Feasibility of Measuring Cerebrospinal Fluid (CSF) Signatures in Subjects With Intrathecal Catheter-Related Problems
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Palsy
- Sponsor
- MedtronicNeuro
- Enrollment
- 47
- Locations
- 2
- Primary Endpoint
- Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis
- Status
- Completed
- Last Updated
- 8 years ago
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.
Investigators
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
Outcomes
Primary Outcomes
Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis
Time Frame: 1 day
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.
Secondary Outcomes
- The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Cough(1 day)
- The Relationship Between Catheter Flow Resistance Check Data and 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: Valsalva(1 day)