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Sponsors and Collaborators: |
MetroHealth Medical Center National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00116337 |
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.
Condition | Intervention |
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Spinal Cord Injuries Spinal Cord Diseases Paralysis Central Nervous System Diseases Cough Trauma, Nervous System Wounds and Injuries |
Procedure: Implant and use of the device |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Spinal Cord Stimulation to Restore Cough |
Estimated Enrollment: | 18 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Procedure/Surgery: spinal cord stimulation
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Procedure: Implant and use of the device
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.
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dana R Hromyak, BS, RRT | (216) 778-3612 | dhromyak@metrohealth.org |
United States, Ohio | |
MetroHealth Medical Center | Recruiting |
Cleveland, Ohio, United States, 44109 | |
Contact: Dana R Hromyak, BS, RRT 216-778-3612 dhromyak@metrohealth.org | |
Principal Investigator: Anthony F. DiMarco, MD |
Principal Investigator: | Anthony F. DiMarco, MD | MetroHealth Medical Center |
Responsible Party: | MetroHealth Medical Center and Case Western Reserve University ( Anthony F. DiMarco, MD/Principal Investigator ) |
Study ID Numbers: | R01NS049516, IRB 98-00091 |
Study First Received: | June 28, 2005 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00116337 History of Changes |
Health Authority: | United States: Institutional Review Board of MetroHealth Medical Center; United States: Food and Drug Administration; United States: National Institutes of Health |
spinal cord injury paralysis cough cervical spinal cord injury thoracic spinal cord injury |
Spinal Cord Diseases Respiration Disorders Wounds and Injuries Cough Central Nervous System Diseases Disorders of Environmental Origin Trauma, Nervous System |
Paralysis Spinal Cord Injuries Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms, Respiratory Neurologic Manifestations |
Spinal Cord Diseases Nervous System Diseases Respiration Disorders Wounds and Injuries Central Nervous System Diseases Cough Disorders of Environmental Origin |
Trauma, Nervous System Paralysis Spinal Cord Injuries Signs and Symptoms Respiratory Tract Diseases Neurologic Manifestations Signs and Symptoms, Respiratory |