Follow up Study of Diaphragm Pacing for Patients With High Tetraplegia

January 30, 2017 updated by: Craig Hospital

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:

  1. 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).
  2. What mechanical problems have DPS users encountered (system failure, repairs needed)?
  3. What are the frequency of and reasons for rehospitalization following DPS implant?
  4. What levels of care are needed at home to manage the DPS?
  5. How do DPS users feel about the system (satisfaction, comfort, vocalization, taste, swallowing)?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Craig Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Patients previously incurring a traumatic spinal cord injury resulting in high tetraplegia
  • Patients implanted with DPS

Exclusion Criteria:

  • Implementation of DPS prior to 2003

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year anniversary of original implemenation date
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.
3 year anniversary of original implemenation date
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.
5 year anniversary of original implemenation date
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.
7 year anniversary of original implemenation date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Craig Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
U.S. Department of Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 133N110006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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