Stimulation With Wire Leads to Restore Cough

November 11, 2022 updated by: Anthony F. Dimarco, MetroHealth Medical Center

Spinal Cord Stimulation With Wire Leads to Restore Cough

The purpose of this trial is to determine the efficacy of spinal cord stimulation, using wire leads, to produce an effective cough in patients with spinal cord injuries.

Study Overview

Detailed Description

Patients with cervical 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 by wire leads 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 16 adults (18-75 years old) with cervical spinal injuries (C8 level or higher), at least 6 months following the date of injury. After an evaluation of medical history, a brief physical examination, and initial testing, participants will have wire leads placed - by a routine, minimally invasive surgical procedure - over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Spinal cord injury C8 level or higher
  • 12 months post-injury (if the American Spinal Injury Association (ASIA) Impairment Scale (AIS) incomplete) or 6 months post-injury (if AIS complete)
  • Expiratory muscle weakness
  • Between 18 and 75 years of age
  • Adequate oxygenation

Exclusion Criteria:

  • Untreated lung, cardiovascular or brain disease
  • Scoliosis, chest wall deformity, or marked obesity
  • Unmanaged hypertension (high blood pressure) or hypotension (low blood pressure)
  • Low oxygenation
  • Minor infection at the site of implantation requiring antibiotics within the past 3 weeks
  • Serious infection requiring hospitalization within the past 6 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Procedure & Device
Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator
The expiratory muscle stimulator consists of two small electrodes (wire leads) implanted on the surface of the spinal cord 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.
Other Names:
  • Custom Finetech/Ardiem Sacral Anterior Root Stimulator
The expiratory muscle stimulator consists of two wire leads(each with two metal contacts) inserted onto the surface of their spinal cord on the lower back using a needle. The procedure to implant these wire leads is commonly used today for other purposes. This is a minimally invasive surgical technique with minimal risks. The wire leads 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 to stimulate the expiratory muscles and restore cough.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough.
Time Frame: 52 weeks (1 year)
Peak Expiratory airflow rate is a person's maximum speed of expiration. Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration. It was measured after release of airway occlusion after peak airway pressure was achieved.
52 weeks (1 year)
Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough
Time Frame: 52 weeks (1 year)
Maximum expiratory pressure is the highest pressure that can be developed during a forceful expiratory effort against an occluded airway.
52 weeks (1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secretion Management Episodes
Time Frame: 52 weeks (1 year)

This assessment allowed to characterize the severity of secretion management episodes and subjective assessment of the need for secretion management before and after use of the Cough System.

Design: Prospective assessment via questionnaire responses

Question: How significant were your needs for assistance with managing your airway secretions on a typical day during the past week?

0 None - Unaware of need

  1. Mild - Did not interfere with usual daily activities
  2. Moderate - Most stop activity during need
  3. Marked - Most stop activity for brief period (10-30 min) after need
  4. Severe - Most stop activity for prolonged period (> 30 min) after need, may be accompanied by dizziness, headache and/or pain in upper chest
52 weeks (1 year)
Difficulty Raising Sputum
Time Frame: 52 weeks (1 year)

Survey to assess difficulty raising sputum

Objectives: To determine the difficulty raising sputum before and after use of the cough stimulation system (Cough System)

Design: Prospective assessment via questionnaire responses

Question: How much difficulty have you had with managing your airway secretions?

On a scale of 0-4 (0 = None (No secretions), 1 = Mild (Rarely have difficulty), 2 = Moderate (Occasional difficulty) 3 = Marked (Frequent difficulty) and 4=Severe (Usually have great difficulty).

52 weeks (1 year)
Number of Respiratory Tract Infections
Time Frame: 52 weeks (1 year)

Form covers frequency, type, severity, and antibiotic use for 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 before and after 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.

52 weeks (1 year)
Life Quality Assessment -Stress Level
Time Frame: 52 weeks (1 year)

Survey will assess the subject's quality of life at home and in social situations, as well as assess specific need for managing secretions.

Objectives: Life Quality Assessment before and after use of the cough stimulation system (Cough System)

Design: Prospective assessment via questionnaire responses

Question: To what extent did managing your airway secretions cause you stress? On a scale of 0-3 (0 = Not at all, 1 = a little, 2 = Quite a bit and 3 = Very much)

52 weeks (1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anthony F. DiMarco, MD, MetroHealth Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

May 23, 2012

First Submitted That Met QC Criteria

August 3, 2012

First Posted (Estimate)

August 8, 2012

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

November 11, 2022

Last Verified

November 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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