Spinal Cord Stimulation to Restore Cough

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Institute of Neurological Disorders and Stroke (NINDS)

Information provided by (Responsible Party):

Anthony F. DiMarco, Case Western Reserve University

ClinicalTrials.gov Identifier:

NCT00116337

First received: June 28, 2005

Last updated: May 23, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 28, 2005

Last Updated Date

May 23, 2012

Start Date ^ICMJE

September 2004

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Measurements of airway pressure, expired volume and expiratory flow rate to evaluate efficacy of cough. [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00116337 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assessment of need for caregiver support for secretion removal. [ Time Frame: one year ] [ Designated as safety issue: No ]
Assessment of ease in expectoration of secretions. [ Time Frame: one year ] [ Designated as safety issue: No ]
Incidence of respiratory tract infections. [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Spinal Cord Stimulation to Restore Cough

Official Title ^ICMJE

Spinal Cord Stimulation to Restore Cough

Brief 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.

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Procedure: 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.
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.

Study Arm (s)

Experimental: 1

Procedure/Surgery: spinal cord stimulation

Interventions:

Procedure: Spinal Cord Stimulation
Device: Expiratory Muscle Stimulator

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2013

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00116337

Other Study ID Numbers ^ICMJE

R01NS049516/RC1NS068576, IRB 98-00091, RC1NS068576

Has Data Monitoring Committee

Yes

Responsible Party

Anthony F. DiMarco, Case Western Reserve University

Study Sponsor ^ICMJE

Case Western Reserve University

Collaborators ^ICMJE

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators ^ICMJE

Principal Investigator:

Anthony F. DiMarco, MD

MetroHealth Medical Center

Information Provided By

Case Western Reserve University

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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