Multiple Sclerosis Clinical Trial
Measuring Signatures in the Fluid Surrounding the Spinal Cord in Patients Who Have Problems With Intrathecal Drug Delivery
Summary
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.
Full Description
The purpose of this feasibility study is to record cerebrospinal fluid (CSF) 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.
Eligibility Criteria
Inclusion Criteria:
Be at least 12 years of age
Have an implanted Medtronic drug infusion system for chronic intrathecal administration of drugs
Report decreased therapeutic benefit, or show visible signs and/or symptoms of decreased therapeutic benefit
Agree to undergo clinical tests designed to troubleshoot catheter-related problems or failure as a part of their normal standard of care
Agree to provide signed informed consent.
Exclusion Criteria:
Are currently enrolled or plan to enroll in another investigational drug or device trial
Have participated in an investigational drug or device study within 30 days of the in-clinic visit
Whose health status would, in the opinion of the Clinical Investigator, be jeopardized by participation in the study
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There are 2 Locations for this study
Indianapolis Indiana, 46202, United States
Philadelphia Pennsylvania, 19027, United States
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