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

MedtronicNeuro47 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Cerebral Palsy Multiple Sclerosis Traumatic Brain Injury Spinal Cord Injury

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (2)

Goodman Campbell Brain and Spine

Indianapolis, Indiana, United States

Moss Rehab

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 day

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 1 day

Data from ClinicalTrials.gov

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