Stimulation With Wire Leads to Restore Cough

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Spinal Cord Stimulation With Wire Leads to Restore Cough

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

Intervention / Treatment
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* Device: Expiratory muscle stimulator
* Procedure: Implantation of device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spinal cord injury C8 level or higher 12 months post-injury (if the American Spinal Injury Association (ASIA) Impairment Scale (AIS) incomplete) or 6 months post-injury (if AIS complete) Expiratory muscle weakness Between 18 and 75 years of age Adequate oxygenation Exclusion Criteria: Untreated lung, cardiovascular or brain disease Scoliosis, chest wall deformity, or marked obesity Unmanaged hypertension (high blood pressure) or hypotension (low blood pressure) Low oxygenation Minor infection at the site of implantation requiring antibiotics within the past 3 weeks Serious infection requiring hospitalization within the past 6 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Procedure & Device<br>Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator | Device: Expiratory muscle stimulator<br>* 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.<br>* Other names: Custom Finetech/Ardiem Sacral Anterior Root Stimulator;Procedure: Implantation of device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough. | Peak Expiratory airflow rate is a person's maximum speed of expiration. Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration. It was measured after release of airway occlusion after peak airway pressure was achieved. | 52 weeks (1 year) | 
| Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough | Maximum expiratory pressure is the highest pressure that can be developed during a forceful expiratory effort against an occluded airway. | 52 weeks (1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secretion Management Episodes | This assessment allowed to characterize the severity of secretion management episodes and subjective assessment of the need for secretion management before and after use of the Cough System. Design: Prospective assessment via questionnaire responses Question: How significant were your needs for assistance with managing your airway secretions on a typical day during the past week? 0 None - Unaware of need Mild - Did not interfere with usual daily activities Moderate - Most stop activity during need Marked - Most stop activity for brief period (10-30 min) after need Severe - Most stop activity for prolonged period (> 30 min) after need, may be accompanied by dizziness, headache and/or pain in upper chest | 52 weeks (1 year) | 
| Difficulty Raising Sputum | Survey to assess difficulty raising sputum Objectives: To determine the difficulty raising sputum before and after use of the cough stimulation system (Cough System) Design: Prospective assessment via questionnaire responses Question: How much difficulty have you had with managing your airway secretions? On a scale of 0-4 (0 = None (No secretions), 1 = Mild (Rarely have difficulty), 2 = Moderate (Occasional difficulty) 3 = Marked (Frequent difficulty) and 4=Severe (Usually have great difficulty). | 52 weeks (1 year) | 
| Number of Respiratory Tract Infections | Form covers frequency, type, severity, and antibiotic use for respiratory tract infections. 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 before and after 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. | 52 weeks (1 year) | 
| Life Quality Assessment -Stress Level | Survey will assess the subject's quality of life at home and in social situations, as well as assess specific need for managing secretions. Objectives: Life Quality Assessment before and after use of the cough stimulation system (Cough System) Design: Prospective assessment via questionnaire responses Question: To what extent did managing your airway secretions cause you stress? On a scale of 0-3 (0 = Not at all, 1 = a little, 2 = Quite a bit and 3 = Very much) | 52 weeks (1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injury, paralysis, cough, cervical spinal cord injury, thoracic spinal cord injury