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

NCT01117090 | Completed Results

• 1 other identifier: 1656
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy; Multiple Sclerosis; Traumatic Brain Injury; Spinal Cord Injury

Keywords

Feasibility; SynchroMed II; Intrathecal catheter; Baclofen

Outcome Measures

Primary Outcomes (1)

• Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis

  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.

  1 day

Secondary Outcomes (3)

• The Relationship Between Catheter Flow Resistance Check Data and Physician's Standard Trouble-shooting Diagnosis

  1 day

• The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Cough

  1 day

• The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Valsalva

  1 day

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (2)

Goodman Campbell Brain and Spine

Indianapolis, Indiana, 46202, United States

Location

Moss Rehab

Philadelphia, Pennsylvania, 19027, United States

Location

Related Publications (3)

• 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.

  PMID: 20733347 BACKGROUND

• 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).

  RESULT

• 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.

  PMID: 27477589 RESULT

MeSH Terms

Conditions

Cerebral Palsy; Multiple Sclerosis; Brain Injuries, Traumatic; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases

Limitations and Caveats

"Normal" subjects who received intrathecal baclofen without experiencing catheter complications were not enrolled. Subjects who received intrathecal drug delivery for chronic pain were not enrolled. This was not a longitudinal study.

Results Point of Contact

• Title: Restorative Therapies Group Clinical Trials
• Organization: Medtronic Restorative Therapies Group - Targeted Drug Delivery

medtronicneurotrials@medtronic.com

Study Officials

• Michael S Turner, MD

  Goodman Campbell Brain and Spine

  PRINCIPAL INVESTIGATOR

• Michael Saulino, MD

  Moss Rehab

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 30, 2017
• Results First Posted: November 18, 2013

Record last verified: 2017-04

Locations

US (2)