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NCT02556125 · ClinicalTrials.gov registry record
Diaphragm Pacing After Spinal Cord Injury
A clinical trial, sponsored by University of Florida.
- Completed
- Registry status
- 16
- Enrollment target
NCT02556125: Completed study, sponsored by University of Florida.
NCT02556125 is a clinical trial that has completed, run by University of Florida. The registered enrollment target is 16 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02556125 has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- 16 participants
- Enrollment target
Study Summary
Respiratory dysfunction is the leading cause of death in individuals with spinal cord injuries (SCIs). Nearly one quarter of all SCI cases involve injury to the upper spinal cord segments which impairs neural activation of the diaphragm muscle and compromises breathing. Although mechanical ventilation can be life-saving after cervical SCI (C-SCI), it also triggers rapid and profound diaphragm muscle atrophy, thereby complicating (or even preventing) ventilator weaning. Intramuscular diaphragm stimulation, or diaphragm pacing, was developed to replace long-term ventilator support, and is now used acutely post C-SCI (\<4 months following injury) to promote ventilator weaning. The impact of diaphragm pacing on respiratory function and diaphragm muscle activation has not been formally evaluated. This is an essential step in determining the efficacy of intramuscular diaphragm stimulation and its effects on respiratory function after SCI. Accordingly, this research study will evaluate the effects of intramuscular diaphragm stimulation and test the hypothesis that diaphragm pacing enhances neuromuscular diaphragm activation and respiratory function in adults with cervical SCIs. The investigators will test the hypothesis by evaluating the effects of diaphragm pacing on neuromuscular activation of the diaphragm by directly recording electromyogram (EMG) activity from the intramuscular pacing electrodes. Recording from these surgically-implanted electrodes allows direct comparisons of EMG activity across time, minimizing methodological limitations inherent with surface or percutaneous EMG recordings. This approach, in association with respiratory assessments, will be used to investigate the impact of diaphragm pacing in adults with intramuscular diaphragm pacing electrodes following acute, traumatic C-SCIs.
Primary Outcome
Neuromuscular activation of the diaphragm will be assessed by recording diaphragm EMGs from the surgically-implanted intramuscular stimulating electrodes. This approach will allow for comparisons of EMG recordings across time. EMGs will be recorded during non-stimulated respiration (diaphragm pacer turned off) and simultaneously with assessments of respiratory function. A Friedman's ANOVA will be used to test for differences in the EMG outcomes across the multiple (4 or more) time points. Post-h
Interventions
- DEVICE Diaphragm pacing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-12 |
| Est. Completion | 2020-08-11 |
What the finished NCT02556125 record still lists
NCT02556125 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 16 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Diaphragm pacing is the first listed.
NCT02556125 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02556125 about?
NCT02556125 is a clinical study titled "Diaphragm Pacing After Spinal Cord Injury". Respiratory dysfunction is the leading cause of death in individuals with spinal cord injuries (SCIs). Nearly one quarter of all SCI cases involve injury to the upper spinal cord segments which impairs neural activation of the diaphragm muscle and compromises breathing. Although mechanical ventilati...
What is the current status of trial NCT02556125?
This trial is currently completed. The enrollment target is 16 participants. The study started on 2015-12. Estimated completion is 2020-08-11.
What interventions are being tested in trial NCT02556125?
The interventions under investigation include: Diaphragm pacing (DEVICE).
Who is sponsoring clinical trial NCT02556125?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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