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Enrolling by Invitation

NCT Number: NCT06906536

Examining the Effect of Acute Intermittent Hypoxia on Serum Blood Proteins and Lower Limb Function

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.

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Key information

Conditions

INCOMPLETE SPINAL CORD INJURY (ASIA D) Able Bodied Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Andrew Tan

Boulder, Colorado, 80309, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acute Intermittent Hypoxia (AIH)

Other

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

Primary outcomes

  1. Change in Serum Blood Brain Derived Neurotrophic Factor

    Time frame: Baseline, Day 1, Day 3, and Day 4

    Serum blood brain derived neurotrophic factor (pg/mL) will be assessed using enzyme-linked immunosorbent assay. Blood will be sampled prior to AIH and within 1 hour following the 1st, 3rd, and 4th AIH exposure.

  2. Change in Serum Serotonin

    Time frame: Baseline, Day 1, Day 3, and Day 4

    Serum serotonin (ng/mL) be assessed using enzyme-linked immunosorbent assay. Blood will be sampled prior to AIH and within 1 hour following the 1st, 3rd, and 4th AIH exposure.

  3. Change in the Transcranial Magnetic Stimulation Recruitment Curve Slope

    Time frame: Baseline and Day 4

    The mean motor evoked potential response will be plotted against the corresponding stimulation intensity (% resting motor threshold) to produce a stimulus-response curve at 20% and 40% of maximum. We will measure TMS before the start of 4 consecutive days of AIH exposure. We will measure TMS within 24 hours of the final AIH exposure.

  4. Change in Force Steadiness

    Time frame: Baseline and Day 4

    The coefficient of variation of force will be calculated in both plantarflexion and dorsiflexion at 20% and 40% of maximum. We will measure coefficient of variation of force before the start of 4 consecutive days of AIH exposure. We will measure coefficient of variation of force within 24 hours of the final AIH exposure.

  5. Change in Central Activation Ratio

    Time frame: Baseline and Day 4

    We will measure the central activation ratio using supramaximal electrical stimulus over a peripheral nerve during maximum voluntary activation. We will measure the central activation ratio before the start of 4 consecutive days of AIH exposure. We will measure the central activation ratio within 24 hours of the final AIH exposure.

  6. Change in hemoglobin mass

    Time frame: Baseline and Day 4

    Using the optimized carbon monoxide rebreathing procedure we will evaluate hemoglobin concentration, carboxyhemoglobin, and hematocrit to calculate total hemoglobin mass, blood volume, and plasma volume. The optimized carbon monoxide rebreathing procedure will be done prior to the first hypoxia exposure and following the 4th hypoxia exposure.

  7. Change in Serum Erythropoetin

    Time frame: Baseline, Day 1, Day 3, and Day 4

    Serum erythropoetin (mU/mL) will be assessed using enzyme-linked immunosorbent assay. Blood will be sampled prior to AIH and within 1 hour following the 1st, 3rd, and 4th AIH exposure.

Secondary outcomes

  1. Axial damage ratio

    Time frame: Baseline

    Using MRI, we will quantify the axial damage ratio. Prior to participation in the study we will obtain an MRI for quantification of axial damage ratio

  2. 6-Minute Walk Test

    Time frame: Baseline and Day 4

    We will assess the distance walked in 6-minutes. The 6-minute walk test will be completed prior to the first exposure to hypoxia and following the 4th exposure of hypoxia.

  3. 10-Meter Walk Test

    Time frame: Baseline and Day 4

    We will assess how long it takes subjects to walk 10 meters. The 10-Meter walk test will be done prior to the first hypoxia exposure, and following the 4th hypoxia exposure.

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Colorado, Denver

Registry information

Official study title

Examining the Effect of Acute Intermittent Hypoxia on Serum Blood Proteins, Corticospinal Excitability, and Force Control in Persons With Incomplete Spinal Cord Injury

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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