Spinal Cord Stimulation to Restore Cough
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| ClinicalTrials.gov Identifier: NCT00116337 |
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Recruitment Status :
Completed
First Posted : June 29, 2005
Results First Posted : April 13, 2020
Last Update Posted : May 4, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Spinal Cord Injuries Spinal Cord Diseases Paralysis Central Nervous System Diseases Cough Trauma, Nervous System Wounds and Injuries | Procedure: Spinal Cord Stimulation to restore cough Device: Expiratory Muscle Stimulator | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 17 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Spinal Cord Stimulation to Restore Cough |
| Actual Study Start Date : | September 30, 2004 |
| Actual Primary Completion Date : | October 10, 2017 |
| Actual Study Completion Date : | October 31, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Expiratory Muscle Stimulator
Procedure/Surgery: spinal cord stimulation to restore cough
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Procedure: Spinal Cord Stimulation to restore cough
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. Device: Expiratory Muscle Stimulator The expiratory muscle stimulator consists of three small electrodes (metal discs) implanted over the surface of their spinal cords 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. |
- Effectiveness of Expiratory Muscle Activation to Generate Large Airway Pressures Characteristic of Normal Cough. [ Time Frame: 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).
- Effectiveness of Expiratory Muscle Activation to Generate High Peak Airflows Characteristic of Normal Cough. [ Time Frame: 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).
- Incident of Acute Respiratory Tract Infections [ Time Frame: 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 [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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): NCT00116337
| United States, Ohio | |
| MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| Principal Investigator: | Anthony F. DiMarco, MD | MetroHealth Medical Center |
Documents provided by Anthony F. Dimarco, MetroHealth Medical Center:
Other Publications:
| Responsible Party: | Anthony F. Dimarco, Professor of Medicine, MetroHealth Medical Center |
| ClinicalTrials.gov Identifier: | NCT00116337 |
| Other Study ID Numbers: |
IRB98-00091 IRB 98-00091 278855 ( Other Grant/Funding Number: Neilsen Foundation ) |
| First Posted: | June 29, 2005 Key Record Dates |
| Results First Posted: | April 13, 2020 |
| Last Update Posted: | May 4, 2020 |
| Last Verified: | April 2020 |
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spinal cord injury paralysis cough cervical spinal cord injury thoracic spinal cord injury |
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Cough Spinal Cord Injuries Nervous System Diseases Paralysis Central Nervous System Diseases Spinal Cord Diseases |
Trauma, Nervous System Wounds and Injuries Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Neurologic Manifestations |