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Sub-study to Spinal Cord Stimulation to Restore Cough

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ClinicalTrials.gov Identifier: NCT00995215
Recruitment Status : Completed
First Posted : October 15, 2009
Results First Posted : April 14, 2020
Last Update Posted : April 14, 2020
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Anthony F. Dimarco, MetroHealth Medical Center

Tracking Information
First Submitted Date  ICMJE October 14, 2009
First Posted Date  ICMJE October 15, 2009
Results First Submitted Date  ICMJE July 31, 2019
Results First Posted Date  ICMJE April 14, 2020
Last Update Posted Date April 14, 2020
Study Start Date  ICMJE October 2009
Actual Primary Completion Date October 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2020)
The Effects of Electrical Spinal Cord Stimulation (SCS) on Airway Pressure Generation While Using Temporarily Placed Parallel Wire Leads and Implanted Disc Electrodes [ Time Frame: intra-operative ]
The effects of SCS with temporarily placed parallel wire leads and then with permanently implanted disc electrodes on airway pressure generation in each participant was evaluated in the operating room. The wire electrodes were temporarily placed (immediately prior to placement of disc electrodes as part of the current clinical trial) over the surface of the spinal cord on the lower back. These electrodes were activated, and the degree of expiratory muscle activation were assessed. The wire electrodes were then removed. Small, disc electrodes were then permanently implanted to stimulate expiratory muscles and restore cough. All measurements were repeated. Since SCS with the disc electrode leads, when applied in clinical trials, resulted in airway pressure generation that approximated pressures generated with a normal maximum cough, airway pressure generation achieved during SCS with these leads served as our gold standard to which all comparisons were made.
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2009)
Measurements of airway pressure, expired volume and expiratory flow rate to evaluate efficacy of cough. [ Time Frame: one year ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2009)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sub-study to Spinal Cord Stimulation to Restore Cough
Official Title  ICMJE Evaluation of Wire Electrodes to Activate the Expiratory Muscles to Restore Cough
Brief Summary Evaluation of Wire Electrodes to Activate the Expiratory Muscles to Restore Cough
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Injuries
  • Spinal Cord Diseases
  • Paralysis
  • Central Nervous System Diseases
  • Cough
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Procedure: Spinal Cord Stimulation
  • Device: Expiratory Muscle Stimulator
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2009)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 31, 2017
Actual Primary Completion Date October 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00995215
Other Study ID Numbers  ICMJE IRB08-00269/IRB98-00091
IRB08-00269 ( Other Identifier: IRB )
IRB98-00091 ( Other Identifier: IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anthony F. Dimarco, MetroHealth Medical Center
Study Sponsor  ICMJE MetroHealth Medical Center
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Anthony F. DiMarco, MD Case Western Reserve University
PRS Account MetroHealth Medical Center
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP