Examining the Effect of Acute Intermittent Hypoxia on Serum Blood Proteins and Lower Limb Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acute Intermittent Hypoxia (AIH).
- Who it may be relevant to
- Registry conditions: INCOMPLETE SPINAL CORD INJURY (ASIA D), Able Bodied. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Examining the Effect of Acute Intermittent Hypoxia on Serum Blood Proteins, Corticospinal Excitability, and Force Control in Persons With Incomplete Spinal Cord Injury
Overview
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.
Detailed description
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.
Interventions
- Other Acute Intermittent Hypoxia (AIH)
4 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals
Primary outcome measures
- Change in Serum Blood Brain Derived Neurotrophic Factor [Time frame: Baseline, Day 1, Day 3, and Day 4]
- Change in Serum Serotonin [Time frame: Baseline, Day 1, Day 3, and Day 4]
- Change in the Transcranial Magnetic Stimulation Recruitment Curve Slope [Time frame: Baseline and Day 4]
- Change in Force Steadiness [Time frame: Baseline and Day 4]
- Change in Central Activation Ratio [Time frame: Baseline and Day 4]
- Change in hemoglobin mass [Time frame: Baseline and Day 4]
- Change in Serum Erythropoetin [Time frame: Baseline, Day 1, Day 3, and Day 4]
Secondary outcome measures (3)
- Axial damage ratio [Time frame: Baseline]
- 6-Minute Walk Test [Time frame: Baseline and Day 4]
- 10-Meter Walk Test [Time frame: Baseline and Day 4]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Andrew Tan — Boulder
Identifiers
NCT: NCT06906536 · 23-1275 · 1R03HD115657-01