Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair
NCT ID: NCT03433599
Last Updated: 2022-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2020-04-09
2025-12-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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rAIH + training by research staff
Participants will receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by research staff.
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).
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.
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 rAIH + training
Participants will sham receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by the research staff.
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).
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.
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.
Interventions
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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).
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).
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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
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.
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
18 Years
85 Years
ALL
Yes
Sponsors
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U.S. Department of Education
FED
Shirley Ryan AbilityLab
OTHER
Responsible Party
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Monica Perez
Scientific Chair Arms + Hands AbilityLab
Principal Investigators
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Monica A Perez, PhD
Role: PRINCIPAL_INVESTIGATOR
Shirley Ryan AbilityLab
Locations
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Shirley Ryan AbilityLab
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STU00212000
Identifier Type: -
Identifier Source: org_study_id
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