Status:
UNKNOWN
Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair
Lead Sponsor:
Shirley Ryan AbilityLab
Collaborating Sponsors:
U.S. Department of Education
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-85 years
Phase:
NA
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).
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. H...
Eligibility Criteria
Inclusion
- Inclusion criteria for SCI:
- Males and females between 18-85 years
- Chronic SCI (≥ 6 months post injury)
- SCI at or above L2
- ASIA A, B, C, or D, complete or incomplete
- 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:
- Males and females between 18-85 years
- 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:
- Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
- Any debilitating disease prior to the SCI that caused exercise intolerance
- Premorbid, ongoing major depression or psychosis, altered cognitive status
- History of head injury or stroke
- Metal plate in skull
- History of seizures
- Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressant
- Pregnant females
- 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)
- Resting heart rate ≥120 BPM
- Resting systolic blood pressure \>180 mm Hg
- Resting diastolic Blood Pressure \>100 mmHg
- Self-reported history of unstable angina or myocardial infarction within the previous month
- Resting SpO2 ≥ 95%
- Cardiopulmonary complications such as COPD
Exclusion
Key Trial Info
Start Date :
April 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 28 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03433599
Start Date
April 9 2020
End Date
December 28 2025
Last Update
June 30 2022
Active Locations (1)
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1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611