Spinal Cord InjuriesNCT00116337
Spinal Cord Stimulation to Restore Cough
A study testing Spinal Cord Stimulation to restore cough and Expiratory Muscle Stimulator in people with Spinal Cord Injuries and Spinal Cord Diseases, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
The purpose of this trial is to determine the efficacy of spinal cord stimulation to produce an effective cough in patients with spinal cord injuries. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Diseases, Paralysis
- What is being tested?
- Spinal Cord Stimulation to restore cough and Expiratory Muscle Stimulator
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2004to 31 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable spinal cord injury T5 level or higher
- Expiratory muscle weakness
Who cannot join
- Significant cardiovascular disease
- Active lung disease
- Brain disease
- Scoliosis, chest wall deformity, or marked obesity
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this trial is to determine the efficacy of spinal cord stimulation to produce an effective cough in patients with spinal cord injuries.
Read the detailed description
Patients with cervical and thoracic spinal cord injuries often have paralysis of a major portion of their expiratory muscles - the muscles responsible for coughing - and therefore, lack a normal cough mechanism. Consequently, most of these patients suffer from a markedly reduced ability to clear airway secretions, a factor which contributes to the development of recurrent respiratory tract infections such as pneumonia and bronchitis. Expiratory muscles can be activated by electrical stimulation of the spinal roots to produce a functionally effective cough.
The purpose of this trial is to determine if electrical stimulation of the expiratory muscles is capable of producing an effective cough on demand. According to the trial researchers, if successful, this technique will prevent the need for frequent patient suctioning - which often requires the constant presence of trained personnel. It will also allow spinal cord injured patients to clear their secretions more readily, thereby reducing the incidence of respiratory complications and associated illness and death.
In the trial, researchers will study 18 adults (18-70 years old) with spinal injuries (T5 level or higher), at least 12 months following the date of injury. After an evaluation of medical history, a brief physical examination, and initial testing, participants will have small electrodes (metal discs) placed - by a routine surgical procedure - over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough.
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases, Paralysis, Central Nervous System Diseases, Cough, Trauma, Nervous System
- Being tested
- Spinal Cord Stimulation to restore cough, Expiratory Muscle Stimulator
- Keywords
- spinal cord injury, paralysis, cough, cervical spinal cord injury, thoracic spinal cord injury
- Medical subject headings
- Spinal Cord Injuries, Spinal Cord Diseases, Paralysis, Central Nervous System Diseases, Cough, Trauma, Nervous System, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord Stimulation to restore coughProcedure or surgery
Participants will have small electrodes (metal discs) placed - by a routine surgical procedure - over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are then activated at subsequent study visits using the external control unit.
Expiratory Muscle StimulatorDevice
The expiratory muscle stimulator consists of three small electrodes (metal discs) implanted over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box.
| Study group | Role | What they receive |
|---|---|---|
| Expiratory Muscle Stimulator | Experimental | Procedure/Surgery: spinal cord stimulation to restore cough Receives: Procedure: Spinal Cord Stimulation to restore cough; Device: Expiratory Muscle Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Expiratory Muscle Activation to Generate Large Airway Pressures Characteristic of Normal Cough.
Airway pressure generation achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).
Measured: baseline (pre-implant) and 1 year follow up (post-implant)
Effectiveness of Expiratory Muscle Activation to Generate High Peak Airflows Characteristic of Normal Cough.
Peak airflow achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).
Measured: baseline (pre-implant) and 1 year follow up (post-implant)
Secondary outcomes (2)
Incident of Acute Respiratory Tract Infections
The incidence of acute respiratory tract infections, defined by a change in the character, color, or amount of respiratory secretions and requiring antibiotic administration was tracked over the 2-year period prior to implantation of the cough system. The occurrence of respiratory tract infections was determined by subject history and corroborated by review of medical records, when available. After implantation of the cough system, the incidence of acute respiratory tract infections was tracked continually.
