Comparison of disc and wire electrodes to restore cough via lower thoracic spinal cord stimulation
Anthony F DiMarco, Robert T Geertman, Gregory A Nemunaitis, Krzysztof E Kowalski, Anthony F DiMarco, Robert T Geertman, Gregory A Nemunaitis, Krzysztof E Kowalski
Abstract
Objective: To compare the safety and effectiveness of wire (WE) vs. disc (DE) electrodes to restore cough in subjects with spinal cord injury (SCI).
Design: Clinical trials assessing the effectiveness and clinical outcomes associated with two electrode systems to activate the expiratory muscles.
Setting: Inpatient hospital setting for DE or WE electrode insertion; outpatient evaluation of cough efficacy and instructions for home use.
Participants: Twenty-nine subjects with SCI; 17 participants with DE and 12 with WE implants.
Intervention: Surgical implantation of WE or DE to restore cough. Daily application of spinal cord stimulation (SCS) at home.
Main outcome measure(s): Airway pressure (P) and peak airflow (F) generation achieved with SCS; clinical parameters including ease in raising secretions, incidence of acute respiratory tract infections (RTI) and side effects.
Results: P and F achieved with DE and WE were not significantly different. For example, at total lung capacity (TLC) with participant effort, P was 128 ± 12 cmH2O and 118 ± 14 cmH2O, with DE and WE, respectively. The degree of difficulty in raising secretions improved markedly in both groups. The incidence of RTI per year fell from 1.3 ± 0.3 and 1.3 ± 0.5-0.3 ± 0.1 and 0.1 ± 0.1 for DE and WE groups, respectively (P< 0.01 for both when compared to pre-implant values and NS between DE and WE groups). The only significant side effect i.e. short-term autonomic dysreflexia was also similar between groups.
Conclusions: The results of this investigation indicate that both DE and WE result in comparable degrees of expiratory muscle activation, clinical benefits and side effects. Importantly, SCS to restore cough can be achieved with use of WE which can be placed using minimally invasive techniques and associated reduction in cost, surgical time and overall risk.Trial registration: ClinicalTrials.gov identifier: NCT00116337., NCT01659541, FDA IDE: G980267.
Keywords: Cough; Rehabilitation; Respiratory muscles; Spinal cord injury; Tetraplegia.
Figures
![Figure 1](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/9135439/bin/YSCM_A_1936388_F0001_OB.jpg)
![Figure 2](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/9135439/bin/YSCM_A_1936388_F0002_OB.jpg)
Figure 3
Mean relationships between P and…
Figure 3
Mean relationships between P and F generation during SCS (50 Hz, 40 V,…
Figure 4
Subject responses to frequency of…
Figure 4
Subject responses to frequency of need for conventional means of secretion clearance, severity…
Figure 5
There was a significant reduction…
Figure 5
There was a significant reduction in the incidence of acute respiratory tract infections…
- 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.DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR. DiMarco AF, et al. Arch Phys Med Rehabil. 2009 May;90(5):717-25. doi: 10.1016/j.apmr.2008.11.013. Arch Phys Med Rehabil. 2009. PMID: 19406289 Free PMC article. Clinical Trial.
- Case report: Minimally invasive method to activate the expiratory muscles to restore cough.DiMarco AF, Geertman RT, Tabbaa K, Polito RR, Kowalski KE. DiMarco AF, et al. J Spinal Cord Med. 2018 Sep;41(5):562-566. doi: 10.1080/10790268.2017.1357916. Epub 2017 Oct 11. J Spinal Cord Med. 2018. PMID: 29017400 Free PMC article.
- 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.DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR, Frost FS, Creasey GH, Nemunaitis GA. DiMarco AF, et al. Arch Phys Med Rehabil. 2009 May;90(5):726-32. doi: 10.1016/j.apmr.2008.11.014. Arch Phys Med Rehabil. 2009. PMID: 19406290 Free PMC article. Clinical Trial.
- Restoration of respiratory muscle function following spinal cord injury. Review of electrical and magnetic stimulation techniques.DiMarco AF. DiMarco AF. Respir Physiol Neurobiol. 2005 Jul 28;147(2-3):273-87. doi: 10.1016/j.resp.2005.03.007. Respir Physiol Neurobiol. 2005. PMID: 16046197 Review.
- Review of Epidural Spinal Cord Stimulation for Augmenting Cough after Spinal Cord Injury.Hachmann JT, Calvert JS, Grahn PJ, Drubach DI, Lee KH, Lavrov IA. Hachmann JT, et al. Front Hum Neurosci. 2017 Mar 28;11:144. doi: 10.3389/fnhum.2017.00144. eCollection 2017. Front Hum Neurosci. 2017. PMID: 28400726 Free PMC article. Review.
