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Completed

NCT Number: NCT01117090

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

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.

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Goodman Campbell Brain and Spine, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 5, 2010
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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