Spinal Cord Stimulation to Restore Cough
NCT00116337 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2020-05-04
Summary
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.
Conditions
- Spinal Cord Injuries
- Spinal Cord Diseases
- Paralysis
- Central Nervous System Diseases
- Cough
- Trauma, Nervous System
- Wounds and Injuries
Interventions
- 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.
Sponsors & Collaborators
-
MetroHealth Medical Center
lead OTHER
Principal Investigators
-
Anthony F. DiMarco, MD · MetroHealth Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-09-30
- Primary Completion
- 2017-10-10
- Completion
- 2017-10-31
Countries
- United States
Study Locations
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