- Effects of restoration of cough via spinal cord stimulation on subject quality of life.DiMarco AF, Geertman RT, Nemunaitis GA, Kowalski KE. DiMarco AF, et al. J Clin Orthop Trauma. 2022 Sep 27;34:102027. doi: 10.1016/j.jcot.2022.102027. eCollection 2022 Nov. J Clin Orthop Trauma. 2022. PMID: 36212771
- Clinical Trial
- Research Support, Non-U.S. Gov't
- Research Support, N.I.H., Extramural
- Cough / therapy
- Electrodes, Implanted
- Humans
- Respiratory Muscles / physiology
- Spinal Cord
- Spinal Cord Injuries* / complications
- Spinal Cord Stimulation* / adverse effects
- Spinal Cord Stimulation* / methods
- ClinicalTrials.gov/NCT00116337
- ClinicalTrials.gov/NCT01659541
- ClinicalTrials.gov/NCT00116337
- Full Text Sources
- Medical
- Miscellaneous
NCBI Literature Resources
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![Figure 3](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/9135439/bin/YSCM_A_1936388_F0003_OB.jpg)
![Figure 4](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/9135439/bin/YSCM_A_1936388_F0004_OB.jpg)
Figure 5
There was a significant reduction…
Figure 5
There was a significant reduction in the incidence of acute respiratory tract infections…
- 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.DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR. DiMarco AF, et al. Arch Phys Med Rehabil. 2009 May;90(5):717-25. doi: 10.1016/j.apmr.2008.11.013. Arch Phys Med Rehabil. 2009. PMID: 19406289 Free PMC article. Clinical Trial.
- Case report: Minimally invasive method to activate the expiratory muscles to restore cough.DiMarco AF, Geertman RT, Tabbaa K, Polito RR, Kowalski KE. DiMarco AF, et al. J Spinal Cord Med. 2018 Sep;41(5):562-566. doi: 10.1080/10790268.2017.1357916. Epub 2017 Oct 11. J Spinal Cord Med. 2018. PMID: 29017400 Free PMC article.
- 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.DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR, Frost FS, Creasey GH, Nemunaitis GA. DiMarco AF, et al. Arch Phys Med Rehabil. 2009 May;90(5):726-32. doi: 10.1016/j.apmr.2008.11.014. Arch Phys Med Rehabil. 2009. PMID: 19406290 Free PMC article. Clinical Trial.
- Restoration of respiratory muscle function following spinal cord injury. Review of electrical and magnetic stimulation techniques.DiMarco AF. DiMarco AF. Respir Physiol Neurobiol. 2005 Jul 28;147(2-3):273-87. doi: 10.1016/j.resp.2005.03.007. Respir Physiol Neurobiol. 2005. PMID: 16046197 Review.
- Review of Epidural Spinal Cord Stimulation for Augmenting Cough after Spinal Cord Injury.Hachmann JT, Calvert JS, Grahn PJ, Drubach DI, Lee KH, Lavrov IA. Hachmann JT, et al. Front Hum Neurosci. 2017 Mar 28;11:144. doi: 10.3389/fnhum.2017.00144. eCollection 2017. Front Hum Neurosci. 2017. PMID: 28400726 Free PMC article. Review.
- Effects of restoration of cough via spinal cord stimulation on subject quality of life.DiMarco AF, Geertman RT, Nemunaitis GA, Kowalski KE. DiMarco AF, et al. J Clin Orthop Trauma. 2022 Sep 27;34:102027. doi: 10.1016/j.jcot.2022.102027. eCollection 2022 Nov. J Clin Orthop Trauma. 2022. PMID: 36212771
- Clinical Trial
- Research Support, Non-U.S. Gov't
- Research Support, N.I.H., Extramural
- Cough / therapy
- Electrodes, Implanted
- Humans
- Respiratory Muscles / physiology
- Spinal Cord
- Spinal Cord Injuries* / complications
- Spinal Cord Stimulation* / adverse effects
- Spinal Cord Stimulation* / methods
- ClinicalTrials.gov/NCT00116337
- ClinicalTrials.gov/NCT01659541
- ClinicalTrials.gov/NCT00116337
- Full Text Sources
- Medical
- Miscellaneous
![Figure 5](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/9135439/bin/YSCM_A_1936388_F0005_OB.jpg)
Source: PubMed