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

Completed

• Conditions: Traumatic Brain Injury; Multiple Sclerosis; Spinal Cord Injury; Cerebral Palsy

• Registration Number: NCT01117090
• Lead Sponsor: MedtronicNeuro

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.

Study Timeline

• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-05
• Study Start: 2010-06
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Results First Submitted: 2013-09-12
• Results First Submitted QC: 2013-09-12
• Results First Posted: 2013-11-18
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-20
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis	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 Outcome Measures

Name	Time	Method
The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Cough	1 day	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
The Relationship Between Catheter Flow Resistance Check Data and Physician's Standard Trouble-shooting Diagnosis	1 day	Characterize the relationship between pressure decay-to-baseline time (in seconds) and the physician's standard trouble-shooting diagnosis
The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Valsalva	1 day	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

Trial Locations

Locations (2)

Moss Rehab; 🇺🇸 Philadelphia, Pennsylvania, United States

Goodman Campbell Brain and Spine; 🇺🇸 Indianapolis, Indiana, United States