The Effect of Acute Intermittent Hypoxia on Motor Learning

Incomplete Spinal Cord Injury Clinical Trial

Official title:

Examining the Relationship Between Changes in Corticospinal Excitability and Motor Learning After Acute Intermittent Hypoxia in Persons With Incomplete Spinal Cord Injury

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05341466
• Other study ID #: 21-3980
• Secondary ID: P2CHD086844
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 27, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: February 2024
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this pilot study is to examine the effect of repetitive acute intermittent hypoxia on motor learning in persons with chronic, incomplete spinal cord injury.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: May 31, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypoxia
• Incomplete Spinal Cord Injury
• Spinal Cord Injuries

Intervention

Other:
• Acute Intermittent Hypoxia
5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals
• SHAM Acute Intermittent Hypoxia
5 consecutive days of 15, 1.5 min episodes at 21% O2 (SHAM AIH) alternating with 21% O2 at 1 min intervals

Locations

Country	Name	City	State
United States	University of Colorado, Anschutz Medical Campus	Aurora	Colorado
United States	University of Colorado	Boulder	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Boulder	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Medical University of South Carolina, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Transcranial Magnetic Stimulation Recruitment Curve Slope	The mean motor evoked potential response will be plotted against the corresponding stimulation intensity (% resting motor threshold) to produce a stimulus-response curve	We will measure TMS before the start of 5 consecutive days of AIH treatment. We will measure TMS within 24 hours of the final AIH treatment.
Primary	Change in Step Length Asymmetry	Step length asymmetry will be quantified as the ratio of normalized difference in step lengths of each leg.	We will measure asymmetry before the start of 5 consecutive days of AIH treatment as baseline. We will measure asymmetry within 24 hours after the final AIH treatment.
Primary	Change in Step Time Asymmetry	Step time asymmetry will be quantified as the ratio of normalized difference in step times of each leg	We will measure asymmetry before the start of 5 consecutive days of AIH treatment as baseline. We will measure asymmetry within 24 hours after the final AIH treatment.
Primary	Change in Metabolic Power	Using expired gas analyses, the measured rates of V?o2 and V?co2, will be converted to metabolic power and normalized to each participant's body weight	We will measure metabolic power before the start of 5 consecutive days of AIH treatment as baseline. We will measure metabolic power within 24 hours after the final AIH treatment.
Secondary	Change Muscle Surface Electromyography	Muscle activation will be recording using surface EMG, and quantified as the activation amplitude and activation timing of the leg muscles during walking assessments. EMG amplitude will be normalized to maximum contraction during walking and activation will be normalized to the gait cycle. We will record EMG's of the muscles that contribute to ankle and knee joint torque production.	We will measure EMG during a baseline walking assessment before the start of 5 consecutive days of AIH treatment. We will measure EMG during a post walking assesment within 24 hours after the final AIH treatment.
Secondary	Change in Leg Kinematics	The relative ankle, knee, and hip joint angle excursions throughout the gait cycle will be quantified during walking assessments.	We will measure kinematics during a baseline walking assessment before the start of 5 consecutive days of AIH treatment. We will measure kinematics during a post walking assesment within 24 hours after the final AIH treatment.