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Stimulation With Wire Leads to Restore Cough

This study is currently recruiting participants.
Verified January 2016 by Anthony F. DiMarco, Case Western Reserve University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01659541
First Posted: August 8, 2012
Last Update Posted: February 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
MetroHealth Medical Center
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Anthony F. DiMarco, Case Western Reserve University
  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: Intervention Model: Single Group Assignment
Masking: None (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 Anthony F. DiMarco, Case Western Reserve University:

Primary Outcome Measures:
  • Measurements of peak expiratory airflow rate to evaluate efficacy of cough [ Time Frame: 2 years ]
  • Measurements of maximum airway pressure to evaluate efficacy of cough [ Time Frame: 2 years ]

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 ]
    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 ]
    Survey will assess difficulty, frequency, and severity of subject's secretion management.

  • Incidence of respiratory tract infections using a form [ Time Frame: 2 years ]
    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 ]
    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

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659541


Contacts
Contact: Rebecca R Polito, MS 216-778-3612 rpolito@metrohealth.org

Locations
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Rebecca R Polito, MS    216-778-3612    rpolito@metrohealth.org   
Principal Investigator: Anthony F. DiMarco, MD         
Sponsors and Collaborators
Case Western Reserve University
MetroHealth Medical Center
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Anthony F. DiMarco, 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 ( U.S. NIH Grant/Contract )
First Submitted: May 23, 2012
First Posted: August 8, 2012
Last Update Posted: February 1, 2016
Last Verified: January 2016

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

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