Evaluation of Wire Electrodes to Activate the Expiratory Muscles 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:
NCT00995215
First received: October 14, 2009
Last updated: October 2, 2014
Last verified: October 2014
  Purpose

Respiratory infections, such as pneumonia and bronchitis, occur frequently in the spinal cord injured population, due to paralysis of the muscles responsible for coughing. Using spinal cord stimulation techniques, these muscles can be activated to restore an effective cough mechanism.


Condition Intervention
Spinal Cord Injuries
Spinal Cord Diseases
Paralysis
Central Nervous System Diseases
Cough
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: Evaluation of Wire Electrodes to Activate the Expiratory Muscles 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: 6
Study Start Date: October 2009
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spinal Cord Stimulation
The participant will have wire electrodes temporarily placed - by a routine surgical procedure - over the surface of the spinal cord on the lower back. These electrodes will be activated in the operating room and the degree of muscle activation assessed. The wire electrodes will then be removed. Small, disc electrodes will then be permanently implanted to stimulate expiratory muscles and restore cough. These electrodes are activated using an external control unit.
Procedure: Spinal Cord Stimulation
The participant will have wire electrodes temporarily placed - by a routine surgical procedure - over the surface of the spinal cord on the lower back. These electrodes will be activated in the operating room and the degree of muscle activation assessed. The wire electrodes will then be removed. Small, disc electrodes will then be permanently implanted to stimulate expiratory muscles and restore cough. These electrodes are activated using an external control unit.
Other Name: NeuroControl Expiratory Muscle Stimulation (IDE G980267)
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. In fact, pneumonia is a major cause of death in this patient population.

In a recent clinical trial, we have shown that the expiratory muscles can be electrically activated by spinal cord stimulation (SCS), a technique which involves the surgical placement of disc electrodes on the surface of the spinal cord. This method is successful in achieving an effective means of expiratory muscle activation, as demonstrated by the generation of large airway pressures and peak airflow rates. Importantly, SCS facilitates secretion removal, reduces the need for caregiver support, reduces the incidence of respiratory tract infections and improves life quality. This method therefore has the potential to reduce health care costs and improve survival in spinal cord injured subjects.

The purpose of this trial is to directly compare activation of the expiratory muscles using wire electrodes, which can be inserted percutaneously through a needle, with the previously employed disc electrodes.

In this trial, researchers will study 6 adults (18-70 years old) with spinal injuries (T5 level or higher), at least 12 months following the date of injury. After an evaluation including medical history, a brief physical examination, and initial testing, each participant will undergo a surgical procedure to implant small electrodes (metal discs) over the surface of the spinal cord on the lower back to stimulate the expiratory muscles and restore cough. Prior to permanent implantation of this system, wire and disc electrodes will be compared by assessing the degree of expiratory muscle activation with each electrode type. The disc electrodes will then be permanently implanted, allowing the participant to have use of a fully functioning stimulation system to restore an effective 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995215

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 Case Western Reserve University
  More Information

Publications:
Responsible Party: Anthony F. DiMarco, Professor of Medicine, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00995215     History of Changes
Other Study ID Numbers: IRB08-00269/IRB98-00091, IRB08-00269, IRB98-00091, U01NS083696
Study First Received: October 14, 2009
Last Updated: October 2, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 16, 2014