Follow up Study of Diaphragm Pacing for Patients With High Tetraplegia

Completed

Conditions studied: Tetraplegia, Spinal Cord Injury

In brief

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)?

Key facts

Study ID

NCT01815554

Run by

Craig Hospital

People needed

31

Starts

2013-01-01

Expected to finish

2016-04-01

Last updated by the study team

2017-01-31

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Implementation of DPS prior to 2003

Where it is running

• Craig Hospital — Englewood, Colorado, United States

Full record on ClinicalTrials.gov

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