Clinical trial NCT01117090: Measuring Signatures in the Fluid Surrounding the Spinal Cord in Patients Who Have Problems With Intrathecal Drug Delivery
Official title: Feasibility of Measuring Cerebrospinal Fluid (CSF) Signatures in Subjects With Intrathecal Catheter-Related Problems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Multiple Sclerosis
Traumatic Brain Injury
Spinal Cord Injury
Keywords: Feasibility
SynchroMed II
Intrathecal catheter
Baclofen
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2010-05-05
Enrollment: 47
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis
timeFrame: 1 day
Secondary outcomes:
measure: The Relationship Between Catheter Flow Resistance Check Data and Physician's Standard Trouble-shooting Diagnosis
timeFrame: 1 day
measure: The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Cough
timeFrame: 1 day
measure: The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Valsalva
timeFrame: 1 day
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Goodman Campbell Brain and Spine
state: Indiana
city: Philadelphia
country: United States
facility: Moss Rehab
state: Pennsylvania
Study officials:
affiliation: Goodman Campbell Brain and Spine
name: Michael S Turner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moss Rehab
name: Michael Saulino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 the 11th World Congress of the International Neuromodulation Society (June 2013; Berlin).
citation: 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.