Clinical trial NCT04179799: Diaphragm Pacing in Individuals With Spinal Cord Injuries
Official title: Diaphragm Stimulation After Human Spinal Cord Injury: Effects on Respiratory Neural Drive and Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Spinal Cord Injury
Keywords: SCI
diaphragm pacing
respiratory impairment
diaphragm stimulation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-11-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute, traumatic C-SCIs, scheduled to receive intramuscular diaphragm pacing OR who have recently received a diaphragm pacer (within past 5-days) will be recruited from UF Health Shands Jacksonville, a Level-1 trauma hospital serving North Florida.

Brief 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.

Detailed description: Respiratory dysfunction is a 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. This study will assess the effects of diaphragm stimulation on respiratory neural drive and breathing function in individuals with acute, traumatic C-SCI. Recording from these surgically implanted electrodes allows comparisons of electromyogram (EMG) recordings, in association with respiratory assessments, before and after short periods of diaphragm pacing to isolate the unique contribution of diaphragm pacing on neuromuscular diaphragm activation.

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

Primary outcomes:
measure: Change in Electromyogram (EMG)
timeFrame: Baseline up to 24 hours
measure: Change in Maximal Inspiratory Pressure (MIP)
timeFrame: Baseline up to 24 hours
measure: Change in Tidal Volume
timeFrame: Baseline up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: UF Health - Jacksonville
state: Florida
Study officials:
affiliation: University of Florida
name: Emily Fox, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: