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

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Feasibility of Measuring Cerebrospinal Fluid (CSF) Signatures in Subjects With Intrathecal Catheter-Related Problems

Conditions
-----------------
Cerebral Palsy, Multiple Sclerosis, Traumatic Brain Injury, Spinal Cord Injury

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis | Collect and characterize, by comparison with the physician's standard trouble-shooting 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Relationship Between Catheter Flow Resistance Check Data and Physician's Standard Trouble-shooting Diagnosis | Characterize the relationship between pressure decay-to-baseline time (in seconds) and the physician's standard trouble-shooting diagnosis | 1 day | 
| The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Cough | Collect and characterize, by comparison with the physician's standard trouble-shooting diagnosis, the mean change in CSF pressure data during the physical task of a cough | 1 day | 
| The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Valsalva | Collect and characterize, by comparison with the physician's standard trouble-shooting diagnosis, the mean change in CSF pressure data during the physical task of a valsalva maneuver | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Feasibility, SynchroMed II, Intrathecal catheter, Baclofen