- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01659541
Stimulation With Wire Leads to Restore Cough
Spinal Cord Stimulation With Wire Leads to Restore Cough
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with cervical 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 by wire leads 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 16 adults (18-75 years old) with cervical spinal injuries (C8 level or higher), at least 6 months following the date of injury. After an evaluation of medical history, a brief physical examination, and initial testing, participants will have wire leads placed - by a routine, minimally invasive surgical procedure - over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44109
- MetroHealth Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Spinal cord injury C8 level or higher
- 12 months post-injury (if the American Spinal Injury Association (ASIA) Impairment Scale (AIS) incomplete) or 6 months post-injury (if AIS complete)
- Expiratory muscle weakness
- Between 18 and 75 years of age
- Adequate oxygenation
Exclusion Criteria:
- Untreated lung, cardiovascular or brain disease
- Scoliosis, chest wall deformity, or marked obesity
- Unmanaged hypertension (high blood pressure) or hypotension (low blood pressure)
- Low oxygenation
- Minor infection at the site of implantation requiring antibiotics within the past 3 weeks
- Serious infection requiring hospitalization within the past 6 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Procedure & Device
Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator
|
The expiratory muscle stimulator consists of two small electrodes (wire leads) implanted on the surface of the spinal cord 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.
Other Names:
The expiratory muscle stimulator consists of two wire leads(each with two metal contacts) inserted onto the surface of their spinal cord on the lower back using a needle.
The procedure to implant these wire leads is commonly used today for other purposes.
This is a minimally invasive surgical technique with minimal risks.
The wire leads 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 to stimulate the expiratory muscles and restore cough.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough.
Time Frame: 52 weeks (1 year)
|
Peak Expiratory airflow rate is a person's maximum speed of expiration.
Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration.
It was measured after release of airway occlusion after peak airway pressure was achieved.
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52 weeks (1 year)
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Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough
Time Frame: 52 weeks (1 year)
|
Maximum expiratory pressure is the highest pressure that can be developed during a forceful expiratory effort against an occluded airway.
|
52 weeks (1 year)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secretion Management Episodes
Time Frame: 52 weeks (1 year)
|
This assessment allowed to characterize the severity of secretion management episodes and subjective assessment of the need for secretion management before and after use of the Cough System. Design: Prospective assessment via questionnaire responses Question: How significant were your needs for assistance with managing your airway secretions on a typical day during the past week? 0 None - Unaware of need
|
52 weeks (1 year)
|
Difficulty Raising Sputum
Time Frame: 52 weeks (1 year)
|
Survey to assess difficulty raising sputum Objectives: To determine the difficulty raising sputum before and after use of the cough stimulation system (Cough System) Design: Prospective assessment via questionnaire responses Question: How much difficulty have you had with managing your airway secretions? On a scale of 0-4 (0 = None (No secretions), 1 = Mild (Rarely have difficulty), 2 = Moderate (Occasional difficulty) 3 = Marked (Frequent difficulty) and 4=Severe (Usually have great difficulty). |
52 weeks (1 year)
|
Number of Respiratory Tract Infections
Time Frame: 52 weeks (1 year)
|
Form covers frequency, type, severity, and antibiotic use for 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 before and after 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. |
52 weeks (1 year)
|
Life Quality Assessment -Stress Level
Time Frame: 52 weeks (1 year)
|
Survey will assess the subject's quality of life at home and in social situations, as well as assess specific need for managing secretions. Objectives: Life Quality Assessment before and after use of the cough stimulation system (Cough System) Design: Prospective assessment via questionnaire responses Question: To what extent did managing your airway secretions cause you stress? On a scale of 0-3 (0 = Not at all, 1 = a little, 2 = Quite a bit and 3 = Very much) |
52 weeks (1 year)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anthony F. DiMarco, MD, MetroHealth Medical Center
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Kowalski KE, DiMarco AF. Comparison of wire and disc leads to activate the expiratory muscles in dogs. J Spinal Cord Med. 2011 Nov;34(6):600-8. doi: 10.1179/2045772311Y.0000000039.
- 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.
- 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.
- 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.
- Wada JA, Osawa T, Mizoguchi T. Recurrent spontaneous seizure state induced by prefrontal kindling in senegalese baboons, Papio papio. Can J Neurol Sci. 1975 Nov;2(4):477-92. doi: 10.1017/s031716710002062x.
- 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.
- 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.
- 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.
- 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.
- 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.
- DiMarco AF, Geertman RT, Tabbaa K, Polito RR, Kowalski KE. Economic Consequences of an Implanted Neuroprosthesis in Subjects with Spinal Cord Injury for Restoration of an Effective Cough. Top Spinal Cord Inj Rehabil. 2017 Summer;23(3):271-278. doi: 10.1310/sci2303-271.
- DiMarco AF, Geertman RT, Tabbaa K, Polito RR, Kowalski KE. Case report: Minimally invasive method to activate the expiratory muscles to restore cough. J Spinal Cord Med. 2018 Sep;41(5):562-566. doi: 10.1080/10790268.2017.1357916. Epub 2017 Oct 11.
- DiMarco AF, Geertman RT, Tabbaa K, Kowalski KE. Complete Restoration of Respiratory Muscle Function in Three Subjects With Spinal Cord Injury: Pilot Interventional Clinical Trial. Am J Phys Med Rehabil. 2019 Jan;98(1):43-50. doi: 10.1097/PHM.0000000000001018.
- DiMarco AF, Geertman RT, Tabbaa K, Nemunaitis GA and Kowalski KE. Case Report: Effects of Lower Thoracic Spinal Cord Stimulation on Bowel Management in a Person with Spinal Cord Injury. Journal of Neurology and Neurobiology (2019) Volume 5 - Issue 1 | DOI: http://dx.doi.org/10.16966/2379-7150.156.
- DiMarco AF, Geertman RT, Tabbaa K, Kowalski KE. Complete Restoration of Respiratory Muscle Function in Subjects With Spinal Cord Injury: Interventional Clinical Trial. Am J Phys Med Rehabil. 2020 Jul;99(7):e91-e92. doi: 10.1097/PHM.0000000000001338. No abstract available.
- DiMarco AF, Geertman RT, Tabbaa K, Nemunaitis GA, Kowalski KE. Restoration of cough via spinal cord stimulation improves pulmonary function in tetraplegics. J Spinal Cord Med. 2020 Sep;43(5):579-585. doi: 10.1080/10790268.2019.1699678. Epub 2019 Dec 6.
- DiMarco AF, Geertman RT, Tabbaa K, Nemunaitis GA, Kowalski KE. Effects of Lower Thoracic Spinal Cord Stimulation on Bowel Management in Individuals With Spinal Cord Injury. Arch Phys Med Rehabil. 2021 Jun;102(6):1155-1164. doi: 10.1016/j.apmr.2020.09.394. Epub 2020 Nov 5.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 15-00014
- U01NS083696 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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