Spinal Cord Stimulation to Restore Cough

Not Applicable

Completed

Conditions: Spinal Cord Diseases
Paralysis
Trauma, Nervous System
Spinal Cord Injuries
Central Nervous System Diseases
Wounds and Injuries
Cough

Interventions: Procedure: Spinal Cord Stimulation to restore cough
Device: Expiratory Muscle Stimulator

Registration Number: NCT00116337

Lead Sponsor: MetroHealth Medical Center

Brief Summary: 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.

Detailed 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. 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 17

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Expiratory Muscle Stimulator	Spinal Cord Stimulation to restore cough	Procedure/Surgery: spinal cord stimulation to restore cough
Expiratory Muscle Stimulator	Expiratory Muscle Stimulator	Procedure/Surgery: spinal cord stimulation to restore cough

Primary Outcome Measures

Name	Time	Method
Effectiveness of Expiratory Muscle Activation to Generate High Peak Airflows Characteristic of Normal Cough.	baseline (pre-implant) and 1 year follow up (post-implant)	Peak airflow achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).
Effectiveness of Expiratory Muscle Activation to Generate Large Airway Pressures Characteristic of Normal Cough.	baseline (pre-implant) and 1 year follow up (post-implant)	Airway pressure generation achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).

Secondary Outcome Measures

Name	Time	Method
Incident of Acute Respiratory Tract Infections	baseline (pre-implant) and 1 year follow up (post-implant)	The incidence of acute respiratory tract infections, defined by a change in the character, color, or amount of respiratory secretions and requiring antibiotic administration was tracked over the 2-year period prior to implantation of the cough system. The occurrence of respiratory tract infections was determined by subject history and corroborated by review of medical records, when available. After implantation of the cough system, the incidence of acute respiratory tract infections was tracked continually.
Trained Caregiver Support for Secretion Clearance	baseline (pre-implant) and 1 year follow up (post-implant)	The degree of caregiver support was determined as the number of times it was necessary for a caregiver to provide the subject with any form of assistive means of secretion clearance including suctioning, manually assisted cough or use of the insufflation-exsufflation device. Caregiver support was evaluated over a 2-week period prior to implantation of the cough stimulation system and continuously over the course of the initial year and again at the 1-year follow-up.