Restoration of Cough
Stimulation With Wire Leads to Restore Cough
Individuals with cervical and thoracic spinal cord injuries often experience paralysis of their expiratory muscles resulting in their inability to generate an effective cough mechanism. As a consequence, these individuals are prone to the development of respiratory tract infections, such as pneumonia and bronchitis, a major cause of death in this population.
An effective cough system can be implemented through restorative electrical stimulation techniques (e.g., spinal cord stimulation) resulting in greater ease in raising secretions and clearing the throat, a reduction in the incidence of respiratory tract infections, reduced need for caregiver support for secretion management, and greater mobility.
Through a recently conducted clinical trial using spinal cord stimulation with disc electrodes for expiratory muscle activation (http://clinicaltrials.gov/ct2/show/NCT00116337), each subject was able to produce an effective cough. There was a significant improvement in ease in raising secretions, reduction in the incidence of respiratory tract infections, reduced need for caregiver support, and improvement in overall quality of life. Additional benefits include enhanced mobility and improvement in overall life quality. While this technique was successful in restoring an effective cough in each subject, this method required an invasive surgical procedure.
About This Study
Objective/Specific Aims: The purpose of this new clinical trial is to determine if a new minimally invasive method of electrical stimulation of the expiratory muscles is also capable of producing an effective cough, on demand.
The goal of this project is to implement an effective, more natural cough using a system that can be independently operated by the user. This program is for individuals with a cervical level spinal cord injury and secondary impaired or ineffective cough, due to paralysis of the expiratory muscles. The system can be programmed to provide cough of varying intensity – to best meet the particular needs of each individual.
Study Information: Through a minimally invasive surgical procedure, 16 adults with cervical spinal injuries (C8 level or higher), at least 6 months following the date of injury, will receive wire leads placed over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough.
Detailed program information and criteria available at:
|Principal Investigator:||Anthony F DiMarco, M.D.|
|Contact Number:||(216) 791-3800 x5264|