Cervical Spinal Cord InjuryNCT04179799
Diaphragm Pacing in Individuals With Spinal Cord Injuries
An observational study of Cervical Spinal Cord Injury, run by University of Florida at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cervical Spinal Cord Injury
- What is being tested?
- Diaphragm Pacing
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2020to 20 Aug 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute, traumatic C-SCIs, scheduled to receive intramuscular diaphragm pacing OR who have recently received a diaphragm pacer (within past 5-days) will be recruited from UF Health Shands Jacksonville, a Level-1 trauma hospital serving North Florida.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health - Jacksonville
Jacksonville, Florida, 32008
About this study
Official title: Diaphragm Stimulation After Human Spinal Cord Injury: Effects on Respiratory Neural Drive and Function
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.
Read the detailed 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.
- Conditions
- Cervical Spinal Cord Injury
- Being tested
- Diaphragm Pacing
- Keywords
- SCI, diaphragm pacing, respiratory impairment, diaphragm stimulation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm PacingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cervical SCI | 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. Receives: Device: Diaphragm Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 24 hours
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).
Measured: Baseline up to 24 hours
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).
Measured: Baseline up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start10 Jan 2020
- Primary completion20 Aug 2022
- Study completion20 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Emily Fox, PT, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179799
- Sponsor's protocol ID
- IRB201902285
- Other IDs
- 1OT2OD023854
- Status last verified
- May 2024
- First submitted
- 1 Nov 2019
- Last updated
- 30 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm Stimulation After Human Spinal Cord Injury: Effects on Respiratory Neural Drive and Function
- ClinicalTrials.gov ID
- NCT04179799
- Acronym / sponsor ID
- IRB201902285
- Conditions
- Cervical Spinal Cord Injury
- Keywords
- SCI, diaphragm pacing, respiratory impairment, diaphragm stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Posted 30 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical SCI | – | Device: Diaphragm PacingParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute, traumatic C-SCIs, scheduled to receive intramuscular diaphragm pacing OR who have recently received a diaphragm pacer (within past 5-days) will be recruited from UF Health Shands Jacksonville, a Level-1 trauma hospital serving North Florida.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragm PacingIntramuscular 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. | Device | Cervical SCI |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Fox, PT, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Spinal Cord Injury, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Electromyogram (EMG) (time frame: Baseline up to 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.