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NCT06906536

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

Enrolling by Invitation
NAAges 18–75InterventionalTreatment
University of Colorado, Boulder
~100 participants
Updated 2025-04-04 on ClinicalTrials.gov
What's tested:Acute Intermittent Hypoxia (AIH)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Serum Blood Brain Derived Neurotrophic Factor
Measured over Baseline, Day 1, Day 3, and Day 4
+6 more outcomes measured

Conditions

INCOMPLETE SPINAL CORD INJURY (ASIA D)
Able Bodied

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
Colorado1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Serum Blood Brain Derived Neurotrophic FactorBaseline, 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.

  • Change in Serum SerotoninBaseline, 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.

  • Change in the Transcranial Magnetic Stimulation Recruitment Curve SlopeBaseline 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.

  • Change in Force SteadinessBaseline 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.

  • Change in Central Activation RatioBaseline 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.

  • Change in hemoglobin massBaseline 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.

  • Change in Serum ErythropoetinBaseline, 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.