using animal models has shown that similar events occur along non-respiratory pathways, the investigators propose to investigate whether a comparable dosing scheme of daily, mild intermittent hypoxia can positively affect upper limb function in persons with cervical SCI.

First, the investigators hypothesize that daily exposure of intermittent hypoxia training (7 consecutive days) will result in a sustained improvement in rat forelimb function that is dose-dependent. To test this hypothesis, the investigators will quantify the effects of variations in the number of intermittent hypoxia episodes on forelimb function in cervical spinal injured rats.

Second, the investigators hypothesize that daily exposure of intermittent hypoxia training will improve hand function in persons with cervical spinal injury. To test this hypothesis, the investigators will quantify the effect of mild intermittent hypoxia exposure, using a protocol derived from the animal model, on volitional grip strength and grasp function in persons with cervical SCI.

The effects of mild intermittent hypoxia, known to increase spinal motor activity, will be assessed as a possible therapeutic intervention to promote functionally useful hand recovery. Results from this study will be valuable for identifying novel strategies to control spinal neuron excitability and for improving motor function in persons with spinal cord injury.

  Eligibility

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

Inclusion Criteria:

  • age 18 and 65 years
  • medical clearance to participate
  • lesion below the 5th cervical spinous process (C5) and above the first thoracic spinous process (T1) with non-progressive etiology
  • classified as motor-incomplete injury greater than 12 months
  • independent breathing

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 acute intermittent hypoxia on pregnant women and fetus
  • Concomitant acquired brain injury
  • 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
  • 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: NCT01272336

Contacts
Contact: Randy Trumbower 404-727-5985 randy.trumbower@emory.edu
Contact: Heather Hayes 404-727-5985 hbhayes@emory.edu

Locations
United States, Georgia
Emory Center for Rehabilitation Medicine Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Randy D Trumbower, PT, PhD         
Sponsors and Collaborators
Emory University
University of Saskatchewan
University of Wisconsin, Madison
Investigators
Principal Investigator: Randy D Trumbower, PT, PhD Emory University
  More Information

No publications provided

Responsible Party: Randy D. Trumbower, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01272336     History of Changes
Other Study ID Numbers: IRB00035986, 163907
Study First Received: January 4, 2011
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
spinal cord injury, low oxygen, strength, motor control

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 November 25, 2014