Clinical Trial on Multiple Sclerosis, Cerebral Palsy, Traumatic Brain Injury, Spinal Cord Injury - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Goodman Campbell Brain and Spine
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19027
    - Moss Rehab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with implanted Medtronic drug infusion system for chronic intrathecal administration, and who report decreased therepeutic benefit or who present with visible signs and/or symptoms of decreased therapeutic benefit, suggesting possible catheter-related problems.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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 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.	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 Time Frame: 1 day	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 Time Frame: 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	1 day
The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Valsalva Time Frame: 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	1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedtronicNeuro

Investigators

Principal Investigator: Michael S Turner, MD, Goodman Campbell Brain and Spine
Principal Investigator: Michael Saulino, MD, Moss Rehab

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Coffey RJ, Miesel K, Billstrom T. Cerebrospinal fluid pressure measurement in the ovine intrathecal space: a preliminary study towards the diagnosis of intrathecal drug administration catheter dislodgement or occlusion. Stereotact Funct Neurosurg. 2010;88(6):337-44. doi: 10.1159/000319034. Epub 2010 Aug 21.
Saulino M, Miesel K, Turner M, Cochran F, Stromberg K, Fehrmann E, Markert M. Can CSF pressure signals distinguish catheter complications from normal catheter function in subjects who experience loss of intrathecal baclofen therapy? Abstract submitted to the 11th World Congress of the International Neuromodulation Society (June 2013; Berlin).
Saulino M, Turner M, Miesel K, Cochran FR, Stromberg K, Fehrmann E, Markert M, Spencer R. Can Cerebrospinal Fluid Pressure Detect Catheter Complications in Patients Who Experience Loss of Effectiveness With Intrathecal Baclofen Therapy? Neuromodulation. 2017 Feb;20(2):187-197. doi: 10.1111/ner.12471. Epub 2016 Aug 1.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria