Long-term follow-up of spinal cord stimulation to restore cough in subjects with spinal cord injury
Anthony F DiMarco, Krzysztof E Kowalski, Dana R Hromyak, Robert T Geertman, Anthony F DiMarco, Krzysztof E Kowalski, Dana R Hromyak, Robert T Geertman
Abstract
Objective: To determine the long-term effects of the cough stimulation system.
Design: Nonrandomized clinical trial of subjects using the study device well beyond the period of close follow-up.
Setting: Use of the study device in the home setting.
Participants: Subjects (N = 10) implanted with the device for a minimum of 2 years (mean 4.6 ± 0.6 years).
Interventions: Application of daily stimulation.
Outcome measures: Airway pressure generation and other clinical assessments including ease in raising secretions, life quality, caregiver support, and incidence of respiratory tract infections were measured at 1 year and mean 4.6 years after implantation.
Results: Each subject continued to use the device on a regular basis. During SCS, mean maximum airway pressures were 103.1 ± 20.4 and 107.7 ± 23.0 cm H₂O at the 1-year and mean 4.6-year follow-up points, respectively (P < 0.05 compared with pre-implant and not significantly different (NS) compared with 1-year follow-up). Benchmarks related to ease in raising secretions and improvements in life quality related to respiratory care were maintained at the mean 4.6 year follow-up. The need for trained caregivers to provide other means of secretion management remained significantly below the pre-implant values (P < 0.05). The incidence of acute respiratory tract infections remained low at 0.2 ± 0.1 events/year, which is significantly below the pre-implant value of 1.4 ± 0.3 events/year (P < 0.05).
Conclusion: Subjects continued to use the system on a long-term basis beyond the period of close follow-up and to continued derive significant clinical benefits.
Keywords: Cough; Expiratory muscles; Spinal cord stimulation.
Figures
![Figure 1](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4116721/bin/scm-37-380.01.jpg)
![Figure 2](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4116721/bin/scm-37-380.02.jpg)
Figure 3
Subject responses to life quality…
Figure 3
Subject responses to life quality assessment related to secretion management. There was improvement…
Figure 3
Subject responses to life quality…
Figure 3
Subject responses to life quality assessment related to secretion management. There was improvement…
Figure 4
Compared with pre-implant, there were…
Figure 4
Compared with pre-implant, there were significant reductions in the need for caregiver support…
Figure 5
There was a significant reduction…
Figure 5
There was a significant reduction in the incidence of acute respiratory tract infections…
- Comparison of disc and wire electrodes to restore cough via lower thoracic spinal cord stimulation.DiMarco AF, Geertman RT, Nemunaitis GA, Kowalski KE. DiMarco AF, et al. J Spinal Cord Med. 2022 May;45(3):354-363. doi: 10.1080/10790268.2021.1936388. Epub 2021 Jul 7. J Spinal Cord Med. 2022. PMID: 34232841 Free PMC article. Clinical Trial.
- 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.
- Economic Consequences of an Implanted Neuroprosthesis in Subjects with Spinal Cord Injury for Restoration of an Effective Cough.DiMarco AF, Geertman RT, Tabbaa K, Polito RR, Kowalski KE. DiMarco AF, et al. Top Spinal Cord Inj Rehabil. 2017 Summer;23(3):271-278. doi: 10.1310/sci2303-271. Top Spinal Cord Inj Rehabil. 2017. PMID: 29339903 Free PMC article.
- Restoration of cough via spinal cord stimulation improves pulmonary function in tetraplegics.DiMarco AF, Geertman RT, Tabbaa K, Nemunaitis GA, Kowalski KE. DiMarco AF, et al. J Spinal Cord Med. 2020 Sep;43(5):579-585. doi: 10.1080/10790268.2019.1699678. Epub 2019 Dec 6. J Spinal Cord Med. 2020. PMID: 31809251 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 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.
- Narrative review of current neuromodulation modalities for spinal cord injury.Medina R, Ho A, Reddy R, Chen J, Castellanos J. Medina R, et al. Front Pain Res (Lausanne). 2023 Mar 9;4:1143405. doi: 10.3389/fpain.2023.1143405. eCollection 2023. Front Pain Res (Lausanne). 2023. PMID: 36969918 Free PMC article. Review.
- Regulation of Human Respiration by Electrical Stimulation.Shandybina ND, Kuropatenko MV, Moshonkina TR. Shandybina ND, et al. J Evol Biochem Physiol. 2022;58(6):1879-1891. doi: 10.1134/S0022093022060175. Epub 2022 Dec 22. J Evol Biochem Physiol. 2022. PMID: 36573159 Free PMC article.
- 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
- Comparison of disc and wire electrodes to restore cough via lower thoracic spinal cord stimulation.DiMarco AF, Geertman RT, Nemunaitis GA, Kowalski KE. DiMarco AF, et al. J Spinal Cord Med. 2022 May;45(3):354-363. doi: 10.1080/10790268.2021.1936388. Epub 2021 Jul 7. J Spinal Cord Med. 2022. PMID: 34232841 Free PMC article. Clinical Trial.
