Status:
ENROLLING_BY_INVITATION
Examining the Effect of Acute Intermittent Hypoxia on Serum Blood Proteins and Lower Limb Function
Lead Sponsor:
University of Colorado, Boulder
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Colorado, Denver
Conditions:
INCOMPLETE SPINAL CORD INJURY (ASIA D)
Able Bodied
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The goal of this study is to clarify mechanisms of acute intermittent hypoxia and to examine the effect on lower limb function in persons with chronic, incomplete spinal cord injury.
Detailed Description
The goal of this study is to clarify mechanisms of acute intermittent hypoxia by examining changes in blood biomarkers, neural excitability, and hemoglobin mass. We also aim to clarify how these chang...
Eligibility Criteria
Inclusion
- 18 to 75 years old (the latter to reduce likelihood of heart disease)
- Medically stable with medical clearance from physician to participate
- Motor-incomplete spinal cord injuries at or below C2 and at or above L5
- AIS A-D at initial screen, or other non-traumatic spinal cord injury disorders (e.g. multiple sclerosis, ALS, tumors, acute transverse myelitis, etc.)
- More than 1 year since iSCI to minimize confounds of spontaneous neurological recovery
- Ability to advance one step overground with or without assistive devices;
Exclusion
- Severe concurrent illness or pain
- Recurrent autonomic dysreflexia
- History of cardiovascular/pulmonary complications
- Concurrent physical therapy
- Pregnant at time of enrollment or planning to become pregnant
- Untreated painful musculoskeletal dysfunction, fracture or pressure sore
- History of seizures or epilepsy
- Recurring headaches
- Concussion within the last six months
- Depression or manic disorder
- Metal implants in the head, or pacemaker
- Aversion to needles
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06906536
Start Date
March 1 2024
End Date
August 1 2026
Last Update
April 4 2025
Active Locations (1)
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1
Andrew Tan
Boulder, Colorado, United States, 80309