Clinical Trial: Follow up Study of Diaphragm Pacing for Patients With High Tetraplegia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational



Official Title: Long-term Follow-up of Patients With Ventilatory Dependent High Tetraplegia Managed With Diaphragmatic Pacing Systems

Brief 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)?