Spinal Cord Stimulation to Restore Cough

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anthony F. DiMarco, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00116337
First received: June 28, 2005
Last updated: May 23, 2012
Last verified: May 2012
  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: Spinal Cord Stimulation
Device: Expiratory Muscle Stimulator

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Spinal Cord Stimulation to Restore Cough

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

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: March 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Procedure/Surgery: spinal cord stimulation
Procedure: Spinal Cord Stimulation
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.
Device: Expiratory Muscle Stimulator
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.

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

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

Publications:

Responsible Party: Anthony F. DiMarco, Professor of Medicine, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00116337     History of Changes
Other Study ID Numbers: R01NS049516/RC1NS068576, IRB 98-00091, RC1NS068576
Study First Received: June 28, 2005
Last Updated: May 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Case Western Reserve University:
spinal cord injury
paralysis
cough
cervical spinal cord injury
thoracic spinal cord injury

Additional relevant MeSH terms:
Central Nervous System Diseases
Cough
Nervous System Diseases
Retinitis Pigmentosa
Spinal Cord Diseases
Spinal Cord Injuries
Wounds and Injuries
Paralysis
Trauma, Nervous System
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Eye Diseases, Hereditary
Eye Diseases
Retinal Dystrophies
Retinal Degeneration
Retinal Diseases
Genetic Diseases, Inborn
Neurologic Manifestations

ClinicalTrials.gov processed this record on April 15, 2014