Spinal cord injury is one of the most serious injuries the nervous system can sustain. Injuries involving the cervical region of the spinal cord result in quadriplegia, in which movement of the upper extremities is compromised, lower extremity movement is essentially impossible, and bowel, bladder, and respiratory functions are disrupted. An example of the many types of medical problems which accompany quadriplegia is the inability of the patient to clear his respiratory tract by coughing. Pulmonary complications frequently leading to premature death are, in part, a consequence of not being able to cough. This application proposes a feasibility study of electrical stimulation of the major muscles of expiration in order to produce a cough.
The specific aims are: 1. Replicate the production of electrically stimulated cough in quadriplegic individuals as reported in two recently published preliminary studies by two separate laboratories. Test the ability of presently available neuromuscular stimulators to produce such a cough. 2. Conduct preliminary clinical trials of this method of cough induction in a pulmonary function laboratory where complete quantitative assessment of a cough can be made. 3. Design and build a prototype device that produces a cough when activated (unassisted by a caregiver) by the quadriplegic individual. This device will be needed for the more comprehensive clinical trials to be undertaken in Phase II, and will be a marketable product for the company. 4. Prepare detailed protocols for the clinical evaluation of this device in Phase II.
