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Intermittent Hypoxia and Upper Extremity EMG Recordings in Individuals With 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05513911
Recruitment Status : Completed
First Posted : August 24, 2022
Last Update Posted : August 24, 2022
Sponsor:
Information provided by (Responsible Party):
Milap Sandhu, Shirley Ryan AbilityLab

Study Description
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Brief Summary:
In this current study, the examiners examine some of the mechanisms of how Acute Intermittent Hypoxia (AIH) effects the upper extremity of survivors of spinal cord injury. This is accomplished both with the use of a load cell to determine elbow strength changes and high density grid electromyography (EMG) to record bicep muscle activations before and after bouts of AIH

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Acute Intermittent Hypoxia Not Applicable

Detailed Description:
It has been shown previously that there is an increase in strength in survivors of spinal cord injury after brief bouts of Acute Intermittent Hypoxia. In this study, participants are fitted with a high density EMG electrode on the biceps brachii, and attached to a load cell at the wrist, they are asked to flex and extend their elbow at various levels of intensity. This is performed before and after the 30 minute session of AIH. The investigators hope to identify specific types of motor units of the upper extremity of survivors of spinal cord injury after AIH to help further our understanding of what mechanisms may be causing the known increase in muscle strength post AIH
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Every participant in this study will receive the intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intermittent Hypoxia and Upper Limb Training in Individuals With Spinal Cord Injury
Actual Study Start Date : February 3, 2016
Actual Primary Completion Date : November 8, 2016
Actual Study Completion Date : March 25, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Acute intermittent Hypoxia Therapy
This group will receive the acute intermittent hypoxia therapy (9% O2) for 30 minutes. Before and after the intervention the participant will perform flexion of the elbow at various levels of intensity
 Other: Acute Intermittent Hypoxia
Acute Intermittent Hypoxia is administered in 30-60 second bouts of 9% O2 concentration, followed by 60-90 seconds of normoxic air concentrations (21% O2, room air). This procedure is repeated 15 times for a 30 minute session
Other Name: AIH


Outcome Measures
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Primary Outcome Measures :
  1. Maximal Elbow Strength [Newtons] [ Time Frame: 30 minutes Post intervention ]
    Recordings of the elbow joint torque are taken while the participant is asked to flex and extend the elbow voluntarily at a maximum level of intensity


Secondary Outcome Measures :
  1. Biceps Brachii Muscle activation [μv] [ Time Frame: 30 minutes post intervention ]
    Peak electromyographic activation of the biceps brachii muscle during maximum voluntary flexion and extension tasks


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of Spinal Cord Injury from C3-T4
  • Non-progressive spinal cord injury
  • More than 6 months since initial Spinal Cord injury
  • Ability to understand and willingness to sign written informed consent

Exclusion Criteria:

  • Presence of any of the following medical conditions: Congestive heart failure, arrhythmia, uncontrolled high blood pressure, uncontrolled diabetes mellitus, COPD/emphysema and severe asthma
  • Persons with known coronary artery disease, a history of myocardial infarction, or known carotid or intracerebral artery stenosis
  • Medical clearance will be required if participant is taking any other investigational agents
  • Women who are pregnant or nursing
  • Individuals with tracheostomy
  • Cannot pursue other research studies which may interfere
  • Unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Prisoners
Contacts and Locations
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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): NCT05513911


Locations
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United States, Illinois
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Shirley Ryan AbilityLab
Investigators
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Principal Investigator: William Z Rymer, MD, PhD Shirley Ryan AbilityLab
Principal Investigator: Milap Sandhu, PhD Shirley Ryan AbilityLab
More Information
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Responsible Party: Milap Sandhu, Principal Investigator, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT05513911    
Other Study ID Numbers: STU00201602
First Posted: August 24, 2022    Key Record Dates
Last Update Posted: August 24, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Overall participant Data will be reported in publications

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Milap Sandhu, Shirley Ryan AbilityLab:
Acute Intermittent Hypoxia
Motor Unit
Upper Extremity
Additional relevant MeSH terms:
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Spinal Cord Injuries
Hypoxia
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Signs and Symptoms, Respiratory