TetraplegiaNCT01815554
Follow up Study of Diaphragm Pacing for Patients With High Tetraplegia
An observational study of Tetraplegia and Spinal Cord Injury, run by Craig Hospital at 1 site in United States.
Trial summary
This is an observational longitudinal study designed to identify and describe long term outcomes for patients with high tetraplegia who use a Diaphragmatic Pacing System (DPS). As this is not a randomized or experimental study, no specific hypotheses are proposed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tetraplegia, Spinal Cord Injury
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All individuals implanted with DPS since 2003 who are being followed at one of the 6 collaborating study sites, including individuals who undergo DPS implantation during the funding cycle through October of 2014. Currently, there are approximately 60 individuals who comprise the existing clinical cohort of eligible participants. Individuals who are implanted during the funding cycle also will be eligible for study inclusion.
Who may be able to join
- Patients previously incurring a traumatic spinal cord injury resulting in high tetraplegia
- Patients implanted with DPS
Who cannot join
- Implementation of DPS prior to 2003
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Follow-up of Patients With Ventilatory Dependent High Tetraplegia Managed With Diaphragmatic Pacing Systems
This is an observational longitudinal study designed to identify and describe long term outcomes for patients with high tetraplegia who use a Diaphragmatic Pacing System (DPS). As this is not a randomized or experimental study, no specific hypotheses are proposed. The data collected will enable us to answer the following research questions:
- What are the patterns of long-term DPS use (hours per day using DPS, changes in DPS stimulus parameters, abandonment of DPS and related reasons).
- What mechanical problems have DPS users encountered (system failure, repairs needed)?
- What are the frequency of and reasons for rehospitalization following DPS implant?
- What levels of care are needed at home to manage the DPS?
- How do DPS users feel about the system (satisfaction, comfort, vocalization, taste, swallowing)?
Read the detailed description
Ventilatory dependent high tetraplegia is a relatively rare but devastating condition. Review of National Spinal Cord Injury Database statistics show that only 3.6% of patients with tetraplegia are ventilator dependent at one year post injury.1 A subset of individuals who are ventilatory dependent in the long term and have upper motor neuron paralysis of the diaphragm are candidates for electrophrenic respiration (EPR) which can create inspiratory function through electrical stimulation of the phrenic nerves, resulting in diaphragmatic contraction. The use of this technology in ventilatory dependent tetraplegia was first described almost 40 years ago with a pacing system using cuff electrodes surgically placed around the phrenic nerve in the neck.2 The concept of EPR via minimally invasive laparoscopically placed diaphragmatic electrodes was first reported in 2002.3 This new Diaphragmatic Pacing System (DPS) had the distinct advantage of requiring less invasive surgery for electrode implantation compared to the phrenic cuff electrode system which required surgical exploration of the neck. In some settings, the DPS system has been implanted as an outpatient surgery. The DPS had a potential disadvantage however in that, unlike the traditional EPR system, the stimulating electrode leads are externalized posing an infection risk and the electrodes are attached to a moving muscle creating a risk for dislodgement. Once the system achieved FDA Humanitarian Use Device (HUD) exemption status in 2008, there was adoption of the Diaphragm Pacing System (DPS) among a number of SCI centers as a treatment option for patients with ventilatory dependent high tetraplegia. Reporting of long-term outcomes of DPS in the SCI population is limited to a 2009 report authored by the system inventor on 50 patients with average follow-up of 2.0 ± 1.5 years (median 1.6 years, range 0.5-8.0 years).4 The six SCIMS centers participating in this module research propose to collect long-term follow-up data on DPS patients implanted and/or followed at their centers since 2007. This project will enable the reporting of independent long-term utilization, effectiveness, satisfaction, durability and safety outcomes of this innovative technology.
