Diaphragm Pacing in Individuals With Spinal Cord Injuries

Cervical Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04179799
• Other study ID #: IRB201902285
• Secondary ID: 1OT2OD023854
• Status: Completed
• Start date: January 10, 2020
• Est. completion date: August 20, 2022

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 20, 2022
• Est. primary completion date: August 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	UF Health - Jacksonville	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Electromyogram (EMG)	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.	Baseline up to 24 hours
Primary	Change in Maximal Inspiratory Pressure (MIP)	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).	Baseline up to 24 hours
Primary	Change in Tidal Volume	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).	Baseline up to 24 hours