Overview

This trial is active, not recruiting.

Conditions spinal cord injuries, spinal cord diseases, paralysis, central nervous system diseases, cough, trauma, nervous system, wounds and injuries
Treatments spinal cord stimulation, expiratory muscle stimulator
Sponsor Case Western Reserve University
Collaborator National Institute of Neurological Disorders and Stroke (NINDS)
Start date September 2004
End date January 2017
Trial size 18 participants
Trial identifier NCT00116337, 278855, IRB 98-00091, IRB98-00091

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Procedure/Surgery: spinal cord stimulation
spinal cord stimulation
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.
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.

Primary Outcomes

Measure
Measurements of airway pressure, expired volume and expiratory flow rate to evaluate efficacy of cough.
time frame: one year

Secondary Outcomes

Measure
Assessment of need for caregiver support for secretion removal.
time frame: one year
Assessment of ease in expectoration of secretions.
time frame: one year
Incidence of respiratory tract infections.
time frame: one year

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Spinal Cord Stimulation to Restore Cough
Principal investigator Anthony F. DiMarco, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Case Western Reserve University.