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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT01117090
First received: May 3, 2010
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Cerebral Palsy
Chronic Pain
Traumatic Brain Injury
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility of Measuring Cerebrospinal Fluid (CSF) Signatures in Subjects With Intrathecal Catheter-Related Problems

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • CSF signatures compared with the physician-confirmed diagnosis. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Collect and characterize, by comparison with the physician-confirmed 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:
  • The relationship between CSF signatures and physician's confirmed medical diagnosis. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Characterize the relationship between CSF signature data and the physician's confirmed medical diagnosis as determined by catheter-troubleshooting procedures.

  • CSF signatures during physical task protocol [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Characterize CSF signatures during physical task protocol.

  • Adverse events during study [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Summarize all adverse events reported after enrollment through 60 days following surgery in subjects diagnosed with catheter-related problems, and 60 days following completion of troubleshooting procedure in subjects who do not undergo surgery because their catheters appear to be functioning normally.


Enrollment: 47
Study Start Date: June 2010
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Detailed Description:

The purpose of this feasibility study is to record cerebrospinal fluid 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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117090

Locations
United States, Indiana
Goodman Campbell Brain and Spine
Indianapolis, Indiana, United States, 46202
United States, Pennsylvania
Moss Rehab
Philadelphia, Pennsylvania, United States, 19027
Sponsors and Collaborators
MedtronicNeuro
Investigators
Principal Investigator: Michael S Turner, MD Goodman Campbell Brain and Spine
Principal Investigator: Michael Saulino, MD Moss Rehab
  More Information

No publications provided

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01117090     History of Changes
Other Study ID Numbers: 1656
Study First Received: May 3, 2010
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cerebral Palsy
Spinal Cord Injuries
Brain Injuries
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Craniocerebral Trauma

ClinicalTrials.gov processed this record on May 19, 2013