NCT00116337

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2004

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

Study Start

First participant enrolled

September 30, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2005

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2017

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

April 13, 2020

Completed
Last Updated

May 4, 2020

Status Verified

April 1, 2020

Enrollment Period

13 years

First QC Date

June 28, 2005

Results QC Date

August 1, 2019

Last Update Submit

April 17, 2020

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)

  • 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)

Secondary Outcomes (2)

  • Incident of Acute Respiratory Tract Infections

    baseline (pre-implant) and 1 year follow up (post-implant)

  • Trained Caregiver Support for Secretion Clearance

    baseline (pre-implant) and 1 year follow up (post-implant)

Study Arms (1)

Expiratory Muscle Stimulator

EXPERIMENTAL

Procedure/Surgery: spinal cord stimulation to restore cough

Procedure: Spinal Cord Stimulation to restore coughDevice: Expiratory Muscle Stimulator

Interventions

Spinal Cord Stimulation to restore coughPROCEDURE

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.

Expiratory Muscle Stimulator
Expiratory Muscle StimulatorDEVICE

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.

Expiratory Muscle Stimulator

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable spinal cord injury T5 level or higher
  • Expiratory muscle weakness

You may not qualify if:

  • Significant cardiovascular disease
  • Active lung disease
  • Brain disease
  • Scoliosis, chest wall deformity, or marked obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (14)

  • 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

  • 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.

    PMID: 12015345BACKGROUND

  • 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, 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: 16543552RESULT

  • 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: 19406290RESULT

  • 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: 19406289RESULT

  • 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: 24090524RESULT

  • 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

  • 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: 34232841DERIVED

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
Dr. Anthony Dimarco
Organization
MetroHealth Medical Center
adimarco@metrohealth.org
216-778-3906

Study Officials

  • Anthony F. DiMarco, MD

    MetroHealth Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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 of Medicine

Study Record Dates

First Submitted

June 28, 2005

First Posted

June 29, 2005

Study Start

September 30, 2004

Primary Completion

October 10, 2017

Study Completion

October 31, 2017

Last Updated

May 4, 2020

Results First Posted

April 13, 2020

Record last verified: 2020-04

Locations

US(1)