Overview

This trial is active, not recruiting.

Conditions spinal cord injuries, spinal cord diseases, paralysis, central nervous system diseases, cough
Treatments spinal cord stimulation, expiratory muscle stimulator
Sponsor Case Western Reserve University
Collaborator National Institute of Neurological Disorders and Stroke (NINDS)
Start date October 2009
End date January 2017
Trial size 6 participants
Trial identifier NCT00995215, IRB08-00269, IRB08-00269/IRB98-00091, IRB98-00091

Summary

Respiratory infections, such as pneumonia and bronchitis, occur frequently in the spinal cord injured population, due to paralysis of the muscles responsible for coughing. Using spinal cord stimulation techniques, these muscles can be activated to restore an effective cough mechanism.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
spinal cord stimulation NeuroControl Expiratory Muscle Stimulation (IDE G980267)
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.
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 Outcomes

Measure
Measurements of airway pressure, expired volume and expiratory flow rate to evaluate efficacy of cough.
time frame: one year

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Evaluation of Wire Electrodes to Activate the Expiratory Muscles to Restore Cough
Principal investigator Anthony F. DiMarco, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Case Western Reserve University.