Spinal Cord Stimulation With Wire Leads to Restore Cough
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- MetroHealth Medical Center
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Anthony F. Dimarco
Professor
MetroHealth Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough.
Time Frame: 52 weeks (1 year)
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.
Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough
Time Frame: 52 weeks (1 year)
Maximum expiratory pressure is the highest pressure that can be developed during a forceful expiratory effort against an occluded airway.
Secondary Outcomes
- Secretion Management Episodes(52 weeks (1 year))
- Difficulty Raising Sputum(52 weeks (1 year))
- Life Quality Assessment -Stress Level(52 weeks (1 year))
- Number of Respiratory Tract Infections(52 weeks (1 year))