Trial Outcomes & Findings for Spinal Cord Stimulation to Restore Cough (NCT NCT00116337)
NCT ID: NCT00116337
Last Updated: 2020-05-04
Results Overview
Airway pressure generation achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).
COMPLETED
NA
17 participants
baseline (pre-implant) and 1 year follow up (post-implant)
2020-05-04
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 |
Clinical Trial - Spinal Cord Stimulation to Restore Cough
Design: Clinical trial. Participants: Subjects with cervical spinal cord injury and weak cough. Interventions: A fully implantable electrical stimulation system was surgically placed in each subject.
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|---|---|
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Overall Study
STARTED
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17
|
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Overall Study
COMPLETED
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17
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spinal Cord Stimulation to Restore Cough
Baseline characteristics by cohort
| Measure |
Clinical Trial - Spinal Cord Stimulation Cough System
n=17 Participants
Design: Clinical trial.
Participants: Subjects with cervical spinal cord injury and weak cough.
Interventions: A fully implantable electrical stimulation system was surgically placed in each subject.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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17 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=99 Participants
|
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Sex: Female, Male
Female
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3 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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14 Participants
n=99 Participants
|
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Race/Ethnicity, Customized
Caucasian
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15 participants
n=99 Participants
|
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Race/Ethnicity, Customized
Black or African American
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2 participants
n=99 Participants
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PRIMARY outcome
Timeframe: baseline (pre-implant) and 1 year follow up (post-implant)Population: Male - 14; Female - 3
Airway pressure generation achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).
Outcome measures
| Measure |
Pre-Implant - Spontaneous Effort
n=17 Participants
Airway pressure generation during spontaneous efforts.
|
Post-Implantation - Spinal Cord Stimulation (SCS)
n=17 Participants
Changes in airway pressure generation during SCS at the 1-year follow-up.
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|---|---|---|
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Effectiveness of Expiratory Muscle Activation to Generate Large Airway Pressures Characteristic of Normal Cough.
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25 cmH2O
Standard Error 3
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121 cmH2O
Standard Error 14
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PRIMARY outcome
Timeframe: baseline (pre-implant) and 1 year follow up (post-implant)Population: Male - 14; Female - 3
Peak airflow achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).
Outcome measures
| Measure |
Pre-Implant - Spontaneous Effort
n=17 Participants
Airway pressure generation during spontaneous efforts.
|
Post-Implantation - Spinal Cord Stimulation (SCS)
n=17 Participants
Changes in airway pressure generation during SCS at the 1-year follow-up.
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|---|---|---|
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Effectiveness of Expiratory Muscle Activation to Generate High Peak Airflows Characteristic of Normal Cough.
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1.9 L/s
Standard Error 0.2
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7.7 L/s
Standard Error 0.9
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SECONDARY outcome
Timeframe: baseline (pre-implant) and 1 year follow up (post-implant)Population: Male - 14; Female - 3
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 over the 2-year period prior to 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. After implantation of the cough system, the incidence of acute respiratory tract infections was tracked continually.
Outcome measures
| Measure |
Pre-Implant - Spontaneous Effort
n=17 Participants
Airway pressure generation during spontaneous efforts.
|
Post-Implantation - Spinal Cord Stimulation (SCS)
n=17 Participants
Changes in airway pressure generation during SCS at the 1-year follow-up.
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|---|---|---|
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Incident of Acute Respiratory Tract Infections
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1.31 Intections per year
Standard Error 0.32
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0.29 Intections per year
Standard Error 0.11
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SECONDARY outcome
Timeframe: baseline (pre-implant) and 1 year follow up (post-implant)Population: Male - 14; Female - 3
The degree of caregiver support was determined as the number of times it was necessary for a caregiver to provide the subject with any form of assistive means of secretion clearance including suctioning, manually assisted cough or use of the insufflation-exsufflation device. Caregiver support was evaluated over a 2-week period prior to implantation of the cough stimulation system and continuously over the course of the initial year and again at the 1-year follow-up.
Outcome measures
| Measure |
Pre-Implant - Spontaneous Effort
n=17 Participants
Airway pressure generation during spontaneous efforts.
|
Post-Implantation - Spinal Cord Stimulation (SCS)
n=17 Participants
Changes in airway pressure generation during SCS at the 1-year follow-up.
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|---|---|---|
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Trained Caregiver Support for Secretion Clearance
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23.4 times/week
Standard Error 7.3
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7.7 times/week
Standard Error 4.1
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Adverse Events
Post-Implantation - Spinal Cord Stimulation (SCS)
Serious adverse events
| Measure |
Post-Implantation - Spinal Cord Stimulation (SCS)
n=17 participants at risk
Hemodynamic effects: Increases in blood pressure in association with the initial application of SCS.
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|---|---|
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Infections and infestations
Infection
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5.9%
1/17 • Number of events 1 • 5 year follow up (post-implant)
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Other adverse events
| Measure |
Post-Implantation - Spinal Cord Stimulation (SCS)
n=17 participants at risk
Hemodynamic effects: Increases in blood pressure in association with the initial application of SCS.
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|---|---|
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Nervous system disorders
Hemodynamic effects: Decreases in pulse rate
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17.6%
3/17 • Number of events 3 • 5 year follow up (post-implant)
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place