Spinal Cord InjuryNCT02163551
Respiratory Event-Related Potentials in Patients With Spinal Cord Injury
An observational study of Spinal Cord Injury, run by University of North Carolina, Charlotte at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2014to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Spinal Cord Injury Medicine, Carolinas Rehabilitation
Charlotte, North Carolina, 28203
UNC Charlotte
Charlotte, North Carolina, 28223
About this study
Official title: Respiratory Event-Related Potentials in Patients With Spinal Cord Injury: An Evaluation of Somatosensory Afferents
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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Keywords
- dyspnea, respiratory sensation, event-related potentials, spinal cord injury
- Medical subject headings
- Spinal Cord Injuries, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Related Potentials
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).
Measured: Baseline, 2-3 hours
Secondary outcomes (1)
General Health Status
Participants will complete general and respiratory health histories, a standardized Respiratory Disease Questionnaire, and a measure of quality of life (SF-36).
Measured: Baseline,1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Recurrent equipment failures (used with custom EEG and ERP recording software) precluded timely data collection and analysis activities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Charlotte
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences
- Responsible party
- Principal investigator, Andrew Harver, University of North Carolina, Charlotte
- Investigators
- Andrew Harver, PhD, Principal investigator, University of North Carolina, CharlotteJesse A. Lieberman, MD, MSPH, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163551
- Sponsor's protocol ID
- 13-07-09
- Status last verified
- Oct 2017
- First submitted
- 10 Jun 2014
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.
PubMed 22336677Bloch-Salisbury E, Harver A, Squires NK. Event-related potentials to inspiratory flow-resistive loads in young adults: stimulus magnitude effects. Biol Psychol. 1998 Sep;49(1-2):165-86. doi: 10.1016/s0301-0511(98)00034-9.
PubMed 9792492Harver A, Squires NK, Bloch-Salisbury E, Katkin ES. Event-related potentials to airway occlusion in young and old subjects. Psychophysiology. 1995 Mar;32(2):121-9. doi: 10.1111/j.1469-8986.1995.tb03303.x.
PubMed 7630976Bloch-Salisbury E, Harver A. Effects of detection and classification of resistive and elastic loads on endogenous event-related potentials. J Appl Physiol (1985). 1994 Sep;77(3):1246-55. doi: 10.1152/jappl.1994.77.3.1246.
PubMed 7836128Davenport PW, Friedman WA, Thompson FJ, Franzen O. Respiratory-related cortical potentials evoked by inspiratory occlusion in humans. J Appl Physiol (1985). 1986 Jun;60(6):1843-8. doi: 10.1152/jappl.1986.60.6.1843.
PubMed 3722053
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Event-Related Potentials in Patients With Spinal Cord Injury: An Evaluation of Somatosensory Afferents
- ClinicalTrials.gov ID
- NCT02163551
- Acronym / sponsor ID
- 13-07-09
- Conditions
- Spinal Cord Injury
- Keywords
- dyspnea, respiratory sensation, event-related potentials, spinal cord injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recurrent equipment failures (used with custom EEG and ERP recording software) precluded timely data collection and analysis activities.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of North Carolina, CharlotteUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences
- Study start
- Jun 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
General Health Status
Time frame: Baseline,1 hour
Results and safety
The study was stopped early (reason given: Recurrent equipment failures (used with custom EEG and ERP recording software) precluded timely data collection and analysis activities.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Background: PubMed 22336677Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.
- Background: PubMed 9792492Bloch-Salisbury E, Harver A, Squires NK. Event-related potentials to inspiratory flow-resistive loads in young adults: stimulus magnitude effects. Biol Psychol. 1998 Sep;49(1-2):165-86. doi: 10.1016/s0301-0511(98)00034-9.
- Background: PubMed 7630976Harver A, Squires NK, Bloch-Salisbury E, Katkin ES. Event-related potentials to airway occlusion in young and old subjects. Psychophysiology. 1995 Mar;32(2):121-9. doi: 10.1111/j.1469-8986.1995.tb03303.x.
- Background: PubMed 7836128Bloch-Salisbury E, Harver A. Effects of detection and classification of resistive and elastic loads on endogenous event-related potentials. J Appl Physiol (1985). 1994 Sep;77(3):1246-55. doi: 10.1152/jappl.1994.77.3.1246.
- Background: PubMed 3722053Davenport PW, Friedman WA, Thompson FJ, Franzen O. Respiratory-related cortical potentials evoked by inspiratory occlusion in humans. J Appl Physiol (1985). 1986 Jun;60(6):1843-8. doi: 10.1152/jappl.1986.60.6.1843.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Harver, PhD principal investigator
University of North Carolina, Charlotte
Jesse A. Lieberman, MD, MSPH principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by University of North Carolina, Charlotte at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recurrent equipment failures (used with custom EEG and ERP recording software) precluded timely data collection and analysis activities.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-Related Potentials (time frame: Baseline, 2-3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02163551, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.