N/A
N=17
Spinal Cord Stimulation to Restore Cough
Spinal Cord Injuries · Spinal Cord Diseases · Paralysis · Central Nervous System Diseases · Cough
Bottom Line
View on ClinicalTrials.gov: NCT00116337 ↗Enrolled (actual)
17
Serious AEs
5.9%
Results posted
Apr 2020
Primary outcome: Primary: Effectiveness of Expiratory Muscle Activation to Generate Large Airway Pressures Characteristic of Normal Cough. — 25; 121 cmH2O — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Spinal Cord Stimulation to restore cough (Procedure); Expiratory Muscle Stimulator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MetroHealth Medical Center
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effectiveness of Expiratory Muscle Activation to Generate Large Airway Pressures Characteristic of Normal Cough. |
25; 121 | <0.05 sig |
| PRIMARY Effectiveness of Expiratory Muscle Activation to Generate High Peak Airflows Characteristic of Normal Cough. |
1.9; 7.7 | — |
| SECONDARY Incident of Acute Respiratory Tract Infections |
1.31; 0.29 | <0.05 sig |
| SECONDARY Trained Caregiver Support for Secretion Clearance |
23.4; 7.7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00116337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.