Stimulation With Wire Leads to Restore Cough
The purpose of this trial is to determine the efficacy of spinal cord stimulation, using wire leads, to produce an effective cough in patients with spinal cord injuries.
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Device: Expiratory muscle stimulator
Procedure: Implantation of device
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Spinal Cord Stimulation With Wire Leads to Restore Cough|
- Measurements of peak expiratory airflow rate to evaluate efficacy of cough [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Measurements of maximum airway pressure to evaluate efficacy of cough [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Assessment of need for caregiver support for secretion management as measured by a caregiver burden inventory and quality of life survey [ Time Frame: 2 years ] [ Designated as safety issue: No ]Survey will assess time dependency, personal development, and physical, social, and emotional health of the caregiver, as well as assess specific need for caregiver's assistance in managing secretions.
- Assessment of ease in expectoration of secretions using a secretion management index [ Time Frame: 2 years ] [ Designated as safety issue: No ]Survey will assess difficulty, frequency, and severity of subject's secretion management.
- Incidence of respiratory tract infections using a form [ Time Frame: 2 years ] [ Designated as safety issue: No ]Form covers frequency, type, severity, and antibiotic use for respiratory tract infections.
- Assessment of quality of life as measured by the SCI QL-23 and quality of life surveys [ Time Frame: 2 years ] [ Designated as safety issue: No ]Survey will assess the subject's quality of life at home and in social situations, as well as assess specific need for managing secretions.
|Study Start Date:||April 2015|
|Estimated Study Completion Date:||August 2019|
|Estimated Primary Completion Date:||February 2019 (Final data collection date for primary outcome measure)|
Experimental: Procedure & Device
Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator
Device: Expiratory muscle stimulator
The expiratory muscle stimulator consists of two small electrodes (wire leads) implanted on the surface of the spinal cord 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.
Other Name: Custom Finetech/Ardiem Sacral Anterior Root StimulatorProcedure: Implantation of device
The expiratory muscle stimulator consists of two wire leads(each with two metal contacts) inserted onto the surface of their spinal cord on the lower back using a needle. The procedure to implant these wire leads is commonly used today for other purposes. This is a minimally invasive surgical technique with minimal risks. The wire leads 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 to stimulate the expiratory muscles and restore cough.
Patients with cervical 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. Expiratory muscles can be activated by electrical stimulation of the spinal roots to produce a functionally effective cough.
The purpose of this trial is to determine if electrical stimulation of the expiratory muscles by wire leads is capable of producing an effective cough on demand. According to the trial researchers, if successful, this technique will prevent the need for frequent patient suctioning — which often requires the constant presence of trained personnel. It will also allow spinal cord injured patients to clear their secretions more readily, thereby reducing the incidence of respiratory complications and associated illness and death.
In the trial, researchers will study 16 adults (18-75 years old) with cervical spinal injuries (C8 level or higher), at least 6 months following the date of injury. After an evaluation of medical history, a brief physical examination, and initial testing, participants will have wire leads placed — by a routine, minimally invasive surgical procedure — over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659541
|Contact: Rebecca R Riffle, MSfirstname.lastname@example.org|
|United States, Ohio|
|MetroHealth Medical Center||Recruiting|
|Cleveland, Ohio, United States, 44109|
|Contact: Rebecca R Riffle, MS 216-778-3612 email@example.com|
|Principal Investigator: Anthony F. DiMarco, MD|
|Principal Investigator:||Anthony F. DiMarcom, MD||MetroHealth Medical Center|