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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117090
• Other study ID #: 1656
• Status: Completed
• Phase: N/A
• First received: May 3, 2010
• Last updated: September 12, 2013
• Start date: June 2010
• Est. completion date: December 2012

Study information

• Verified date: September 2013
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Palsy
• Multiple Sclerosis
• Spinal Cord Injuries
• Spinal Cord Injury
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Goodman Campbell Brain and Spine	Indianapolis	Indiana
United States	Moss Rehab	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No