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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:
ClinicalTrials.gov Identifier:
NCT01117090
First Posted: May 5, 2010
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MedtronicNeuro
  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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: May 3, 2010
First Posted: May 5, 2010
Results First Submitted: September 12, 2013
Results First Posted: November 18, 2013
Last Update Posted: May 30, 2017
Last Verified: April 2017

Keywords provided by MedtronicNeuro:
Feasibility
SynchroMed II
Intrathecal catheter
Baclofen

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