CompletedNot Applicable

Follow up Study of Diaphragm Pacing for Patients With High Tetraplegia

United States31 participantsStarted 2013-01

Plain-language 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)?

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Long-term utilization, effectiveness, satisfaction, durability and safety of implanted Diaphragmatic Pacing Systems

Timeframe: 1 year anniversary of original implemenation date

Long-term utilization, effectiveness, satisfaction, durability and safety of implanted Diaphragmatic Pacing Systems

Timeframe: 3 year anniversary of original implemenation date

Long-term utilization, effectiveness, satisfaction, durability and safety of implanted Diaphragmatic Pacing Systems

Timeframe: 5 year anniversary of original implemenation date

Long-term utilization, effectiveness, satisfaction, durability and safety of implanted Diaphragmatic Pacing Systems

Timeframe: 7 year anniversary of original implemenation date

Trial details

NCT IDNCT01815554

SponsorCraig Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-04

View on ClinicalTrials.gov More Tetraplegia trials