- Conditions
- Tetraplegia, Spinal Cord Injury
- Keywords
- Tetraplegia, Spinal Cord Injury, Ventilator, Diaphragmatic Pacing System
- Medical subject headings
- Quadriplegia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DPS Cohort | All patients implanted with a DPS within the past 5 years at one of 6 collaborating sites will be included. Patients will be interviewed as they cross their 1st, 3rd, 5th or 7th anniversary with the DPS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term utilization, effectiveness, satisfaction, durability and safety of implanted Diaphragmatic Pacing Systems
Patients implanted with a DPS within the past 5 years will be included in this study. Telephone or in-person interviews will be conducted with the above individuals as they cross their 1st, 3rd, 5th, or 7th anniversary with the DPS system. All individuals are expected to complete at least 2 interviews during the study period.
Measured: 1 year anniversary of original implemenation date
Long-term utilization, effectiveness, satisfaction, durability and safety of implanted Diaphragmatic Pacing Systems
Patients implanted with a DPS within the past 5 years will be included in this study. Telephone or in-person interviews will be conducted with the above individuals as they cross their 1st, 3rd, 5th, or 7th anniversary with the DPS system. All individuals are expected to complete at least 2 interviews during the study period.
Measured: 3 year anniversary of original implemenation date
Long-term utilization, effectiveness, satisfaction, durability and safety of implanted Diaphragmatic Pacing Systems
Patients implanted with a DPS within the past 5 years will be included in this study. Telephone or in-person interviews will be conducted with the above individuals as they cross their 1st, 3rd, 5th, or 7th anniversary with the DPS system. All individuals are expected to complete at least 2 interviews during the study period.
Measured: 5 year anniversary of original implemenation date
Long-term utilization, effectiveness, satisfaction, durability and safety of implanted Diaphragmatic Pacing Systems
Patients implanted with a DPS within the past 5 years will be included in this study. Telephone or in-person interviews will be conducted with the above individuals as they cross their 1st, 3rd, 5th, or 7th anniversary with the DPS system. All individuals are expected to complete at least 2 interviews during the study period.
Measured: 7 year anniversary of original implemenation date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetraplegiaStudies of the same condition, open and under way.
- 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815554
- Sponsor's protocol ID
- 133N110006
- Status last verified
- Jan 2017
- First submitted
- 18 Mar 2013
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Patients With Ventilatory Dependent High Tetraplegia Managed With Diaphragmatic Pacing Systems
- ClinicalTrials.gov ID
- NCT01815554
- Acronym / sponsor ID
- 133N110006
- Conditions
- Tetraplegia, Spinal Cord Injury
- Keywords
- Tetraplegia, Spinal Cord Injury, Ventilator, Diaphragmatic Pacing System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Jan 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 21 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational longitudinal study designed to identify and describe long term outcomes for patients with high tetraplegia who use a Diaphragmatic Pacing System (DPS). As this is not a randomized or experimental study, no specific hypotheses are proposed. The data collected will enable us to answer the following research questions:
- What are the patterns of long-term DPS use (hours per day using DPS, changes in DPS stimulus parameters, abandonment of DPS and related reasons).
- What mechanical problems have DPS users encountered (system failure, repairs needed)?
- What are the frequency of and reasons for rehospitalization following DPS implant?
- What levels of care are needed at home to manage the DPS?
- How do DPS users feel about the system (satisfaction, comfort, vocalization, taste, swallowing)?
