Spinal Cord Injuries Clinical Trial
Official title:
Genetic Biomarkers of Intermittent Hypoxia-Induced Respiratory Motor Plasticity in Chronic SCI
Acute intermittent hypoxia (AIH) involves brief (1 min), repeated episodes (~15) of breathing low oxygen air to stimulate spinal neuroplasticity. Animal and human studies show that AIH improves motor function after spinal cord injury, particularly with slightly increased carbon dioxide (hypercapnic AIH; AIHH) and task-specific training. Using a double blind cross-over design, the study will test whether AIHH improves breathing more than AIH and whether specific genetic variations are related to individuals' intervention responses.
Status | Recruiting |
Enrollment | 62 |
Est. completion date | September 2027 |
Est. primary completion date | July 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Adults 18-70 years of age - Chronic SCI for > 1 year, at or below C-3 to T-12 - Incomplete SCI based on residual sensory or motor function below the level of the injury, or injury classification of B, C, D at initial screening, according to the American Spinal Injury Association Impairment Classification, and the International Standards for the Neurological Classification of SCI - Medically stable with physician clearance - SCI due to non-progressive etiology - 20% impairment in maximal inspiratory or expiratory pressure generation, relative to normative values Exclusion Criteria: - Current diagnosis of an additional neurologic condition such as Multiple Sclerosis, Parkinson disease, stroke, or brain injury - Severe illness or infection, including non-healing decubitus ulcers, untreated bladder or urinary tract infections, cardiovascular disease, lung disease, active heterotopic ossification, or uncontrolled hypertension - Severe neuropathic pain - Known pregnancy - Severe recurrent autonomic dysreflexia Exclusion for involvement in TMS - History of seizure disorder, uncontrolled migraines, presence of cardiac pacemaker, metal implants in skull, medications that lower seizure threshold. |
Country | Name | City | State |
---|---|---|---|
United States | Brooks Rehabilitation | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | U.S. Army Medical Research Acquisition Activity |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in motor evoked potential | The change in peak-to-peak amplitude of the motor evoked potential of the diaphragm will be tested using transcranial magnetic stimulation. | Baseline, and 45-60 minutes after intervention on AIH day, AIHH day, and Sham AIH day | |
Primary | Change in maximal inspiratory pressure | Maximal inspiratory pressure is a non-invasive measure of the maximal force achieved when breathing in against an occluded airway. | Baseline, 1 day, 3 days, and 7 days after intervention blocks (daily AIH + respiratory strength training, daily AIHH + respiratory strength training, daily sham AIH + respiratory strength training.) | |
Primary | Change in maximal expiratory pressure | Maximal expiratory pressure is a non-invasive measure of the maximal force achieved when breathing out against an occluded airway. | Baseline, 1 day, 3 days, and 7 days after intervention blocks (daily AIH + respiratory strength training, daily AIHH + respiratory strength training, daily sham AIH + respiratory strength training.) |
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