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Completed

NCT Number: NCT04179799

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 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UF Health - Jacksonville

Jacksonville, Florida, 32008, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diaphragm pacing

Device

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.

Primary outcomes

  1. Change in Electromyogram (EMG)

    Time frame: Baseline up to 24 hours

    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.

  2. Change in Maximal Inspiratory Pressure (MIP)

    Time frame: Baseline up to 24 hours

    The Maximum Inspiratory Pressure (MIP) is measured by a device that applies an inspiratory load which provides a resistance. The MIP will be measured in cmH20 and assesses diaphragm strength. MIP will be recorded will be recorded during non-stimulated respiration (diaphragm pacer turned off).

  3. Change in Tidal Volume

    Time frame: Baseline up to 24 hours

    The measurement of Tidal Volume is performed through a simple spirometry and is measured in liters. Tidal Volume will be recorded during non-stimulated respiration (diaphragm pacer turned off).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 27, 2019
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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