Stimulation With Wire Leads to Restore Cough
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|ClinicalTrials.gov Identifier: NCT01659541|
Recruitment Status : Recruiting
First Posted : August 8, 2012
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment|
|Spinal Cord Injuries Spinal Cord Diseases Paralysis Central Nervous System Diseases Cough Trauma, Nervous System Wounds and Injuries||Device: Expiratory muscle stimulator Procedure: Implantation of device|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Spinal Cord Stimulation With Wire Leads to Restore Cough|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||August 2019|
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.
- Measurements of peak expiratory airflow rate to evaluate efficacy of cough [ Time Frame: 2 years ]
- Measurements of maximum airway pressure to evaluate efficacy of cough [ Time Frame: 2 years ]
- 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 ]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 ]Survey will assess difficulty, frequency, and severity of subject's secretion management.
- Incidence of respiratory tract infections using a form [ Time Frame: 2 years ]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 ]Survey will assess the subject's quality of life at home and in social situations, as well as assess specific need for managing secretions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659541
|Contact: Theresa L Fallon, BAemail@example.com|
|United States, Ohio|
|MetroHealth Medical Center||Recruiting|
|Cleveland, Ohio, United States, 44109|
|Contact: Theresa L Fallon, BA 216-778-3612 firstname.lastname@example.org|
|Principal Investigator: Anthony F. DiMarco, MD|
|Principal Investigator:||Anthony F. DiMarco, MD||MetroHealth Medical Center|