Trial Outcomes & Findings for Stimulation With Wire Leads to Restore Cough (NCT NCT01659541)
NCT ID: NCT01659541
Last Updated: 2022-12-08
Results Overview
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.
COMPLETED
NA
12 participants
52 weeks (1 year)
2022-12-08
Participant Flow
Subjects were well informed of the details of the study, with particular interest to risks/benefits, and asked to review the Informed Consent before signing. They were given an opportunity to ask questions. Consent was obtained only after all questions and concerns have been addressed.
Participant milestones
| Measure |
Spinal Cord Stimulation With Wire Leads to Restore Cough
Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator
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.
Implantation of device: 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.
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|---|---|
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A medical implant (cough system) has been removed (explanted ) from one participant due to increase in frequency and severity of spasms.
Baseline characteristics by cohort
| Measure |
Clinical Trial: Spinal Cord Stimulation to Restore Cough
n=12 Participants
Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator
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.
Implantation of device: 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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=12 Participants
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Age, Categorical
Between 18 and 65 years
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12 Participants
n=12 Participants
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Age, Categorical
>=65 years
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0 Participants
n=12 Participants
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Sex: Female, Male
Female
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0 Participants
n=12 Participants
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Sex: Female, Male
Male
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12 Participants
n=12 Participants
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Race/Ethnicity, Customized
Caucasian
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12 Participants
n=12 Participants
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Region of Enrollment
United States
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12 participants
n=12 Participants
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Pre-Implant - Spontaneous Effort - Airway Pressure
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24.7 cmH2O
STANDARD_DEVIATION 12.9 • n=11 Participants • A medical implant (cough system) has been removed (explanted ) from one participant due to increase in frequency and severity of spasms.
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Peak Expiratory Airflow Rate (L/s)
n=11 Participants
Each patient was served as their own control (Pre-Implant); comparisons were made at various points in the study (Week #28, #40 and #52).
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Number of Respiratory Tract Infections: Post-Implant - After Use of the Cough System (Week #52)
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 use of the Cough System.
The occurrence of respiratory tract infections was determined by subject history and corroborated by review of medical records, when available.
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|---|---|---|
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Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough.
Pre-Implant - Spontaneous Effort
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2.1 L/s
Standard Error 0.4
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—
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Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough.
Post-Implantation Week #28
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9.6 L/s
Standard Error 1.2
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—
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Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough.
Post-Implantation Week #40
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10.4 L/s
Standard Error 1.3
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—
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Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough.
Post-Implantation Week #52
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11.1 L/s
Standard Error 1.6
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—
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PRIMARY outcome
Timeframe: 52 weeks (1 year)Maximum expiratory pressure is the highest pressure that can be developed during a forceful expiratory effort against an occluded airway.
Outcome measures
| Measure |
Peak Expiratory Airflow Rate (L/s)
n=11 Participants
Each patient was served as their own control (Pre-Implant); comparisons were made at various points in the study (Week #28, #40 and #52).
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Number of Respiratory Tract Infections: Post-Implant - After Use of the Cough System (Week #52)
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 use of the Cough System.
The occurrence of respiratory tract infections was determined by subject history and corroborated by review of medical records, when available.
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Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough
Pre-Implant -Spontaneous Effort
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25 cmH2O
Standard Error 4
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—
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Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough
Post-Implantation Week #28
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112 cmH2O
Standard Error 13
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—
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Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough
Post-Implantation Week #40
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117 cmH2O
Standard Error 14
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—
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Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough
Post-Implantation Week #52
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118 cmH2O
Standard Error 14
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—
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SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Peak Expiratory Airflow Rate (L/s)
n=11 Participants
Each patient was served as their own control (Pre-Implant); comparisons were made at various points in the study (Week #28, #40 and #52).
|
Number of Respiratory Tract Infections: Post-Implant - After Use of the Cough System (Week #52)
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 use of the Cough System.
The occurrence of respiratory tract infections was determined by subject history and corroborated by review of medical records, when available.
