Follow up Study of Diaphragm Pacing for Patients With High Tetraplegia

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Craig Hospital
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Craig Hospital
ClinicalTrials.gov Identifier:
NCT01815554
First received: March 18, 2013
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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)?

Condition
Tetraplegia
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long-term Follow-up of Patients With Ventilatory Dependent High Tetraplegia Managed With Diaphragmatic Pacing Systems

Resource links provided by NLM:


Further study details as provided by Craig Hospital:

Primary Outcome Measures:
  • Long-term utilization, effectiveness, satisfaction, durability and safety of implanted Diaphragmatic Pacing Systems [ Time Frame: 1 year anniversary of original implemenation date ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01815554

Contacts
Contact: Dan Lammertse, MD DLammertse@CraigHospital.org

Locations
United States, Colorado
Craig Hospital Recruiting
Englewood, Colorado, United States, 80113
Contact: Dan Lammertse, MD       DLammertse@CraigHospital.org   
Principal Investigator: Dan Lammertse, MD         
Sponsors and Collaborators
Craig Hospital
U.S. Department of Education
  More Information

No publications provided

Responsible Party: Craig Hospital
ClinicalTrials.gov Identifier: NCT01815554     History of Changes
Other Study ID Numbers: 133N110006
Study First Received: March 18, 2013
Last Updated: August 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Craig Hospital:
Tetraplegia
Spinal Cord Injury
Ventilator
Diaphragmatic Pacing System

Additional relevant MeSH terms:
Quadriplegia
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014