Measured: baseline (pre-implant) and 1 year follow up (post-implant)
Trained Caregiver Support for Secretion Clearance
The degree of caregiver support was determined as the number of times it was necessary for a caregiver to provide the subject with any form of assistive means of secretion clearance including suctioning, manually assisted cough or use of the insufflation-exsufflation device. Caregiver support was evaluated over a 2-week period prior to implantation of the cough stimulation system and continuously over the course of the initial year and again at the 1-year follow-up.
Measured: baseline (pre-implant) and 1 year follow up (post-implant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2005 (estimated)
- Study start30 Sep 2004
- Primary completion10 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony F. Dimarco, MetroHealth Medical Center
- Investigators
- Anthony F. DiMarco, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116337
- Sponsor's protocol ID
- IRB98-00091
- Other IDs
- IRB 98-00091, 278855
- Status last verified
- Apr 2020
- First submitted
- 28 Jun 2005
- Last updated
- 4 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
DiMarco AF, Romaniuk JR, Supinski GS. Electrical activation of the expiratory muscles to restore cough. Am J Respir Crit Care Med. 1995 May;151(5):1466-71. doi: 10.1164/ajrccm.151.5.7735601.
PubMed 7735601DiMarco AF, Romaniuk JR, Kowalski KE, Supinski G. Pattern of expiratory muscle activation during lower thoracic spinal cord stimulation. J Appl Physiol (1985). 1999 Jun;86(6):1881-9. doi: 10.1152/jappl.1999.86.6.1881.
PubMed 10368352DiMarco AF, Romaniuk JR, Kowalski KE, Supinski G. Mechanical contribution of expiratory muscles to pressure generation during spinal cord stimulation. J Appl Physiol (1985). 1999 Oct;87(4):1433-9. doi: 10.1152/jappl.1999.87.4.1433.
PubMed 10517775DiMarco AF, Kowalski KE, Supinski G, Romaniuk JR. Mechanism of expiratory muscle activation during lower thoracic spinal cord stimulation. J Appl Physiol (1985). 2002 Jun;92(6):2341-6. doi: 10.1152/japplphysiol.01231.2001.
PubMed 12015345Romaniuk JR, Dick TE, Kowalski KE, Dimarco AF. Effects of pulse lung inflation on chest wall expiratory motor activity. J Appl Physiol (1985). 2007 Jan;102(1):485-91. doi: 10.1152/japplphysiol.00130.2006. Epub 2006 Sep 7.
PubMed 16959914Kowalski KE, Romaniuk JR, DiMarco AF. Changes in expiratory muscle function following spinal cord section. J Appl Physiol (1985). 2007 Apr;102(4):1422-8. doi: 10.1152/japplphysiol.00870.2006. Epub 2006 Dec 7.
PubMed 17158247DiMarco AF, Kowalski KE, Romaniuk JR. Effects of diaphragm activation on airway pressure generation during lower thoracic spinal cord stimulation. Respir Physiol Neurobiol. 2007 Oct 15;159(1):102-7. doi: 10.1016/j.resp.2007.06.007. Epub 2007 Jun 22.
PubMed 17681870DiMarco AF, Kowalski KE. Effects of chronic electrical stimulation on paralyzed expiratory muscles. J Appl Physiol (1985). 2008 Jun;104(6):1634-40. doi: 10.1152/japplphysiol.01321.2007. Epub 2008 Apr 10.
PubMed 18403449DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR. Spinal cord stimulation: a new method to produce an effective cough in patients with spinal cord injury. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1386-9. doi: 10.1164/rccm.200601-097CR. Epub 2006 Mar 16.
PubMed 16543552DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR, Frost FS, Creasey GH, Nemunaitis GA. Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-Sponsored clinical trial. Part II: clinical outcomes. Arch Phys Med Rehabil. 2009 May;90(5):726-32. doi: 10.1016/j.apmr.2008.11.014.
PubMed 19406290DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR. Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-sponsored clinical trial. Part I: methodology and effectiveness of expiratory muscle activation. Arch Phys Med Rehabil. 2009 May;90(5):717-25. doi: 10.1016/j.apmr.2008.11.013.
PubMed 19406289DiMarco AF, Kowalski KE, Hromyak DR, Geertman RT. Long-term follow-up of spinal cord stimulation to restore cough in subjects with spinal cord injury. J Spinal Cord Med. 2014 Jul;37(4):380-8. doi: 10.1179/2045772313Y.0000000152. Epub 2013 Nov 26.
