CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6 enrolled
Drug / intervention
Diaphragm Pacingdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04179799
NCT04179799N/ACompleted

Diaphragm Stimulation After Human Spinal Cord Injury: Effects on Respiratory Neural Drive and Function

University of Florida·observational·Posted Nov 27, 2019·Updated May 30, 2024

In Brief

An observational study evaluating Diaphragm Pacing for Cervical Spinal Cord Injury. Completed, enrolled 6 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 27, 2019
Enrollment StartJan 10, 2020
Primary CompletionAug 20, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.6 years ago

Interventions

Diaphragm Pacingdevice

Intramuscular stimulation of the diaphragm, or diaphragm "pacing' is achieved by laparoscopic placement of stimulation wires into each hemidiaphragm. Phrenic motor points on the diaphragm are mapped to optimize electrode placement. The electrodes are threaded into the diaphragm muscle and wire leads are externalized and attached to a stimulation controller.