NCT01659541

Brief Summary

The purpose of this trial is to determine the efficacy of spinal cord stimulation, using wire leads, to produce an effective cough in patients with spinal cord injuries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 8, 2012

Completed
2.6 years until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 19, 2022

Completed
Last Updated

December 8, 2022

Status Verified

November 1, 2022

Enrollment Period

6.3 years

First QC Date

May 23, 2012

Results QC Date

May 18, 2022

Last Update Submit

November 11, 2022

Conditions

Spinal Cord InjuriesSpinal Cord DiseasesParalysisCentral Nervous System DiseasesCoughTrauma, Nervous SystemWounds and Injuries

Keywords

spinal cord injuryparalysiscoughcervical spinal cord injurythoracic spinal cord injury

Outcome Measures

Primary Outcomes (2)

  • Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough.

    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.

    52 weeks (1 year)

  • Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough

    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 Outcomes (4)

  • Secretion Management Episodes

    52 weeks (1 year)

  • Difficulty Raising Sputum

    52 weeks (1 year)

  • Number of Respiratory Tract Infections

    52 weeks (1 year)

  • Life Quality Assessment -Stress Level

    52 weeks (1 year)

Study Arms (1)

Procedure & Device

EXPERIMENTAL

Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator

Device: Expiratory muscle stimulatorProcedure: Implantation of device

Interventions

Expiratory muscle stimulatorDEVICE

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.

Also known as: Custom Finetech/Ardiem Sacral Anterior Root Stimulator
Procedure & Device
Implantation of devicePROCEDURE

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.

Procedure & Device

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spinal cord injury C8 level or higher
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (22)

  • 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.

    PMID: 16543552BACKGROUND

  • 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.

    PMID: 19406290BACKGROUND

  • 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.

    PMID: 19406289BACKGROUND

  • 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.

    PMID: 22330116BACKGROUND

  • 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.

    PMID: 7735601BACKGROUND

  • 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.

    PMID: 10368352BACKGROUND

  • 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.

    PMID: 10517775BACKGROUND

  • 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.

    PMID: 1201534BACKGROUND

  • 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.

    PMID: 16959914BACKGROUND

  • 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.

    PMID: 17158247BACKGROUND

  • 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.

    PMID: 17681870BACKGROUND

  • 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.

    PMID: 18403449BACKGROUND

  • 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.

    PMID: 24090524BACKGROUND

  • 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.

    PMID: 29339903BACKGROUND

  • 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.

    PMID: 29017400BACKGROUND

  • 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.

    PMID: 30119089BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 31688014BACKGROUND

  • 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.

    PMID: 31809251BACKGROUND

  • 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.

    PMID: 33161007BACKGROUND

  • 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.

    PMID: 34232841BACKGROUND

  • 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.

    PMID: 37017634DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesSpinal Cord DiseasesParalysisCentral Nervous System DiseasesCoughTrauma, Nervous SystemWounds and Injuries

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, Respiratory

Results Point of Contact

Title
Anthony F. DiMarco, MD
Organization
MetroHealth Medical Center
afd3@case.edu
216-778-3906

Study Officials

  • Anthony F. DiMarco, MD

    MetroHealth Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 23, 2012

First Posted

August 8, 2012

Study Start

April 1, 2015

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

December 8, 2022

Results First Posted

August 19, 2022

Record last verified: 2022-11

Locations

US(1)