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The Effect of Acute Intermittent Hypoxia on Motor Learning

Primary Purpose

Incomplete Spinal Cord Injury

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acute Intermittent Hypoxia
SHAM Acute Intermittent Hypoxia
Sponsored by
University of Colorado, Boulder
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incomplete Spinal Cord Injury focused on measuring Acuter Intermittent Hypoxia, Spinal Cord Injury, Motor Adaptation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Colorado, Anschutz Medical Campus
  • University of Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Repetitive Acute Intermittent Hypoxia

SHAM Acute Intermittent Hypoxia

Arm Description

5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals

5 consecutive days of 15, 1.5 min episodes at 21% O2 (SHAM AIH) alternating with 21% O2 at 1 min intervals

Outcomes

Primary Outcome Measures

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
Change in Step Length Asymmetry
Step length asymmetry will be quantified as the ratio of normalized difference in step lengths of each leg.
Change in Step Time Asymmetry
Step time asymmetry will be quantified as the ratio of normalized difference in step times of each leg
Change in Metabolic Power
Using expired gas analyses, the measured rates of V̇o2 and V̇co2, will be converted to metabolic power and normalized to each participant's body weight

Secondary Outcome Measures

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.
Change in Leg Kinematics
The relative ankle, knee, and hip joint angle excursions throughout the gait cycle will be quantified during walking assessments.

Full Information

First Posted
April 11, 2022
Last Updated
June 13, 2022
Sponsor
University of Colorado, Boulder
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Colorado, Denver, Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT05341466
Brief Title
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 Persons With Incomplete Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 27, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Colorado, Boulder
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Colorado, Denver, Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incomplete Spinal Cord Injury
Keywords
Acuter Intermittent Hypoxia, Spinal Cord Injury, Motor Adaptation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Repetitive Acute Intermittent Hypoxia
Arm Type
Experimental
Arm Description
5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals
Arm Title
SHAM Acute Intermittent Hypoxia
Arm Type
Sham Comparator
Arm Description
5 consecutive days of 15, 1.5 min episodes at 21% O2 (SHAM AIH) alternating with 21% O2 at 1 min intervals
Intervention Type
Other
Intervention Name(s)
Acute Intermittent Hypoxia
Intervention Description
5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals
Intervention Type
Other
Intervention Name(s)
SHAM Acute Intermittent Hypoxia
Intervention Description
5 consecutive days of 15, 1.5 min episodes at 21% O2 (SHAM AIH) alternating with 21% O2 at 1 min intervals
Primary Outcome Measure Information:
Title
Change in the Transcranial Magnetic Stimulation Recruitment Curve Slope
Description
The mean motor evoked potential response will be plotted against the corresponding stimulation intensity (% resting motor threshold) to produce a stimulus-response curve
Time Frame
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.
Title
Change in Step Length Asymmetry
Description
Step length asymmetry will be quantified as the ratio of normalized difference in step lengths of each leg.
Time Frame
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.
Title
Change in Step Time Asymmetry
Description
Step time asymmetry will be quantified as the ratio of normalized difference in step times of each leg
Time Frame
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.
Title
Change in Metabolic Power
Description
Using expired gas analyses, the measured rates of V̇o2 and V̇co2, will be converted to metabolic power and normalized to each participant's body weight
Time Frame
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 Outcome Measure Information:
Title
Change Muscle Surface Electromyography
Description
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.
Time Frame
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.
Title
Change in Leg Kinematics
Description
The relative ankle, knee, and hip joint angle excursions throughout the gait cycle will be quantified during walking assessments.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of Colorado, Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309
Country
United States

12. IPD Sharing Statement

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The Effect of Acute Intermittent Hypoxia on Motor Learning

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