Measuring Signatures in the Fluid Surrounding the Spinal Cord in Patients Who Have Problems With Intrathecal Drug Delivery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cerebral Palsy Multiple Sclerosis Traumatic Brain Injury Spinal Cord Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No