NCT05341466

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 27, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2025

Completed
3 months until next milestone

Results Posted

Study results publicly available

May 14, 2025

Completed
Last Updated

May 14, 2025

Status Verified

April 1, 2025

Enrollment Period

2.7 years

First QC Date

April 11, 2022

Results QC Date

March 14, 2025

Last Update Submit

April 29, 2025

Conditions

Keywords

Spinal Cord InjuryMotor AdaptationAcute Intermittent Hypoxia

Outcome Measures

Primary Outcomes (4)

  • Change in Corticospinal Excitability

    Transcranial magnetic stimulation (TMS) can be applied over the primary motor cortex to examine changes in corticospinal excitability. The downstream muscle activation can be recorded with surface EMG as a motor-evoked potential (MEP). The peak-to-peak MEP amplitude (mV) is as an index of corticospinal excitability. A randomized sequence of TMS intensities can be applied over the primary motor cortex, ranging from 90-140% of the participants' resting motor threshold (RMT). The mean MEP amplitude will be plotted against the corresponding stimulation intensity to produce the recruitment curve. The area under the recruitment curve is an additional index of corticospinal excitability (mV/% RMT).

    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.

  • Step Length Asymmetry

    Step length asymmetry will be quantified as the ratio of the normalized difference in step lengths between the fast and slow legs during split-belt motor adaptation: (Fast leg - Slow leg step length) / (Fast leg + Slow leg step length).

    We will compare asymmetry 15 minutes after the final AIH treatment to asymmetry following no treatment (control group).

  • Step Time Asymmetry

    Step time asymmetry will be quantified as the ratio of the normalized difference in step times between the fast and slow legs during split-belt motor adaptation: (Fast leg - Slow leg step time) / (Fast leg + Slow leg step time).

    We will compare asymmetry 15 minutes after the final AIH treatment to asymmetry following no treatment (control group).

  • Net Metabolic Power

    Using expired gas analyses, we will calculate net metabolic power by inputting steady-state values for V̇O₂ and V̇CO₂ into standard regression equations (W), subtracting resting values, and normalizing the result to each participant's body weight (kg).

    We will compare net metabolic power 15 minutes after the final AIH treatment to asymmetry following no treatment (control group).

Study Arms (3)

Repetitive Acute Intermittent Hypoxia

EXPERIMENTAL

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

Other: Acute Intermittent Hypoxia

SHAM Acute Intermittent Hypoxia

SHAM COMPARATOR

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

Other: SHAM Acute Intermittent Hypoxia

Control

NO INTERVENTION

The control group received no AIH exposure.

Interventions

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

Repetitive 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

SHAM Acute Intermittent Hypoxia

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

University of Colorado

Boulder, Colorado, 80309, United States

Location

Related Publications (2)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Results Point of Contact

Title
Andrew Q. Tan
Organization
University of Colorado, Boulder

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 11, 2022

First Posted

April 22, 2022

Study Start

May 27, 2022

Primary Completion

January 31, 2025

Study Completion

February 24, 2025

Last Updated

May 14, 2025

Results First Posted

May 14, 2025

Record last verified: 2025-04

Locations