Functional Electrical Stimulation for Production of Artificial Cough

This study has been completed.
Sponsor:
Collaborator:
MetroHealth Medical Center
Information provided by (Responsible Party):
Anthony F. DiMarco, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00589199
First received: December 21, 2007
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

The purpose of the present study is to assess the utility of abdominal muscle stimulation to provide large positive airway pressures and expiratory airflow thus simulating cough. Restoration of cough in spinal cord injured patients may reduce the incidence of respiratory complications such as atelectasis, respiratory tract infections and respiratory failure.


Condition Intervention
Spinal Cord Injuries
Paralysis
Procedure: Placement and use of the device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Functional Electrical Stimulation for Production of Artificial Cough

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

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

Secondary Outcome Measures:
  • Incidence of respiratory complications [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: December 1993
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Procedure/Surgery: Surface electrodes will be applied to the abdominal wall and over the posterior lower thoracic rib cage.
Procedure: Placement and use of the device
Surface electrodes currently used for peripheral muscle stimulation by other groups will be applied to the abdominal wall and over the posterior lower thoracic rib cage. Between two and three pairs (anodic and cathodic) of electrodes will be used in combination to activate the expiratory muscles. Electrodes will be positioned at various points over the abdominal wall and the posterior thoracic rib cage to ascertain optimal placement for airway pressure and expiratory airflow generation. The electrical stimulators to be used (EMPI and NeuroMedic) are powered by 9-volt batteries. These stimulators are currently in clinical use to stimulate other skeletal muscles and are known to be quite safe.

Detailed Description:

Cough is a complex defensive respiratory reflex mechanism necessary for the clearance of respiratory secretions and foreign materials. In patients with chronic bronchitis, previous investigations have found that the cough mechanism is the most effective measure to enhance mucous clearance from the lung.

Patients with cervical and thoracic spinal cord injuries have suffered a loss of the major portion of their expiratory muscles. Consequently, they are unable to generate significant positive intrathoracic airway pressures or airflow and have a markedly increased risk of developing pulmonary infections. Mechanical methods have been developed to enhance cough production. However, these have resulted in only marginal increases in airway pressure.

Preliminary studies in our laboratory in animal experiments and those of others in humans have suggested that the abdominal muscles can be stimulated directly by surface electrodes. The purpose of the present study, therefore, is to assess the utility of abdominal muscle stimulation in quadriplegics and paraplegics to simulate cough. A range of stimulus parameters and electrode locations will be assessed to determine optimal stimulus paradigms. Airway pressure and expiratory airflow will be used as indices of cough effectiveness. If successful, abdominal muscle stimulation may be a useful tool to restore cough and hopefully reduce the incidence of respiratory complications such as atelectasis and infection in spinal cord injured patients.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with cervical or thoracic spinal cord injury

Exclusion Criteria:

  • Significant cardiovascular disease
  • Active lung disease
  • Pacemaker or other metallic implant
  • Legally incompetent
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00589199

Locations
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
Case Western Reserve University
MetroHealth Medical Center
Investigators
Principal Investigator: Anthony F DiMarco, MD MetroHealth Medical Center and Case Western Reserve University
  More Information

No publications provided

Responsible Party: Anthony F. DiMarco, Professor of Medicine, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00589199     History of Changes
Other Study ID Numbers: IRB93-00133
Study First Received: December 21, 2007
Last Updated: May 23, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Spinal Cord Injuries
Paralysis
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014