PubMed 24090524DiMarco AF, Geertman RT, Nemunaitis GA, Kowalski KE. Impact of the cough stimulation system on the care burden and life quality of caregivers of tetraplegics. J Spinal Cord Med. 2023 Sep;46(5):778-788. doi: 10.1080/10790268.2022.2148845. Epub 2023 Apr 5.
PubMed 37017634DiMarco AF, Geertman RT, Nemunaitis GA, Kowalski KE. Comparison of disc and wire electrodes to restore cough via lower thoracic spinal cord stimulation. J Spinal Cord Med. 2022 May;45(3):354-363. doi: 10.1080/10790268.2021.1936388. Epub 2021 Jul 7.
PubMed 34232841
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation to Restore Cough
- ClinicalTrials.gov ID
- NCT00116337
- Acronym / sponsor ID
- IRB98-00091
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases, Paralysis, Central Nervous System Diseases, Cough, Trauma, Nervous System
- Keywords
- spinal cord injury, paralysis, cough, cervical spinal cord injury, thoracic spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 30 Sep 2004 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 29 Jun 2005 (estimated)
- Results
- Posted 13 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to determine the efficacy of spinal cord stimulation to produce an effective cough in patients with spinal cord injuries.
Detailed description
Patients with cervical and thoracic spinal cord injuries often have paralysis of a major portion of their expiratory muscles - the muscles responsible for coughing - and therefore, lack a normal cough mechanism. Consequently, most of these patients suffer from a markedly reduced ability to clear airway secretions, a factor which contributes to the development of recurrent respiratory tract infections such as pneumonia and bronchitis. Expiratory muscles can be activated by electrical stimulation of the spinal roots to produce a functionally effective cough.
The purpose of this trial is to determine if electrical stimulation of the expiratory muscles is capable of producing an effective cough on demand. According to the trial researchers, if successful, this technique will prevent the need for frequent patient suctioning - which often requires the constant presence of trained personnel. It will also allow spinal cord injured patients to clear their secretions more readily, thereby reducing the incidence of respiratory complications and associated illness and death.
In the trial, researchers will study 18 adults (18-70 years old) with spinal injuries (T5 level or higher), at least 12 months following the date of injury. After an evaluation of medical history, a brief physical examination, and initial testing, participants will have small electrodes (metal discs) placed - by a routine surgical procedure - over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expiratory Muscle Stimulator | Experimental | Procedure: Spinal Cord Stimulation to restore cough, Device: Expiratory Muscle StimulatorProcedure/Surgery: spinal cord stimulation to restore cough |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stable spinal cord injury T5 level or higher
- Expiratory muscle weakness
Key exclusion criteria (4 listed)
- Significant cardiovascular disease
- Active lung disease
- Brain disease
- Scoliosis, chest wall deformity, or marked obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Cord Stimulation to restore coughParticipants will have small electrodes (metal discs) placed - by a routine surgical procedure - over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are then activated at subsequent study visits using the external control unit. | Procedure or surgery | Expiratory Muscle Stimulator |
| Expiratory Muscle StimulatorThe expiratory muscle stimulator consists of three small electrodes (metal discs) implanted over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box. | Device | Expiratory Muscle Stimulator |
Primary outcome
Effectiveness of Expiratory Muscle Activation to Generate Large Airway Pressures Characteristic of Normal Cough.
Time frame: baseline (pre-implant) and 1 year follow up (post-implant)
Airway pressure generation achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).
Effectiveness of Expiratory Muscle Activation to Generate High Peak Airflows Characteristic of Normal Cough.
Time frame: baseline (pre-implant) and 1 year follow up (post-implant)
Peak airflow achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).
2 secondary outcomes
Incident of Acute Respiratory Tract Infections
Time frame: baseline (pre-implant) and 1 year follow up (post-implant)
Trained Caregiver Support for Secretion Clearance
Time frame: baseline (pre-implant) and 1 year follow up (post-implant)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7735601DiMarco AF, Romaniuk JR, Supinski GS. Electrical activation of the expiratory muscles to restore cough. Am J Respir Crit Care Med. 1995 May;151(5):1466-71. doi: 10.1164/ajrccm.151.5.7735601.
