N/A
Completed N=6
Diaphragm Pacing in Individuals With Spinal Cord Injuries
Source: ClinicalTrials.gov NCT04179799 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Change in Electromyogram (EMG) — -.0031 mV
Summary
This project will evaluate the effects of intramuscular diaphragm stimulation (pacing) and test the hypothesis that diaphragm pacing enhances neuromuscular diaphragm activation and respiratory function in adults with cervical spinal cord injuries (C-SCIs). The investigators will test the hypothesis by recording activity of the diaphragm from intramuscular pacing electrodes and conduct respiratory assessments in adults with intramuscular diaphragm pacing electrodes following acute, traumatic C-SCIs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Electromyogram (EMG) |
-.0031 | — |
| PRIMARY Change in Maximal Inspiratory Pressure (MIP) |
.27 | — |
| PRIMARY Change in Tidal Volume |
.02 | — |
Eligibility Criteria
Inclusion Criteria
- Acute, traumatic cervical spinal cord injuries (C-SCIs), classified according to the American Spinal Injury Association (ASIA) Impairment Scale (AIS) as A-C
- Scheduled to undergo implantation of a diaphragm pacer, or who have recently received (in past 5-days) implantation of intramuscular diaphragm pacing electrodes due to severe respiratory impairments and dependence on mechanical ventilation
Exclusion Criteria
- Progressive neuromuscular diseases such as multiple sclerosis and myasthenia gravis
- History of neurologic injuries such as stroke or prior SCI
- Chest wall injuries or deformities likely to influence breathing
- Pregnancy
- Cognitive impairments limiting study participation
Data sourced from ClinicalTrials.gov (NCT04179799). 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. Informational only — not medical advice.