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Spinal Cord Stimulation to Restore Cough

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00116337
Recruitment Status : Completed
First Posted : June 29, 2005
Results First Posted : April 13, 2020
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Anthony F. Dimarco, MetroHealth Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Spinal Cord Diseases Paralysis Central Nervous System Diseases Cough Trauma, Nervous System Wounds and Injuries Procedure: Spinal Cord Stimulation to restore cough Device: Expiratory Muscle Stimulator Not Applicable

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. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spinal Cord Stimulation to Restore Cough
Actual Study Start Date : September 30, 2004
Actual Primary Completion Date : October 10, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: Expiratory Muscle Stimulator
Procedure/Surgery: spinal cord stimulation to restore cough
Procedure: Spinal Cord Stimulation to restore cough
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.




Primary Outcome Measures :
  1. Effectiveness of Expiratory Muscle Activation to Generate Large Airway Pressures Characteristic of Normal Cough. [ Time Frame: baseline (pre-implant) and 1 year follow up (post-implant) ]
    Airway pressure generation achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).

  2. Effectiveness of Expiratory Muscle Activation to Generate High Peak Airflows Characteristic of Normal Cough. [ Time Frame: baseline (pre-implant) and 1 year follow up (post-implant) ]
    Peak airflow achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).


Secondary Outcome Measures :
  1. Incident of Acute Respiratory Tract Infections [ Time Frame: baseline (pre-implant) and 1 year follow up (post-implant) ]
    The incidence of acute respiratory tract infections, defined by a change in the character, color, or amount of respiratory secretions and requiring antibiotic administration was tracked over the 2-year period prior to implantation of the cough system. The occurrence of respiratory tract infections was determined by subject history and corroborated by review of medical records, when available. After implantation of the cough system, the incidence of acute respiratory tract infections was tracked continually.

  2. Trained Caregiver Support for Secretion Clearance [ Time Frame: baseline (pre-implant) and 1 year follow up (post-implant) ]
    The degree of caregiver support was determined as the number of times it was necessary for a caregiver to provide the subject with any form of assistive means of secretion clearance including suctioning, manually assisted cough or use of the insufflation-exsufflation device. Caregiver support was evaluated over a 2-week period prior to implantation of the cough stimulation system and continuously over the course of the initial year and again at the 1-year follow-up.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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): NCT00116337


Locations
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United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
Investigators
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Principal Investigator: Anthony F. DiMarco, MD MetroHealth Medical Center
  Study Documents (Full-Text)

Documents provided by Anthony F. Dimarco, MetroHealth Medical Center:
Study Protocol  [PDF] June 27, 2011
Statistical Analysis Plan  [PDF] June 27, 2011
Informed Consent Form  [PDF] June 27, 2011


Publications of Results:
Other Publications:
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Responsible Party: Anthony F. Dimarco, Professor of Medicine, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00116337    
Other Study ID Numbers: IRB98-00091
IRB 98-00091
278855 ( Other Grant/Funding Number: Neilsen Foundation )
First Posted: June 29, 2005    Key Record Dates
Results First Posted: April 13, 2020
Last Update Posted: May 4, 2020
Last Verified: April 2020
Keywords provided by Anthony F. Dimarco, MetroHealth Medical Center:
spinal cord injury
paralysis
cough
cervical spinal cord injury
thoracic spinal cord injury
Additional relevant MeSH terms:
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Cough
Spinal Cord Injuries
Paralysis
Central Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Neurologic Manifestations