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

20. april 2017 opdateret af: MedtronicNeuro

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46202
    - Goodman Campbell Brain and Spine
- Pennsylvania
  - Philadelphia, Pennsylvania, Forenede Stater, 19027
    - Moss Rehab

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis Tidsramme: 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.	1 day

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
The Relationship Between Catheter Flow Resistance Check Data and Physician's Standard Trouble-shooting Diagnosis Tidsramme: 1 day	Characterize the relationship between pressure decay-to-baseline time (in seconds) and the 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 Tidsramme: 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	1 day
The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Valsalva Tidsramme: 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	1 day

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

MedtronicNeuro

Efterforskere

Ledende efterforsker: Michael S Turner, MD, Goodman Campbell Brain and Spine
Ledende efterforsker: Michael Saulino, MD, Moss Rehab

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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.
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).
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.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2010

Primær færdiggørelse (Faktiske)

1. september 2012

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

3. maj 2010

Først indsendt, der opfyldte QC-kriterier