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Follow up Study of Diaphragm Pacing for Patients With High Tetraplegia

NCT01815554 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2017-01-31

No results posted yet for this study

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)?

Conditions

  • Tetraplegia
  • Spinal Cord Injury

Sponsors & Collaborators

  • U.S. Department of Education

    collaborator FED

  • Craig Hospital

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01815554 on ClinicalTrials.gov