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Spinal Cord Stimulation to Restore Cough
This study is currently recruiting participants.
Verified by National Institute of Neurological Disorders and Stroke (NINDS), March 2009
First Received: June 28, 2005   Last Updated: March 27, 2009   History of Changes
Sponsors and Collaborators: MetroHealth Medical Center
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00116337
  Purpose

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.


Condition Intervention
Spinal Cord Injuries
Spinal Cord Diseases
Paralysis
Central Nervous System Diseases
Cough
Trauma, Nervous System
Wounds and Injuries
Procedure: Implant and use of the device

MedlinePlus related topics: Cough Injuries Neurologic Diseases Paralysis Spinal Cord Diseases Spinal Cord Injuries Wounds
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Spinal Cord Stimulation to Restore Cough

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Primary Outcome Measures:
  • Measurements of airway pressure, expired volume and expiratory flow rate to evaluate efficacy of cough. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of need for caregiver support for secretion removal. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Assessment of ease in expectoration of secretions. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Incidence of respiratory tract infections. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: September 2004
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Procedure/Surgery: spinal cord stimulation
Procedure: Implant and use of the device
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.

Detailed Description:

Patients with cervical and thoracic 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 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 18 adults (18-70 years old) with spinal injuries (T5 level or higher), at least 12 months following the date of injury. After an evaluation of medical history, a brief physical examination, and initial testing, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Significant cardiovascular disease
  • Active lung disease
  • Brain disease
  • Scoliosis, chest wall deformity, or marked obesity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116337

Contacts
Contact: Dana R Hromyak, BS, RRT (216) 778-3612 dhromyak@metrohealth.org

Locations
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Dana R Hromyak, BS, RRT     216-778-3612     dhromyak@metrohealth.org    
Principal Investigator: Anthony F. DiMarco, MD            
Sponsors and Collaborators
MetroHealth Medical Center
Investigators
Principal Investigator: Anthony F. DiMarco, MD MetroHealth Medical Center
  More Information

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. Epub 2006 Mar 16.
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.
DiMarco AF, Romaniuk JR, Kowalski KE, Supinski G. Pattern of expiratory muscle activation during lower thoracic spinal cord stimulation. J Appl Physiol. 1999 Jun;86(6):1881-9.
DiMarco AF, Romaniuk JR, Kowalski KE, Supinski G. Mechanical contribution of expiratory muscles to pressure generation during spinal cord stimulation. J Appl Physiol. 1999 Oct;87(4):1433-9.
DiMarco AF, Kowalski KE, Supinski G, Romaniuk JR. Mechanism of expiratory muscle activation during lower thoracic spinal cord stimulation. J Appl Physiol. 2002 Jun;92(6):2341-6.
Romaniuk JR, Dick TE, Kowalski KE, Dimarco AF. Effects of pulse lung inflation on chest wall expiratory motor activity. J Appl Physiol. 2007 Jan;102(1):485-91. Epub 2006 Sep 7.
Kowalski KE, Romaniuk JR, DiMarco AF. Changes in expiratory muscle function following spinal cord section. J Appl Physiol. 2007 Apr;102(4):1422-8. 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. Epub 2007 Jun 22.
DiMarco AF, Kowalski KE. Effects of chronic electrical stimulation on paralyzed expiratory muscles. J Appl Physiol. 2008 Jun;104(6):1634-40. Epub 2008 Apr 10.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: MetroHealth Medical Center and Case Western Reserve University ( Anthony F. DiMarco, MD/Principal Investigator )
Study ID Numbers: R01NS049516, IRB 98-00091
Study First Received: June 28, 2005
Last Updated: March 27, 2009
ClinicalTrials.gov Identifier: NCT00116337     History of Changes
Health Authority: United States: Institutional Review Board of MetroHealth Medical Center;   United States: Food and Drug Administration;   United States: National Institutes of Health

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
spinal cord injury
paralysis
cough
cervical spinal cord injury
thoracic spinal cord injury

Study placed in the following topic categories:
Spinal Cord Diseases
Respiration Disorders
Wounds and Injuries
Cough
Central Nervous System Diseases
Disorders of Environmental Origin
Trauma, Nervous System
Paralysis
Spinal Cord Injuries
Signs and Symptoms
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Neurologic Manifestations

Additional relevant MeSH terms:
Spinal Cord Diseases
Nervous System Diseases
Respiration Disorders
Wounds and Injuries
Central Nervous System Diseases
Cough
Disorders of Environmental Origin
Trauma, Nervous System
Paralysis
Spinal Cord Injuries
Signs and Symptoms
Respiratory Tract Diseases
Neurologic Manifestations
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on May 07, 2009