N/A
N=47
Measuring Signatures in the Fluid Surrounding the Spinal Cord in Patients Who Have Problems With Intrathecal Drug Delivery
Cerebral Palsy · Multiple Sclerosis · Traumatic Brain Injury · Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT01117090 ↗Enrolled (actual)
47
Serious AEs
29.8%
Results posted
Nov 2013
Primary outcome: Primary: Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis — 13; 16 Subjects whose CSF data agree with MD Dx
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- MedtronicNeuro
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis |
13; 16 | — |
| SECONDARY The Relationship Between Catheter Flow Resistance Check Data and Physician's Standard Trouble-shooting Diagnosis |
6.4; 19.9 | — |
| SECONDARY The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Cough |
21.0; 6.6 | — |
| SECONDARY The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Valsalva |
18.7; 4.8 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01117090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.