N/A
N=12
Stimulation With Wire Leads to Restore Cough
Spinal Cord Injuries · Spinal Cord Diseases · Paralysis · Central Nervous System Diseases · Cough
Bottom Line
View on ClinicalTrials.gov: NCT01659541 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough. — 2.1; 9.6; 10.4; 11.1 L/s — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Expiratory muscle stimulator (Device); Implantation of device (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MetroHealth Medical Center
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough. |
2.1; 9.6; 10.4; 11.1 | <0.05 sig |
| PRIMARY Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough |
25; 112; 117; 118 | <0.05 sig |
| SECONDARY Secretion Management Episodes |
2.73; 0.45; 0.55; 0.45 | <0.05 sig |
| SECONDARY Difficulty Raising Sputum |
2.64; 0.64; 0.55; 0.36 | <0.05 sig |
| SECONDARY Number of Respiratory Tract Infections |
1.5; 0.1 | <0.05 sig |
| SECONDARY Life Quality Assessment -Stress Level |
2.27; 0.18; 0.18; 0.27 | <0.05 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01659541). 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.