Atlanta, Georgia 30322


Purpose:

Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) is a safe and effective treatment strategy to promote meaningful functional recovery in persons with chronic spinal cord injury (SCI). The goal of the study is to understand how caffeine may augment the effects of intermittent hypoxia on motor function and spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences) following SCI.


Study summary:

The investigators will examine the effects of acute intermittent hypoxia (AIH) as a possible therapeutic intervention to promote functionally useful motor recovery. In this sub-study, the investigators will assess changes in leg motor function in response to repetitive AIH with and without caffeine. Participants will receive caffeine+AIH, placebo+AIH, caffeine+SHAM, and placebo+SHAM in a randomized order. Before each intervention round, subjects will be asked to avoid caffeine-containing substances for 48 hrs (> 5* half-life of ~7 hrs) prior to arrival to control for baseline plasma levels of caffeine. Subjects will then ingest capsules containing either placebo (dextrose) or caffeine (up to 6mg/kg). Capsules will be prepared by Emory University Investigational Drug Services. Saliva samples will be collected before and after the breathing intervention using a standard passive drool protocol to assess caffeine concentrations within the body. The subject will be asked to collect saliva in their mouth and drool into a vial. During and after each intervention, both the rate and extent of magnitude changes in voluntary and involuntary motor response behaviors will be compared between interventions within participants. Repeated measurements will be collected on all subjects that participate in the multiple interventions.


Criteria:

Inclusion Criteria: - age 18 and 77 years (the latter to reduce likelihood of heart disease) - medical clearance to participate - lesion at or below C2 and above T12 with non-progressive etiology - classified as motor-incomplete with visible volitional leg movement - injury greater than 1 year Exclusion Criteria: - Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of pulmonary complications) - Pregnant women because of the unknown affects of AIH on pregnant women and fetus - History of seizures, brain injury, and/or epilepsy - Diagnosed with severe obstructive sleep apnea (OSA). The existence of severe OSA during non-rapid eye movement sleep may be suggestive of pulmonary obstructions, a potential confound for this study. Subjects will be monitored for breathing patterns during sleep for one night to assess for symptoms of OSA. A portable sleep-screening tool [ApneaLink, USA] that records up to 10 continuous hours of heart rate, respiration, and SaO2 will be used to screen potential subjects. Those persons with an apnea-hypopnea index (AHI), corresponding to a combined number of apneas and hypopneas that occur per hour of sleep, of greater than 30 will be excluded - Undergoing concurrent physical therapy - Diabetes - Cirrhosis - Caffeine and/or NSAID allergies or intolerances


NCT ID:

NCT02323698


Primary Contact:

Principal Investigator
Randy D Trumbower, PT, PhD
Emory University

Randy D Trumbower, PT, PhD
Phone: 404-712-5985
Email: randy.trumbower@emory.edu


Backup Contact:

Email: labtrumbower@gmail.com
Denise Peters, PT, PhD
Phone: 404-712-5985


Location Contact:

Atlanta, Georgia 30322
United States

Randy D Trumbower, PT, PhD
Phone: 404-727-3065
Email: randy.trumbower@emory.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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