Respiratory Event-Related Potentials in Patients With Spinal Cord Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02163551|
Recruitment Status : Terminated (Recurrent equipment failures (used with custom EEG and ERP recording software) precluded timely data collection and analysis activities.)
First Posted : June 13, 2014
Last Update Posted : October 30, 2017
|Condition or disease|
|Spinal Cord Injury|
Dyspnea is "a subjective experience of breathing discomfort that consists of qualitatively distinct sensations that vary in intensity." Dyspnea, or shortness of breath, is a common problem affecting up to half of hospitalized patients; and "shortness of breath" and "labored or difficult breathing" accounts for 3 to 4 million emergency department visits annually. Dyspnea can represent a sensation, a symptom, or an illness. Each set of experiences involves distinct sensory, perceptual, and cognitive processes, including: the detection of signals; the perception of threat or remarkable challenge; and, the construction, or mental representation, of illness. As a sensory experience dyspnea can be compared to the sensation of pain. Although labored breathing is not painful in the usual sense of the word dyspnea, like pain, is a concept varying along multiple dimensions. Like pain, dyspnea can signal the need for medical attention; but unlike pain dyspnea is a localized sensation originating in the cardiopulmonary system rather than a generalized danger signal.
Research demonstrates that sensory information from the respiratory system activates regions of the cerebral cortex to produce the perception of dyspnea but far less is known about the neurophysiology of dyspnea than about vision, hearing, or even pain. Dyspnea likely arises from multiple nervous system sources. Investigations of the mechanisms underlying respiratory sensations have included studies of airway anesthesia, chest wall strapping, exercise, heart-lung transplantation, hyperventilation, and opioid use. Study of the perception of breathing sensations in individuals with a spinal cord injury presents additional opportunity. The goal of the proposed project is to examine the effects of increasingly severe levels of spinal cord injury on the perception of breathing sensations in participants who are able to breathe without the use of a ventilator.
Afferent pathways that transmit somatosensory signals to the central nervous system (i.e., brain and spinal cord) are well described and event-related potentials have been used to measure respiratory somatosensation with high temporal resolution. Event-related potentials (ERPs) are time-locked cortical signals that are measured non-invasively from the surface of the scalp in response to brief (< 200 msec), presentations of respiratory stimuli during normal breathing. Davenport et al. first identified sensory-perceptual ERPs to inspiratory stimuli (those occurring about 50-150 msec after stimulus delivery) and Harver et al. first examined perceptual-cognitive ERPs to inspiratory stimuli (those occurring about 150-400 msec post-stimulus). Study of respiratory-related ERPs in patients with spinal cord injuries presents a rare opportunity to examine the neurophysiological mechanisms underlying the perception of breathing because the extent of somatosensory information that reaches cerebral cortex varies with level of lesion.
|Study Type :||Observational|
|Actual Enrollment :||14 participants|
|Official Title:||Respiratory Event-Related Potentials in Patients With Spinal Cord Injury: An Evaluation of Somatosensory Afferents|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
Spinal Cord Injury
Participants with spinal cord injury (n = 20) will be age 30-60 years with motor complete spinal cord injuries, otherwise known as American Spinal Injury Association (ASIA) classification A or B, between the levels of C3 and T12. Patients will have to be able to breathe independently without the use of a ventilator. Subjects will be divided equally into four different injury level categories. The four categories are high tetraplegia (C3 - C5), low tetraplegia (C6-C8), high paraplegia (T1-T6), and low paraplegia (T7-T12).
Twenty healthy age-matched adults will also participate.
- Event-Related Potentials [ Time Frame: Baseline, 2-3 hours ]To record event-related potentials, surface electrodes will be attached with electrode collars and paper tape. Electrodes will be positioned at Fz (frontal midline), Cz (central midline), Pz (parietal midline), 1 cm below the center of the right eye to monitor eye movements, on the right mastoid (reference site), and on the forehead (ground site).
- General Health Status [ Time Frame: Baseline,1 hour ]Participants will complete general and respiratory health histories, a standardized Respiratory Disease Questionnaire, and a measure of quality of life (SF-36).
- Lung Function [ Time Frame: Baseline, 1 hour ]Participants perform lung function testing, hold their breaths for as a long as possible, and produce maximal inspiratory and expiratory efforts against a closed airway.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163551
|United States, North Carolina|
|Spinal Cord Injury Medicine, Carolinas Rehabilitation|
|Charlotte, North Carolina, United States, 28203|
|Charlotte, North Carolina, United States, 28223|
|Principal Investigator:||Andrew Harver, PhD||University of North Carolina, Charlotte|
|Principal Investigator:||Jesse A. Lieberman, MD, MSPH||Atrium Health|