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Secretion Management Episodes
Pre-Implant
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2.73 score on a scale
Standard Error 0.41
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—
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Secretion Management Episodes
Post-Implantation Week #28
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0.45 score on a scale
Standard Error 0.21
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—
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Secretion Management Episodes
Post-Implantation Week #40
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0.55 score on a scale
Standard Error 0.21
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—
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Secretion Management Episodes
Post-Implantation Week #52
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0.45 score on a scale
Standard Error 0.21
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—
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SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Peak Expiratory Airflow Rate (L/s)
n=11 Participants
Each patient was served as their own control (Pre-Implant); comparisons were made at various points in the study (Week #28, #40 and #52).
|
Number of Respiratory Tract Infections: Post-Implant - After Use of the Cough System (Week #52)
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 use of the Cough System.
The occurrence of respiratory tract infections was determined by subject history and corroborated by review of medical records, when available.
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Difficulty Raising Sputum
Pre-Implantation
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2.64 score on a scale
Standard Error 0.41
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—
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Difficulty Raising Sputum
Post-Implantation Week #28
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0.64 score on a scale
Standard Error 0.24
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—
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Difficulty Raising Sputum
Post-Implantation Week #40
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0.55 score on a scale
Standard Error 0.21
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—
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Difficulty Raising Sputum
Post-Implantation Week #52
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0.36 score on a scale
Standard Error 0.20
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—
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Peak Expiratory Airflow Rate (L/s)
n=11 Participants
Each patient was served as their own control (Pre-Implant); comparisons were made at various points in the study (Week #28, #40 and #52).
|
Number of Respiratory Tract Infections: Post-Implant - After Use of the Cough System (Week #52)
n=11 Participants
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 use of the Cough System.
The occurrence of respiratory tract infections was determined by subject history and corroborated by review of medical records, when available.
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|---|---|---|
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Number of Respiratory Tract Infections
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1.5 Respiratory tract infections per year
Standard Error 0.6
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0.1 Respiratory tract infections per year
Standard Error 0.1
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SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Peak Expiratory Airflow Rate (L/s)
n=11 Participants
Each patient was served as their own control (Pre-Implant); comparisons were made at various points in the study (Week #28, #40 and #52).
|
Number of Respiratory Tract Infections: Post-Implant - After Use of the Cough System (Week #52)
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 use of the Cough System.
The occurrence of respiratory tract infections was determined by subject history and corroborated by review of medical records, when available.
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|---|---|---|
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Life Quality Assessment -Stress Level
Pre-Implantation
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2.27 score on a scale
Standard Error 0.24
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—
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Life Quality Assessment -Stress Level
Post-Implantation Week #28
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0.18 score on a scale
Standard Error 0.18
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—
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Life Quality Assessment -Stress Level
Post-Implantation Week #40
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0.18 score on a scale
Standard Error 0.18
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—
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Life Quality Assessment -Stress Level
Post-Implantation Week #52
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0.27 score on a scale
Standard Error 0.27
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—
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Adverse Events
Post-Implantation; Spinal Cord Stimulation With Wire Leads to Restore Cough
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Post-Implantation; Spinal Cord Stimulation With Wire Leads to Restore Cough
n=12 participants at risk
Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator
The expiratory muscle stimulator (Cough System) 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.
Use of the spinal cord stimulation (SCS) Cough System was associated with some side effects, most notably increases in blood pressure and decreases in heart rate, consistent with autonomic dysreflexia (AD). AD was limited to the early phase of SCS and occurred in a total of 6 subjects. Over a period of several weeks of daily SCS however, this response gradually abated and eventually resolved in each subject. Mild back and leg jerking without associated discomfort was also observed in some subjects. This effect was well controlled by reducing the intensity of SCS.
There was no evidence of bowel or bladder leakage.
The Cough System have had to be explanted in one participant due increase in frequency and severity of muscle spasm.
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Nervous system disorders
Hemodynamic effect - Initial increases in blood pressure and decreases in heart rate
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50.0%
6/12 • Number of events 6 • 2 years
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Nervous system disorders
Muscle spasm
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8.3%
1/12 • Number of events 1 • 2 years
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place