Diaphragm Pacing in Individuals With Spinal Cord Injuries
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|ClinicalTrials.gov Identifier: NCT04179799|
Recruitment Status : Active, not recruiting
First Posted : November 27, 2019
Last Update Posted : October 27, 2022
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|Condition or disease||Intervention/treatment|
|Cervical Spinal Cord Injury||Device: Diaphragm Pacing|
|Study Type :||Observational|
|Actual Enrollment :||6 participants|
|Official Title:||Diaphragm Stimulation After Human Spinal Cord Injury: Effects on Respiratory Neural Drive and Function|
|Actual Study Start Date :||January 10, 2020|
|Actual Primary Completion Date :||October 21, 2022|
|Estimated Study Completion Date :||October 18, 2025|
Participants with acute, traumatic cervical spinal cord injuries (C-SCIs), classified according to the American Spinal Injury Association (ASIA) Impairment Scale (AIS) as A-C (complete SCI (A); motor complete SCI (B); motor incomplete with minimal motor function (C)), affecting C1-C6 spinal cord segments, and who have been 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.
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.
- 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.
- 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).
- 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).
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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
- 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
- Cognitive impairments limiting study participation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04179799
|United States, Florida|
|UF Health - Jacksonville|
|Jacksonville, Florida, United States, 32008|
|Principal Investigator:||Emily Fox, PT, PhD||University of Florida|
|Responsible Party:||University of Florida|
|Other Study ID Numbers:||
1OT2OD023854 ( U.S. NIH Grant/Contract )
|First Posted:||November 27, 2019 Key Record Dates|
|Last Update Posted:||October 27, 2022|
|Last Verified:||October 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System