Measuring Signatures in the Fluid Surrounding the Spinal Cord in Patients Who Have Problems With Intrathecal Drug Delivery
The purpose of this study is to record signatures from the fluid surrounding the spinal cord from people who have an implanted drug infusion system.
Traumatic Brain Injury
Spinal Cord Injury
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Feasibility of Measuring Cerebrospinal Fluid (CSF) Signatures in Subjects With Intrathecal Catheter-Related Problems|
- CSF signatures compared with the physician-confirmed diagnosis. [ Time Frame: 1 day ] [ Designated as safety issue: No ]Collect and characterize, by comparison with the physician-confirmed diagnosis, CSF signatures recorded in subjects who have an infusion system who present with signs and/or symptoms of possible catheter-related problems or failure.
- The relationship between CSF signatures and physician's confirmed medical diagnosis. [ Time Frame: 1 day ] [ Designated as safety issue: No ]Characterize the relationship between CSF signature data and the physician's confirmed medical diagnosis as determined by catheter-troubleshooting procedures.
- CSF signatures during physical task protocol [ Time Frame: 1 day ] [ Designated as safety issue: No ]Characterize CSF signatures during physical task protocol.
- Adverse events during study [ Time Frame: 60 days ] [ Designated as safety issue: No ]Summarize all adverse events reported after enrollment through 60 days following surgery in subjects diagnosed with catheter-related problems, and 60 days following completion of troubleshooting procedure in subjects who do not undergo surgery because their catheters appear to be functioning normally.
|Study Start Date:||June 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
The purpose of this feasibility study is to record cerebrospinal fluid signatures from subjects who have an implanted drug infusion system and who undergo clinical tests designed to troubleshoot possible catheter-related problems as part of their normal standard of care. Signatures will be correlated with physician-determined catheter status.
|United States, Indiana|
|Goodman Campbell Brain and Spine|
|Indianapolis, Indiana, United States, 46202|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19027|
|Principal Investigator:||Michael S Turner, MD||Goodman Campbell Brain and Spine|
|Principal Investigator:||Michael Saulino, MD||Moss Rehab|