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Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03433599
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : June 30, 2022
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Monica Perez, Shirley Ryan AbilityLab

Study Description
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Brief Summary:
Our goal is to enhance repeated exposure to acute intermittent hypoxia (rAIH)/training-induced aftereffects on upper and lower limb function recovery in humans with chronic spinal cord injury (SCI).

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Repeated exposure to acute Intermittent Hypoxia (rAIH) Other: Normal Room Air Other: Upper-limb Training by Research Staff Other: Lower-limb Training by Research Staff Not Applicable

Detailed Description:
The experiments in this study will test the following: Hypothesis 1.1(Experiment 1) that rAIH will enhance corticospinal excitability and upper and lower limb function in humans with incomplete SCI. Hypothesis 1.2 (Experiment 2) that enhancing the aftereffects of rAIH with exercise training will further enhance upper and lower limb motor function in humans with incomplete SCI. Measurements of corticospinal, cortical, and motoneuron excitability will be tested to further understand the mechanisms of this induced-plasticity. Persons with chronic (>6 months) spinal cord injury between the levels of C2 and T2. SCI subjects must possess either the ability to produce a visible precision grip force with one hand, and/or the ability to perform some small wrist flexion and extension. Additionally, subject must possess the ability to perform a small visible contraction with dorsiflexion and hip flexor muscles. Controls must be right handed due to potential differences in the organization of the brain in right handed and left handed individuals.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair
Actual Study Start Date : April 9, 2020
Estimated Primary Completion Date : December 28, 2024
Estimated Study Completion Date : December 28, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: rAIH + training by research staff
Participants will receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by research staff.
 Other: Repeated exposure to acute Intermittent Hypoxia (rAIH)
Participants will be fitted with a mask that will be placed over mouth and nose. Tubing will be attached to the front of the mask. The session will last approximately 30-45 minutes with 60-90 seconds of lower oxygen (tubing attached, 9-10% oxygen level), alternating with 60-90 sec of normal room air (no tubing attached).

Other: Upper-limb Training by Research Staff
Training sessions will last for approximately 30 minutes, with additional time for set up. During these sessions, participants will be asked to complete a variety of tasks related to general arm/hand movement, gross grasping, fine grasping, and hand cycle using an arm ergometer. The number of repetitions will be monitored and adjust the difficulty to ensure appropriate task difficulty.

Other: Lower-limb Training by Research Staff
Training sessions will last for approximately 30 minutes, with additional time for set up. During these sessions, participants will be asked to complete a variety of tasks related to general leg/foot movement, over-ground walking, treadmill walking, stair climbing training, leg cycling, standing frame, and NuStep. The number of repetitions will be monitored and adjust the difficulty to ensure appropriate task difficulty.
Sham Comparator: sham rAIH + training
Participants will sham receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by the research staff.
 Other: Normal Room Air
Participants will be fitted with a mask that will be placed over mouth and nose. Tubing will be attached to the front of the mask. The session will last approximately 30-45 minutes with 60-90 seconds of normal room air (with tubing attached to the mask) and 60-90 sec of normal room air (without the tubing attached to the mask).
Other Name: Sham repeated exposure to acute Intermittent Hypoxia (rAIH)

Other: Upper-limb Training by Research Staff
Training sessions will last for approximately 30 minutes, with additional time for set up. During these sessions, participants will be asked to complete a variety of tasks related to general arm/hand movement, gross grasping, fine grasping, and hand cycle using an arm ergometer. The number of repetitions will be monitored and adjust the difficulty to ensure appropriate task difficulty.

Other: Lower-limb Training by Research Staff
Training sessions will last for approximately 30 minutes, with additional time for set up. During these sessions, participants will be asked to complete a variety of tasks related to general leg/foot movement, over-ground walking, treadmill walking, stair climbing training, leg cycling, standing frame, and NuStep. The number of repetitions will be monitored and adjust the difficulty to ensure appropriate task difficulty.


Outcome Measures
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Primary Outcome Measures :
  1. Upper limb functional measurement [ Time Frame: 45 minutes to 1 hour ]
    The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) will be used to assess sensation, strength, and prehension.

  2. Lower limb functional measurement [ Time Frame: 5-10 minutes ]
    10-meter walk test will be used to assess walking speed

  3. MEP/CMEP recruitment curves using TMS [ Time Frame: 30 minutes to 1 hour ]
    Ten Transcranial magnetic stimuli (TMS) will be delivered to plot the mean peak-to-peak amplitude of the motor and cervicomedullary evoked potentials (MEPs and CMEPs, respectively) from the non-rectified response against the TMS intensity in each subject (MEP/CMEP recruitment curves).

  4. EMG and force voluntary output [ Time Frame: 30 minutes to 1 hour ]
    EMG surface electrodes will be placed over target muscles (deltoid, biceps brachii, first dorsal interosseous, abductor pollicis brevis, quadriceps femoris, tibialis anterior and/or soleus) to measure maximum voluntary contraction (MVC)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for SCI:

  1. Males and females between 18-85 years
  2. Chronic SCI (≥ 6 months post injury)
  3. SCI at or above L2
  4. ASIA A, B, C, or D, complete or incomplete
  5. Possess the following: The ability to produce a visible precision grip force with one hand, and/or the ability to perform some small wrist flexion and extension. The ability to perform a small visible contraction with dorsiflexion and hip flexor muscles.

Inclusion criteria for controls:

  1. Males and females between 18-85 years
  2. Right-handed (Only right-handed individuals will be accepted into this group because of the potential differences in the organization of the brain in right handed and left handed individuals)

Exclusion criteria for SCI and for controls:

  1. Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
  2. Any debilitating disease prior to the SCI that caused exercise intolerance
  3. Premorbid, ongoing major depression or psychosis, altered cognitive status
  4. History of head injury or stroke
  5. Metal plate in skull
  6. History of seizures
  7. Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressant
  8. Pregnant females
  9. Ongoing cord compression or a syrinx in the spinal cord or a spinal cord disease as spinal stenosis, spina bifida or herniated cervical disk.

AIH exclusion criteria (in addition to the above listed exclusion criteria)

  1. Resting heart rate ≥120 BPM
  2. Resting systolic blood pressure >180 mm Hg
  3. Resting diastolic Blood Pressure >100 mmHg
  4. Self-reported history of unstable angina or myocardial infarction within the previous month
  5. Resting SpO2 ≥ 95%
  6. Cardiopulmonary complications such as COPD
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): NCT03433599


Contacts
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Contact: Monica Perez, PhD 312-238-2886 mperez04@sralab.org

Locations
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United States, Illinois
Shirley Ryan AbilityLab Recruiting
Chicago, Illinois, United States, 60611
Contact: Monica Perez, PhD, PT    312-238-2886    mperez04@sralab.org   
Principal Investigator: Monica A Perez, PhD         
Sponsors and Collaborators
Shirley Ryan AbilityLab
U.S. Department of Education
Investigators
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Principal Investigator: Monica A Perez, PhD Shirley Ryan AbilityLab
More Information
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Responsible Party: Monica Perez, Scientific Chair Arms + Hands AbilityLab, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT03433599    
Other Study ID Numbers: STU00212000
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Monica Perez, Shirley Ryan AbilityLab:
Acute Intermittent Hypoxia
Transcranial Magnetic Stimulation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Hypoxia
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Signs and Symptoms, Respiratory