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Diaphragm Pacing in Individuals With Spinal Cord Injuries

NCT04179799 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6

Last updated 2024-05-30

Study results available
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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.

Conditions

  • Cervical Spinal Cord Injury

Interventions

DEVICE

Diaphragm Pacing

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Emily Fox, PT, PhD · University of Florida

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-10
Primary Completion
2022-08-20
Completion
2022-08-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04179799 on ClinicalTrials.gov