Clinical trial NCT06906536: Examining the Effect of Acute Intermittent Hypoxia on Serum Blood Proteins and Lower Limb Function
Official title: Examining the Effect of Acute Intermittent Hypoxia on Serum Blood Proteins, Corticospinal Excitability, and Force Control in Persons With Incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: INCOMPLETE SPINAL CORD INJURY (ASIA D)
Able Bodied
Keywords: Acute Intermittent Hypoxia
Spinal cord injury
Force steadiness
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Colorado, Denver
First posted: 2025-04-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 changes relate to changes in lower limb function in persons with chronic, incomplete spinal cord injury by measuring force steadiness and voluntary muscle activation.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in Serum Blood Brain Derived Neurotrophic Factor
timeFrame: Baseline, Day 1, Day 3, and Day 4
measure: Change in Serum Serotonin
timeFrame: Baseline, Day 1, Day 3, and Day 4
measure: Change in the Transcranial Magnetic Stimulation Recruitment Curve Slope
timeFrame: Baseline and Day 4
measure: Change in Force Steadiness
timeFrame: Baseline and Day 4
measure: Change in Central Activation Ratio
timeFrame: Baseline and Day 4
measure: Change in hemoglobin mass
timeFrame: Baseline and Day 4
measure: Change in Serum Erythropoetin
timeFrame: Baseline, Day 1, Day 3, and Day 4
Secondary outcomes:
measure: Axial damage ratio
timeFrame: Baseline
measure: 6-Minute Walk Test
timeFrame: Baseline and Day 4
measure: 10-Meter Walk Test
timeFrame: Baseline and Day 4
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Andrew Tan
state: Colorado
Study officials:
References: