Status:
COMPLETED
Measuring the Neurological Benefits of Intermittent Hypoxia Therapy With MRI
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Shirley Ryan AbilityLab
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This study uses Magnetic Resonance Imaging to image the brain and spinal cord before and after an Intermittent Hypoxia intervention. Acquiring these scans in patients with chronic cervical spinal cord...
Detailed Description
Acute intermittent hypoxia (AIH) is an emerging, safe technique for facilitating neural plasticity in individuals with chronic spinal cord injury (SCI), demonstrating significant transient improvement...
Eligibility Criteria
Inclusion
- All participants must meet the following inclusion criteria:
- Between the ages of 18-60 years
- Safe to be scanned using MRI
- Able to communicate in English
- Ability to sign informed consent
- In addition, the participants recruited with SCI must meet the following criteria:
- History of a traumatic spinal cord injury, inclusive of levels C2-T1
- At least 6 months since onset of spinal cord injury
- Cause of the spinal cord injury was non-progressive
- Ability to complete and comply with information within the informed consent
- Ability to close and open at least one hand without assistance
Exclusion
- MRI contraindications as indicated on MRI safety screening form
- Subjects with pacemakers, cochlear (in the ear) implants, or aneurysm clips or subjects who have worked with metal
- Women who are currently pregnant, nursing, or planning on becoming pregnant
- Individuals with severe claustrophobia
- Subjects unwilling or unable to give written informed consent in English
- Prisoners
- Frequent smokers (greater than 5 cigarettes per day)
- Blood pressure greater than 160/110 or less than 85/55.
- Individuals who report headaches, feeling dizzy or light-headed, or have heart palpitations on the day of the study.
- Diagnosis of any of the following comorbid conditions: congestive heart failure, cardiac arrhythmias, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, emphysema, severe asthma, previous myocardial infraction or known carotid/intracerebral artery stenosis, presence of active deep venous thrombosis, or cancer.
- Individuals who utilize mechanical ventilation or have a tracheostomy
- Individuals who utilize an intrathecal baclofen pump
- Orthopedic injury affecting upper extremities
- Currently participating in any other hypoxia related study.
Key Trial Info
Start Date :
May 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2023
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05183113
Start Date
May 20 2019
End Date
July 30 2023
Last Update
September 28 2023
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611