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: October 2, 2014
Last verified: October 2014

June 28, 2005
October 2, 2014
September 2004
January 2017   (final data collection date for primary outcome measure)
Measurements of airway pressure, expired volume and expiratory flow rate to evaluate efficacy of cough. [ Time Frame: one year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00116337 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Spinal Cord Stimulation to Restore Cough
Spinal Cord Stimulation to Restore Cough

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Spinal Cord Injuries
  • Spinal Cord Diseases
  • Paralysis
  • Central Nervous System Diseases
  • Cough
  • Trauma, Nervous System
  • Wounds and Injuries
  • 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.
Experimental: 1
Procedure/Surgery: spinal cord stimulation
Interventions:
  • Procedure: Spinal Cord Stimulation
  • Device: Expiratory Muscle Stimulator

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
18
June 2017
January 2017   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00116337
278855, IRB 98-00091, 278855
Yes
Anthony F. DiMarco, Case Western Reserve University
Case Western Reserve University
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Anthony F. DiMarco, MD MetroHealth Medical Center
Case Western Reserve University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP