Spinal Cord Stimulation to Restore Cough
The purpose of this trial is to determine the efficacy of spinal cord stimulation 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
Procedure: Spinal Cord Stimulation
Device: Expiratory Muscle Stimulator
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Spinal Cord Stimulation to Restore Cough|
- Measurements of airway pressure, expired volume and expiratory flow rate to evaluate efficacy of cough. [ Time Frame: one year ] [ Designated as safety issue: No ]
- Assessment of need for caregiver support for secretion removal. [ Time Frame: one year ] [ Designated as safety issue: No ]
- Assessment of ease in expectoration of secretions. [ Time Frame: one year ] [ Designated as safety issue: No ]
- Incidence of respiratory tract infections. [ Time Frame: one year ] [ Designated as safety issue: No ]
|Study Start Date:||September 2004|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Procedure/Surgery: spinal cord stimulation
Procedure: Spinal Cord Stimulation
Participants will have small electrodes (metal discs) placed — by a routine surgical procedure — over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are then activated at subsequent study visits using the external control unit.Device: 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.
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. 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 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 18 adults (18-70 years old) with spinal injuries (T5 level or higher), at least 12 months following the date of injury. After an evaluation of medical history, a brief physical examination, and initial testing, participants will have small electrodes (metal discs) placed — by a routine surgical procedure — over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough.
|United States, Ohio|
|MetroHealth Medical Center|
|Cleveland, Ohio, United States, 44109|
|Principal Investigator:||Anthony F. DiMarco, MD||MetroHealth Medical Center|