Stimulation With Wire Leads to Restore Cough

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Case Western Reserve University
Sponsor:
Collaborators:
MetroHealth Medical Center
Information provided by (Responsible Party):
Anthony F. DiMarco, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01659541
First received: May 23, 2012
Last updated: April 23, 2015
Last verified: April 2015
  Purpose

The purpose of this trial is to determine the efficacy of spinal cord stimulation, using wire leads, 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
Device: Expiratory muscle stimulator
Procedure: Implantation of device

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 With Wire Leads to Restore Cough

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Measurements of peak expiratory airflow rate to evaluate efficacy of cough [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Measurements of maximum airway pressure to evaluate efficacy of cough [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of need for caregiver support for secretion management as measured by a caregiver burden inventory and quality of life survey [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Survey will assess time dependency, personal development, and physical, social, and emotional health of the caregiver, as well as assess specific need for caregiver's assistance in managing secretions.

  • Assessment of ease in expectoration of secretions using a secretion management index [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Survey will assess difficulty, frequency, and severity of subject's secretion management.

  • Incidence of respiratory tract infections using a form [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Form covers frequency, type, severity, and antibiotic use for respiratory tract infections.

  • Assessment of quality of life as measured by the SCI QL-23 and quality of life surveys [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Survey will assess the subject's quality of life at home and in social situations, as well as assess specific need for managing secretions.


Estimated Enrollment: 16
Study Start Date: April 2015
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Procedure & Device
Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator
Device: Expiratory muscle stimulator
The expiratory muscle stimulator consists of two small electrodes (wire leads) implanted on the surface of the spinal cord 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.
Other Name: Custom Finetech/Ardiem Sacral Anterior Root Stimulator
Procedure: Implantation of device
The expiratory muscle stimulator consists of two wire leads(each with two metal contacts) inserted onto the surface of their spinal cord on the lower back using a needle. The procedure to implant these wire leads is commonly used today for other purposes. This is a minimally invasive surgical technique with minimal risks. The wire leads 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 to stimulate the expiratory muscles and restore cough.

Detailed Description:

Patients with cervical 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 by wire leads 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 16 adults (18-75 years old) with cervical spinal injuries (C8 level or higher), at least 6 months following the date of injury. After an evaluation of medical history, a brief physical examination, and initial testing, participants will have wire leads placed — by a routine, minimally invasive 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 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Spinal cord injury C8 level or higher
  • 12 months post-injury (if AIS incomplete) or 6 months post-injury (if AIS complete)
  • Expiratory muscle weakness
  • Between 18 and 75 years of age
  • Adequate oxygenation

Exclusion Criteria:

  • Untreated lung, cardiovascular or brain disease
  • Scoliosis, chest wall deformity, or marked obesity
  • Unmanaged hypertension (high blood pressure) or hypotension (low blood pressure)
  • Low oxygenation
  • Minor infection at the site of implantation requiring antibiotics within the past 3 weeks
  • Serious infection requiring hospitalization within the past 6 weeks
  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: NCT01659541

Contacts
Contact: Rebecca R Riffle, MS 216-778-3612 rriffle@metrohealth.org

Locations
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Rebecca R Riffle, MS    216-778-3612    rriffle@metrohealth.org   
Principal Investigator: Anthony F. DiMarco, MD         
Sponsors and Collaborators
Case Western Reserve University
MetroHealth Medical Center
Investigators
Principal Investigator: Anthony F. DiMarcom, MD MetroHealth Medical Center
  More Information

Publications:

Responsible Party: Anthony F. DiMarco, Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01659541     History of Changes
Other Study ID Numbers: IRB 15-00014, U01NS083696
Study First Received: May 23, 2012
Last Updated: April 23, 2015
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board
United States: Institutional Review Board

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
Paralysis
Spinal Cord Diseases
Spinal Cord Injuries
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on August 30, 2015