- Design and Testing of Stimulation and Myoelectric Recording Modules in an Implanted Distributed Neuroprosthetic System.Makowski N, Campean A, Lambrecht J, Buckett J, Coburn J, Hart R, Miller M, Montague F, Crish T, Fu M, Kilgore K, Peckham PH, Smith B. Makowski N, et al. IEEE Trans Biomed Circuits Syst. 2021 Apr;15(2):281-293. doi: 10.1109/TBCAS.2021.3066838. Epub 2021 May 25. IEEE Trans Biomed Circuits Syst. 2021. PMID: 33729949 Free PMC article.
- Adult
- Cohort Studies
- Cough / etiology*
- Cough / therapy*
- Electroconvulsive Therapy / methods*
- Female
- Humans
- Male
- Middle Aged
- Pulmonary Ventilation / physiology
- Respiratory Tract Infections / etiology
- Spinal Cord / physiology*
- Spinal Cord Injuries / complications*
- Time Factors
- Treatment Outcome
- Young Adult
- Full Text Sources
- Other Literature Sources
- Medical
- Miscellaneous
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![Figure 3](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4116721/bin/scm-37-380.03a.jpg)
![Figure 3](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4116721/bin/scm-37-380.03b.jpg)
![Figure 4](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4116721/bin/scm-37-380.04.jpg)
Figure 5
There was a significant reduction…
Figure 5
There was a significant reduction in the incidence of acute respiratory tract infections…
- Comparison of disc and wire electrodes to restore cough via lower thoracic spinal cord stimulation.DiMarco AF, Geertman RT, Nemunaitis GA, Kowalski KE. DiMarco AF, et al. J Spinal Cord Med. 2022 May;45(3):354-363. doi: 10.1080/10790268.2021.1936388. Epub 2021 Jul 7. J Spinal Cord Med. 2022. PMID: 34232841 Free PMC article. Clinical Trial.
- 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.
- Economic Consequences of an Implanted Neuroprosthesis in Subjects with Spinal Cord Injury for Restoration of an Effective Cough.DiMarco AF, Geertman RT, Tabbaa K, Polito RR, Kowalski KE. DiMarco AF, et al. Top Spinal Cord Inj Rehabil. 2017 Summer;23(3):271-278. doi: 10.1310/sci2303-271. Top Spinal Cord Inj Rehabil. 2017. PMID: 29339903 Free PMC article.
- Restoration of cough via spinal cord stimulation improves pulmonary function in tetraplegics.DiMarco AF, Geertman RT, Tabbaa K, Nemunaitis GA, Kowalski KE. DiMarco AF, et al. J Spinal Cord Med. 2020 Sep;43(5):579-585. doi: 10.1080/10790268.2019.1699678. Epub 2019 Dec 6. J Spinal Cord Med. 2020. PMID: 31809251 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 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.
- Narrative review of current neuromodulation modalities for spinal cord injury.Medina R, Ho A, Reddy R, Chen J, Castellanos J. Medina R, et al. Front Pain Res (Lausanne). 2023 Mar 9;4:1143405. doi: 10.3389/fpain.2023.1143405. eCollection 2023. Front Pain Res (Lausanne). 2023. PMID: 36969918 Free PMC article. Review.
- Regulation of Human Respiration by Electrical Stimulation.Shandybina ND, Kuropatenko MV, Moshonkina TR. Shandybina ND, et al. J Evol Biochem Physiol. 2022;58(6):1879-1891. doi: 10.1134/S0022093022060175. Epub 2022 Dec 22. J Evol Biochem Physiol. 2022. PMID: 36573159 Free PMC article.
- 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
- Comparison of disc and wire electrodes to restore cough via lower thoracic spinal cord stimulation.DiMarco AF, Geertman RT, Nemunaitis GA, Kowalski KE. DiMarco AF, et al. J Spinal Cord Med. 2022 May;45(3):354-363. doi: 10.1080/10790268.2021.1936388. Epub 2021 Jul 7. J Spinal Cord Med. 2022. PMID: 34232841 Free PMC article. Clinical Trial.
- Design and Testing of Stimulation and Myoelectric Recording Modules in an Implanted Distributed Neuroprosthetic System.Makowski N, Campean A, Lambrecht J, Buckett J, Coburn J, Hart R, Miller M, Montague F, Crish T, Fu M, Kilgore K, Peckham PH, Smith B. Makowski N, et al. IEEE Trans Biomed Circuits Syst. 2021 Apr;15(2):281-293. doi: 10.1109/TBCAS.2021.3066838. Epub 2021 May 25. IEEE Trans Biomed Circuits Syst. 2021. PMID: 33729949 Free PMC article.
- Adult
- Cohort Studies
- Cough / etiology*
- Cough / therapy*
- Electroconvulsive Therapy / methods*
- Female
- Humans
- Male
- Middle Aged
- Pulmonary Ventilation / physiology
- Respiratory Tract Infections / etiology
- Spinal Cord / physiology*
- Spinal Cord Injuries / complications*
- Time Factors
- Treatment Outcome
- Young Adult
- Full Text Sources
- Other Literature Sources
- Medical
- Miscellaneous
![Figure 5](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4116721/bin/scm-37-380.05.jpg)
Source: PubMed