Detailed description
Ventilatory dependent high tetraplegia is a relatively rare but devastating condition. Review of National Spinal Cord Injury Database statistics show that only 3.6% of patients with tetraplegia are ventilator dependent at one year post injury.1 A subset of individuals who are ventilatory dependent in the long term and have upper motor neuron paralysis of the diaphragm are candidates for electrophrenic respiration (EPR) which can create inspiratory function through electrical stimulation of the phrenic nerves, resulting in diaphragmatic contraction. The use of this technology in ventilatory dependent tetraplegia was first described almost 40 years ago with a pacing system using cuff electrodes surgically placed around the phrenic nerve in the neck.2 The concept of EPR via minimally invasive laparoscopically placed diaphragmatic electrodes was first reported in 2002.3 This new Diaphragmatic Pacing System (DPS) had the distinct advantage of requiring less invasive surgery for electrode implantation compared to the phrenic cuff electrode system which required surgical exploration of the neck. In some settings, the DPS system has been implanted as an outpatient surgery. The DPS had a potential disadvantage however in that, unlike the traditional EPR system, the stimulating electrode leads are externalized posing an infection risk and the electrodes are attached to a moving muscle creating a risk for dislodgement. Once the system achieved FDA Humanitarian Use Device (HUD) exemption status in 2008, there was adoption of the Diaphragm Pacing System (DPS) among a number of SCI centers as a treatment option for patients with ventilatory dependent high tetraplegia. Reporting of long-term outcomes of DPS in the SCI population is limited to a 2009 report authored by the system inventor on 50 patients with average follow-up of 2.0 ± 1.5 years (median 1.6 years, range 0.5-8.0 years).4 The six SCIMS centers participating in this module research propose to collect long-term follow-up data on DPS patients implanted and/or followed at their centers since 2007. This project will enable the reporting of independent long-term utilization, effectiveness, satisfaction, durability and safety outcomes of this innovative technology.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DPS Cohort | – | –All patients implanted with a DPS within the past 5 years at one of 6 collaborating sites will be included. Patients will be interviewed as they cross their 1st, 3rd, 5th or 7th anniversary with the DPS. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals implanted with DPS since 2003 who are being followed at one of the 6 collaborating study sites, including individuals who undergo DPS implantation during the funding cycle through October of 2014. Currently, there are approximately 60 individuals who comprise the existing clinical cohort of eligible participants. Individuals who are implanted during the funding cycle also will be eligible for study inclusion.
Key inclusion criteria (2 listed)
- Patients previously incurring a traumatic spinal cord injury resulting in high tetraplegia
- Patients implanted with DPS
Key exclusion criteria (1 listed)
- Implementation of DPS prior to 2003
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long-term utilization, effectiveness, satisfaction, durability and safety of implanted Diaphragmatic Pacing Systems
Time frame: 1 year anniversary of original implemenation date
Patients implanted with a DPS within the past 5 years will be included in this study. Telephone or in-person interviews will be conducted with the above individuals as they cross their 1st, 3rd, 5th, or 7th anniversary with the DPS system. All individuals are expected to complete at least 2 interviews during the study period.
Long-term utilization, effectiveness, satisfaction, durability and safety of implanted Diaphragmatic Pacing Systems
Time frame: 3 year anniversary of original implemenation date
Patients implanted with a DPS within the past 5 years will be included in this study. Telephone or in-person interviews will be conducted with the above individuals as they cross their 1st, 3rd, 5th, or 7th anniversary with the DPS system. All individuals are expected to complete at least 2 interviews during the study period.
Long-term utilization, effectiveness, satisfaction, durability and safety of implanted Diaphragmatic Pacing Systems
Time frame: 5 year anniversary of original implemenation date
Patients implanted with a DPS within the past 5 years will be included in this study. Telephone or in-person interviews will be conducted with the above individuals as they cross their 1st, 3rd, 5th, or 7th anniversary with the DPS system. All individuals are expected to complete at least 2 interviews during the study period.
Long-term utilization, effectiveness, satisfaction, durability and safety of implanted Diaphragmatic Pacing Systems
Time frame: 7 year anniversary of original implemenation date
Patients implanted with a DPS within the past 5 years will be included in this study. Telephone or in-person interviews will be conducted with the above individuals as they cross their 1st, 3rd, 5th, or 7th anniversary with the DPS system. All individuals are expected to complete at least 2 interviews during the study period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tetraplegia and Spinal Cord Injury, run by Craig Hospital 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 1 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 31 Jan 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Long-term utilization, effectiveness, satisfaction, durability and safety of implanted Diaphragmatic Pacing Systems (time frame: 1 year anniversary of original implemenation date). The study lists 4 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 31 Jan 2017.