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Trial record 22 of 1168 for:    spinal cord injury

Respiratory Event-Related Potentials in Patients With Spinal Cord Injury

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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
Sponsor:
Collaborator:
Carolinas Healthcare System
Information provided by (Responsible Party):
Andrew Harver, University of North Carolina, Charlotte

Brief Summary:
Dyspnea is "a subjective experience of breathing discomfort that consists of qualitatively distinct sensations that vary in intensity". It is known 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, but the exact locations have not been well identified. 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. The investigators hypothesize that the perception of breathing varies with the extent of somatosensory information that reaches cerebral cortex.

Condition or disease
Spinal Cord Injury

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Group/Cohort
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).
Controls
Twenty healthy age-matched adults will also participate.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with spinal cord injury will participate in an initial enrollment session at Carolinas Rehabilitation. Patients will be recruited from a registry managed by Dr. Lieberman. Healthy volunteers will be recruited through e-mail solicitation for volunteers for a project examining breathing sensations distributed to faculty, students, and staff in the College of Health and Human Services.
Criteria

Inclusion Criteria:

  • 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. 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.

Exclusion Criteria:

  • History or presence of lung disease (asthma, chronic bronchitis, etc)
  • Current smoker (more than one cigarette per day the past year)
  • History of traumatic brain injury, epilepsy, or seizure; using psychotropic medication of any type
  • And, if patient, more than six months since spinal cord injury and clinically stable.

Information from the National Library of Medicine

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


Locations
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United States, North Carolina
Spinal Cord Injury Medicine, Carolinas Rehabilitation
Charlotte, North Carolina, United States, 28203
UNC Charlotte
Charlotte, North Carolina, United States, 28223
Sponsors and Collaborators
University of North Carolina, Charlotte
Carolinas Healthcare System
Investigators
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Principal Investigator: Andrew Harver, PhD University of North Carolina, Charlotte
Principal Investigator: Jesse A. Lieberman, MD, MSPH Carolinas Healthcare System

Publications:
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Responsible Party: Andrew Harver, Professor, University of North Carolina, Charlotte
ClinicalTrials.gov Identifier: NCT02163551     History of Changes
Other Study ID Numbers: 13-07-09
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

Keywords provided by Andrew Harver, University of North Carolina, Charlotte:
dyspnea
respiratory sensation
event-related potentials
spinal cord injury

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System