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NCT04179799 · ClinicalTrials.gov registry record

Diaphragm Pacing in Individuals With Spinal Cord Injuries

A clinical trial, sponsored by University of Florida.

Completed
Registry status
6
Enrollment target

NCT04179799: Completed study, sponsored by University of Florida.

NCT04179799 is a clinical trial that has completed, run by University of Florida. The registered enrollment target is 6 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04179799 has completed, sponsored by University of Florida.

COMPLETED
Registry status
6 participants
Enrollment target

Study 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.

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.

Interventions

  • DEVICE Diaphragm Pacing

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2020-01-10
Est. Completion 2022-08-20
University of Florida

1,106 total trials

What the finished NCT04179799 record still lists

NCT04179799 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 6 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Diaphragm Pacing is the first listed.

NCT04179799 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04179799 about?

NCT04179799 is a clinical study titled "Diaphragm Pacing in Individuals With Spinal Cord Injuries". 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 ...

What is the current status of trial NCT04179799?

This trial is currently completed. The enrollment target is 6 participants. The study started on 2020-01-10. Estimated completion is 2022-08-20.

What interventions are being tested in trial NCT04179799?

The interventions under investigation include: Diaphragm Pacing (DEVICE).

Who is sponsoring clinical trial NCT04179799?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04179799, the US trial registry maintained by the National Library of Medicine. NCT04179799 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.