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: September 12, 2013
Last verified: September 2013
  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
Multiple Sclerosis
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:


Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The Relationship Between Catheter Flow Resistance Check Data and Physician's Standard Trouble-shooting Diagnosis [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Characterize the relationship between pressure decay-to-baseline time (in seconds) and the physician's standard trouble-shooting diagnosis

  • The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Cough [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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

  • The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Valsalva [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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


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 (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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01117090     History of Changes
Other Study ID Numbers: 1656
Study First Received: May 3, 2010
Results First Received: September 12, 2013
Last Updated: September 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by MedtronicNeuro:
Feasibility
SynchroMed II
Intrathecal catheter
Baclofen

Additional relevant MeSH terms:
Cerebral Palsy
Multiple Sclerosis
Sclerosis
Spinal Cord Injuries
Brain Injuries
Wounds and Injuries
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Spinal Cord Diseases
Trauma, Nervous System
Craniocerebral Trauma

ClinicalTrials.gov processed this record on August 28, 2014