Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01815554
Other study ID # 133N110006
Secondary ID
Status Completed
Phase N/A
First received March 18, 2013
Last updated January 30, 2017
Start date January 2013
Est. completion date April 2016

Study information

Verified date January 2017
Source Craig Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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)?


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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Locations

Country Name City State
United States Craig Hospital Englewood Colorado

Sponsors (2)

Lead Sponsor Collaborator
Craig Hospital U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year anniversary of original implemenation date
Primary 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. 3 year anniversary of original implemenation date
Primary 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. 5 year anniversary of original implemenation date
Primary 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. 7 year anniversary of original implemenation date
See also
  Status Clinical Trial Phase
Recruiting NCT02574572 - Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury Phase 1
Recruiting NCT05941819 - ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury N/A
Completed NCT05265377 - Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury N/A
Recruiting NCT02331979 - Improving Bladder Function in SCI by Neuromodulation N/A
Completed NCT02777281 - Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI N/A
Recruiting NCT02978638 - Electrical Stimulation for Continence After Spinal Cord Injury N/A
Completed NCT02161913 - Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers N/A
Withdrawn NCT02237547 - Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury Phase 1/Phase 2
Completed NCT02262234 - Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study Phase 1/Phase 2
Terminated NCT02080039 - Electrical Stimulation of Denervated Muscles After Spinal Cord Injury N/A
Completed NCT01642901 - Zoledronic Acid in Acute Spinal Cord Injury Phase 3
Completed NCT01884662 - Virtual Walking for Neuropathic Pain in Spinal Cord Injury N/A
Completed NCT01471613 - Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury Phase 1/Phase 2
Terminated NCT01433159 - Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury Phase 2
Completed NCT01467817 - Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI) N/A
Completed NCT02149511 - Longitudinal Morphometric Changes Following SCI
Completed NCT01025609 - Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
Terminated NCT01005615 - Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury Phase 1/Phase 2
Completed NCT00663663 - Telephone Intervention for Pain Study (TIPS) N/A
Completed NCT01086930 - Early Intensive Hand Rehabilitation After Spinal Cord Injury Phase 3