This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Sub-study to Spinal Cord Stimulation to Restore Cough

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Anthony F. DiMarco, Case Western Reserve University.
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Anthony F. DiMarco, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00995215
First received: October 14, 2009
Last updated: April 20, 2015
Last verified: April 2015
  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: Intervention Model: Single Group Assignment
Masking: None (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 Anthony F. DiMarco, 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 ]

Secondary Outcome Measures:
  • Assessment of need for caregiver support for secretion removal. [ Time Frame: one year ]
  • Assessment of ease in expectoration of secretions. [ Time Frame: one year ]
  • Incidence of respiratory tract infections. [ Time Frame: one year ]

Estimated Enrollment: 6
Study Start Date: October 2009
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: January 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   (Adult, Senior)
Sexes Eligible for Study:   All
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
National Institute of Neurological Disorders and Stroke (NINDS)
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 ( Other Identifier: IRB )
IRB98-00091 ( Other Identifier: IRB )
Study First Received: October 14, 2009
Last Updated: April 20, 2015

Keywords provided by Anthony F. DiMarco, Case Western Reserve University:
spinal cord injury
SCI
paralysis
cough
cervical spinal cord injury
thoracic spinal cord injury

Additional relevant MeSH terms:
Cough
Spinal Cord Injuries
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 August 21, 2017