Grant: $429,281 - National Institutes of Health - Sep. 25, 2009
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Award Description: This application addresses broad Challenge Area (06) Enabling Technologies and Specific Challenge Topic, 06-NS-104: Developing and validating assistive neuro-technologies. Respiratory complications account for significant morbidity and mortality in patients with spinal cord injury due to their inability to cough and clear secretions. These individuals lack an effective cough mechanism due to the fact that their injury often results in paralysis of virtually all of their expiratory muscles. Consequently, these patients are dependent upon caregiver assistance for the application of manual suctioning, assisted coughing maneuvers or other methods of airway management. These methods are cumbersome, generally uncomfortable, require trained personnel and often restrict patient mobility. In a single site, pilot study in tetraplegic subjects, we have recently shown that the expiratory muscles can be electrically activated by spinal cord stimulation. Disc electrodes are positioned in the dorsal epidural space at the lower thoracic and upper lumbar spinal levels through laminotomy incisions. The results of this study indicate that 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, this technique facilitates secretion removal, reduces the need for caregiver support, reduces the incidence of respiratory tract infections and improves life quality. This technique therefore has the potential to reduce health care costs and improve survival in spinal cord injured subjects. While successful, many individuals with spinal cord injury are reluctant to pursue this technique due to the invasive procedure required for electrode placement. It is our hypothesis however that comparable activation of the expiratory muscles can be achieved with wire electrodes which can be inserted percutaneously through a needle, eliminating the need for the invasive laminotomy procedure and can be performed on an out-patient basis. This latter procedure would increase patient and physician acceptance of this technique, shorten recovery times and significantly reduce costs. The purpose of this undertaking therefore is to directly compare the efficacy of wire electrodes vs the previously employed disc electrodes. In 6 patients undergoing permanent implantation of disc electrodes to restore cough, we plan to directly compare the degree of expiratory muscle activation achieved with temporary placement of several different wire electrode systems with the disc electrodes. The degree of expiratory muscle activation will be compared by monitoring the changes in airway pressure and peak airflow rate generation achieved during electrical stimulation with different electrode systems in the Operating Room. The results of this trial will provide a) critically important data concerning the size and stimulus configuration of wire electrodes resulting in optimal expiratory muscle activation, b) the framework for additional human studies utilizing minimally invasive techniques to restore cough and c) necessary data for a possible amendment of our Investigational Device Exemption (IDE) to restore cough via spinal cord stimulation, with regard to use of wire electrodes. PUBLIC HEALTH RELEVANCE: Due to their inability to cough, respiratory complications such as pneumonia are a major cause of disability and death in subjects with spinal cord injury. The purpose of the proposed study is to evaluate a minimally invasive method of electrical activation of the expiratory muscles to restore cough utilizing spinal cord wire electrodes which can be inserted percutaneously. This technique would likely have wide patient and physician acceptance, significantly reduce the need for caregiver support, facilitate management of respiratory secretions, reduce the incidence of respiratory tract infections, reduce costs and improve life quality in this patient population.
Project Description: Efforts are underway to recruit and enroll eligible participants in this study. Thus far, we have been in contact with 3 prospective participants who knew of our past work and have expressed a great interest in participating in his study. Our goal is to recruit, enroll and implant one participant with the investigational device by the close of the first full quarter (end date 12/31/2009). We have also begun efforts to locate and purchase necessary equipment to carry out this work.
Jobs Summary: Not Applicable (Total jobs reported: 0)
Project Status: Less Than 50% Completed
This award's data was last updated on Sep. 25, 2009. Help expand these official descriptions using the wiki below.