Stimulation With Wire Leads to Restore Cough

Not Applicable

Completed

• Conditions: Paralysis; Wounds and Injuries; Spinal Cord Diseases; Trauma, Nervous System; Spinal Cord Injuries; Cough; Central Nervous System Diseases
• Interventions: Device: Expiratory muscle stimulator; Procedure: Implantation of device

• Registration Number: NCT01659541
• Lead Sponsor: MetroHealth Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2012-05-23
• Study First Submitted QC: 2012-08-03
• Study First Posted: 2012-08-08
• Study Start: 2015-04
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Results First Submitted: 2022-05-18
• Results First Submitted QC: 2022-07-26
• Results First Posted: 2022-08-19
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-11
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Procedure & Device	Expiratory muscle stimulator	Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator
Procedure & Device	Implantation of device	Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator

Primary Outcome Measures

Name	Time	Method
Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough.	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.
Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough	52 weeks (1 year)	Maximum expiratory pressure is the highest pressure that can be developed during a forceful expiratory effort against an occluded airway.

Secondary Outcome Measures

Name	Time	Method
Difficulty Raising Sputum	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).
Secretion Management Episodes	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
Life Quality Assessment -Stress Level	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)
Number of Respiratory Tract Infections	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.

Trial Locations

Locations (1)

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States