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| ID | Type | Description | Link |
|---|---|---|---|
| IRB 98-00091 | |||
| 278855 | Other Grant/Funding Number | Neilsen Foundation |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expiratory Muscle Stimulator | Experimental | Procedure/Surgery: spinal cord stimulation to restore cough |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulation to restore cough | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | baseline (pre-implant) and 1 year follow up (post-implant) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony F. DiMarco, MD | MetroHealth Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7735601 | Background | 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. | |
| 10368352 | Background | DiMarco 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. |
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Subjects were well informed of the details of the study, with particular interest to risks/benefits, and asked to review the Informed Consent before signing.They were given an opportunity to ask questions. Consent was obtained only after all questions and concerns have been addressed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinical Trial - Spinal Cord Stimulation to Restore Cough | Design: Clinical trial. Participants: Subjects with cervical spinal cord injury and weak cough. Interventions: A fully implantable electrical stimulation system was surgically placed in each subject. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinical Trial - Spinal Cord Stimulation Cough System | Design: Clinical trial. Participants: Subjects with cervical spinal cord injury and weak cough. Interventions: A fully implantable electrical stimulation system was surgically placed in each subject. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Male - 14; Female - 3 | Posted | Mean | Standard Error | cmH2O | baseline (pre-implant) and 1 year follow up (post-implant) |
|
5 year follow up (post-implant)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Post-Implantation - Spinal Cord Stimulation (SCS) | Hemodynamic effects: Increases in blood pressure in association with the initial application of SCS. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment | There were no postoperative infections. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemodynamic effects: Decreases in pulse rate | Nervous system disorders | Systematic Assessment | Hemodynamic effects: Decreases in pulse rate in association with the initial application of SCS. With the application of chronic daily stimulation, these changes gradually diminished. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anthony Dimarco | MetroHealth Medical Center | 216-778-3906 | adimarco@metrohealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 27, 2011 | Feb 7, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 27, 2011 | Feb 7, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 27, 2011 | Feb 7, 2020 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D013118 | Spinal Cord Diseases |
| D010243 | Paralysis |
| D002493 | Central Nervous System Diseases |
| D003371 | Cough |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Expiratory Muscle Stimulator | Device | 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. |
|
| 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. | baseline (pre-implant) and 1 year follow up (post-implant) |
| 10517775 | Background | DiMarco 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. |
| 12015345 | Background | DiMarco 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. |
| 16959914 | Background | Romaniuk 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. |
| 17158247 | Background | Kowalski 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. |
| 17681870 | Background | DiMarco 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. |
| 18403449 | Background | DiMarco 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. |
| 16543552 | Result | DiMarco 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. |
| 19406290 | Result | DiMarco 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. |
| 19406289 | Result | DiMarco 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. |
| 24090524 | Result | DiMarco 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. |
| 37017634 | Derived | DiMarco 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. |
| 34232841 | Derived | DiMarco 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. |
| Participants |
|
| Sex: Female, Male | Overview of study participants | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
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| Primary | 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). | Male - 14; Female - 3 | Posted | Mean | Standard Error | L/s | baseline (pre-implant) and 1 year follow up (post-implant) |
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|
|
| Secondary | 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. | Male - 14; Female - 3 | Posted | Mean | Standard Error | Intections per year | baseline (pre-implant) and 1 year follow up (post-implant) |
|
|
|
|
| Secondary | 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. | Male - 14; Female - 3 | Posted | Mean | Standard Error | times/week | baseline (pre-implant) and 1 year follow up (post-implant) |
|
|
|
| 0 |
| 17 |
| 1 |
| 17 |
| 3 |
| 17 |
|
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| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |