Spinal Cord Stimulation to Restore Cough

Spinal Cord Injuries Clinical Trial

Official title:

Spinal Cord Stimulation to Restore Cough

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116337
• Other study ID #: IRB98-00091
• Secondary ID: IRB 98-000912788
• Status: Completed
• Phase: N/A
• Start date: September 30, 2004
• Est. completion date: October 31, 2017

Study information

• Verified date: April 2020
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 31, 2017
• Est. primary completion date: October 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Diseases
• Cough
• Nervous System Diseases
• Paralysis
• Spinal Cord Diseases
• Spinal Cord Injuries
• Trauma, Nervous System
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (12)

DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR, Frost FS, Creasey GH, Nemunaitis GA. Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-Sponsored clinical trial. Part I — View Citation

DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR. Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-sponsored clinical trial. Part I: methodology and effectiveness of ex — View Citation

DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR. Spinal cord stimulation: a new method to produce an effective cough in patients with spinal cord injury. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1386-9. Epub 2006 Mar 16. — View Citation

DiMarco AF, Kowalski KE, Hromyak DR, Geertman RT. Long-term follow-up of spinal cord stimulation to restore cough in subjects with spinal cord injury. J Spinal Cord Med. 2014 Jul;37(4):380-8. doi: 10.1179/2045772313Y.0000000152. Epub 2013 Nov 26. — View Citation

DiMarco AF, Kowalski KE, Romaniuk JR. Effects of diaphragm activation on airway pressure generation during lower thoracic spinal cord stimulation. Respir Physiol Neurobiol. 2007 Oct 15;159(1):102-7. Epub 2007 Jun 22. — View Citation

DiMarco AF, Kowalski KE, Supinski G, Romaniuk JR. Mechanism of expiratory muscle activation during lower thoracic spinal cord stimulation. J Appl Physiol (1985). 2002 Jun;92(6):2341-6. — View Citation

DiMarco AF, Kowalski KE. Effects of chronic electrical stimulation on paralyzed expiratory muscles. J Appl Physiol (1985). 2008 Jun;104(6):1634-40. doi: 10.1152/japplphysiol.01321.2007. Epub 2008 Apr 10. — View Citation

DiMarco AF, Romaniuk JR, Kowalski KE, Supinski G. Mechanical contribution of expiratory muscles to pressure generation during spinal cord stimulation. J Appl Physiol (1985). 1999 Oct;87(4):1433-9. — View Citation

DiMarco AF, Romaniuk JR, Kowalski KE, Supinski G. Pattern of expiratory muscle activation during lower thoracic spinal cord stimulation. J Appl Physiol (1985). 1999 Jun;86(6):1881-9. — View Citation

DiMarco AF, Romaniuk JR, Supinski GS. Electrical activation of the expiratory muscles to restore cough. Am J Respir Crit Care Med. 1995 May;151(5):1466-71. — View Citation

Kowalski KE, Romaniuk JR, DiMarco AF. Changes in expiratory muscle function following spinal cord section. J Appl Physiol (1985). 2007 Apr;102(4):1422-8. Epub 2006 Dec 7. — View Citation

Romaniuk JR, Dick TE, Kowalski KE, Dimarco AF. Effects of pulse lung inflation on chest wall expiratory motor activity. J Appl Physiol (1985). 2007 Jan;102(1):485-91. Epub 2006 Sep 7. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of Expiratory Muscle Activation to Generate Large Airway Pressures Characteristic of Normal Cough.	Airway pressure generation achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).	baseline (pre-implant) and 1 year follow up (post-implant)
Primary	Effectiveness of Expiratory Muscle Activation to Generate High Peak Airflows Characteristic of Normal Cough.	Peak airflow achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).	baseline (pre-implant) and 1 year follow up (post-implant)
Secondary	Incident of Acute Respiratory Tract Infections	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.	baseline (pre-implant) and 1 year follow up (post-implant)
Secondary	Trained Caregiver Support for Secretion Clearance	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.	baseline (pre-implant) and 1 year follow up (post-implant)