Clinical trial NCT05341466: The Effect of Acute Intermittent Hypoxia on Motor Learning
Official title: Examining the Relationship Between Changes in Corticospinal Excitability and Motor Learning After Acute Intermittent Hypoxia in Able-bodied Individuals for Subsequent Study in Individuals With Incomplete Spinal Cord Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incomplete Spinal Cord Injury
Keywords: Spinal Cord Injury
Motor Adaptation
Acute Intermittent Hypoxia
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
name: Medical University of South Carolina
First posted: 2022-04-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study design is twofold. The first study examines the effects of AIH on motor learning using an AIH group and a control group (total N = 30). The second part of this study examines corticospinal indices of motor learning using an AIH group and a SHAM group (i.e., blinded normoxia; total N = 26).
Primary purpose: TREATMENT

Brief summary: The goal of this study is to examine the effect of repetitive acute intermittent hypoxia on motor learning abilities in able-bodied individuals for subsequent study in individuals with incomplete spinal cord injury.


Eligibility criteria: Inclusion Criteria:

* 18 to 70 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 disorders
* Metal implants in the head, or pacemaker.

Primary outcomes:
measure: Change in Corticospinal Excitability
timeFrame: We will measure TMS before the start of 5 consecutive days of AIH or SHAM treatment. We will measure TMS within 24 hours of the final treatment.
measure: Step Length Asymmetry
timeFrame: We will compare asymmetry 15 minutes after the final AIH treatment to asymmetry following no treatment (control group).
measure: Step Time Asymmetry
timeFrame: We will compare asymmetry 15 minutes after the final AIH treatment to asymmetry following no treatment (control group).
measure: Net Metabolic Power
timeFrame: We will compare net metabolic power 15 minutes after the final AIH treatment to asymmetry following no treatment (control group).
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado, Anschutz Medical Campus
state: Colorado
city: Boulder
country: United States
facility: University of Colorado
state: Colorado
Study officials:
References:
citation: Bogard AT, Hembree TG, Pollet AK, Smith AC, Ryder SC, Marzloff GE, Tan AQ. Intermittent hypoxia-induced enhancements in corticospinal excitability predict gains in motor learning and metabolic efficiency. Sci Rep. 2025 Feb 24;15(1):6614. doi: 10.1038/s41598-025-90890-8.
citation: Bogard AT, Hemmerle MR, Smith AC, Tan AQ. Enhanced motor learning and motor savings after acute intermittent hypoxia are associated with a reduction in metabolic cost. J Physiol. 2024 Nov;602(21):5879-5899. doi: 10.1113/JP285425. Epub 2023 Nov 20.