- Background: PubMed 10368352DiMarco AF, Romaniuk JR, Kowalski KE, Supinski G. Pattern of expiratory muscle activation during lower thoracic spinal cord stimulation. J Appl Physiol (1985). 1999 Jun;86(6):1881-9. doi: 10.1152/jappl.1999.86.6.1881.
- Background: PubMed 10517775DiMarco AF, Romaniuk JR, Kowalski KE, Supinski G. Mechanical contribution of expiratory muscles to pressure generation during spinal cord stimulation. J Appl Physiol (1985). 1999 Oct;87(4):1433-9. doi: 10.1152/jappl.1999.87.4.1433.
- Background: PubMed 12015345DiMarco AF, Kowalski KE, Supinski G, Romaniuk JR. Mechanism of expiratory muscle activation during lower thoracic spinal cord stimulation. J Appl Physiol (1985). 2002 Jun;92(6):2341-6. doi: 10.1152/japplphysiol.01231.2001.
- Background: PubMed 16959914Romaniuk JR, Dick TE, Kowalski KE, Dimarco AF. Effects of pulse lung inflation on chest wall expiratory motor activity. J Appl Physiol (1985). 2007 Jan;102(1):485-91. doi: 10.1152/japplphysiol.00130.2006. Epub 2006 Sep 7.
- Background: PubMed 17158247Kowalski KE, Romaniuk JR, DiMarco AF. Changes in expiratory muscle function following spinal cord section. J Appl Physiol (1985). 2007 Apr;102(4):1422-8. doi: 10.1152/japplphysiol.00870.2006. Epub 2006 Dec 7.
- Background: PubMed 17681870DiMarco AF, Kowalski KE, Romaniuk JR. Effects of diaphragm activation on airway pressure generation during lower thoracic spinal cord stimulation. Respir Physiol Neurobiol. 2007 Oct 15;159(1):102-7. doi: 10.1016/j.resp.2007.06.007. Epub 2007 Jun 22.
- Background: PubMed 18403449DiMarco AF, Kowalski KE. Effects of chronic electrical stimulation on paralyzed expiratory muscles. J Appl Physiol (1985). 2008 Jun;104(6):1634-40. doi: 10.1152/japplphysiol.01321.2007. Epub 2008 Apr 10.
- Results publication: PubMed 16543552DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR. Spinal cord stimulation: a new method to produce an effective cough in patients with spinal cord injury. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1386-9. doi: 10.1164/rccm.200601-097CR. Epub 2006 Mar 16.
- Results publication: PubMed 19406290DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR, Frost FS, Creasey GH, Nemunaitis GA. Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-Sponsored clinical trial. Part II: clinical outcomes. Arch Phys Med Rehabil. 2009 May;90(5):726-32. doi: 10.1016/j.apmr.2008.11.014.
- Results publication: PubMed 19406289DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR. Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-sponsored clinical trial. Part I: methodology and effectiveness of expiratory muscle activation. Arch Phys Med Rehabil. 2009 May;90(5):717-25. doi: 10.1016/j.apmr.2008.11.013.
- Results publication: PubMed 24090524DiMarco AF, Kowalski KE, Hromyak DR, Geertman RT. Long-term follow-up of spinal cord stimulation to restore cough in subjects with spinal cord injury. J Spinal Cord Med. 2014 Jul;37(4):380-8. doi: 10.1179/2045772313Y.0000000152. Epub 2013 Nov 26.
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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.
Anthony F. DiMarco, MD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulation to restore cough and Expiratory Muscle Stimulator in people with Spinal Cord Injuries and Spinal Cord Diseases, run by MetroHealth Medical Center at 1 site 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 2 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: finished, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 13 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effectiveness of Expiratory Muscle Activation to Generate Large Airway Pressures Characteristic of Normal Cough. (time frame: baseline (pre-implant) and 1 year follow up (post-implant)). The study lists 2 primary outcomes in all. 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 NCT00116337, which also lists 14 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 4 May 2020.