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Functional Electrical Stimulation for Production of Artificial Cough
This study is ongoing, but not recruiting participants.
Sponsored by: MetroHealth Medical Center
Information provided by: MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00589199
  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

MedlinePlus related topics: Cough Paralysis Spinal Cord Injuries
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Parallel Assignment
Official Title: Functional Electrical Stimulation for Production of Artificial Cough

Further study details as provided by MetroHealth Medical Center:

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 ]

Estimated Enrollment: 30
Study Start Date: December 1993
Estimated Study Completion Date: August 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Procedure/Surgery: surface electrical stimulation
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
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
MetroHealth Medical Center
Investigators
Principal Investigator: Anthony F DiMarco, MD MetroHealth Medical Center and Case Western Reserve University
  More Information

Responsible Party: MetroHealth Medical Center and Case Western Reserve University ( Anthony F. DiMarco, MD/Principal Investigator )
Study ID Numbers: IRB93-00133
Study First Received: December 21, 2007
Last Updated: December 21, 2007
ClinicalTrials.gov Identifier: NCT00589199  
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009