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

An observational study of Cerebral Palsy and Multiple Sclerosis, run by MedtronicNeuro at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Cerebral Palsy, Multiple Sclerosis, Traumatic Brain Injury
How many people: 47 participants
Where: 2 sitesUnited States
Study dates: Jun 2010to Dec 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Cerebral Palsy, Multiple Sclerosis, Traumatic Brain Injury, Spinal Cord Injury
Keywords: Feasibility, SynchroMed II, Intrathecal catheter, Baclofen
Medical subject headings: Cerebral Palsy, Multiple Sclerosis, Brain Injuries, Traumatic, Spinal Cord Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 day

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Dec 2012

First posted5 May 2010 (estimated)
Study startJun 2010
Primary completionSep 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Cerebral PalsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01117090
Sponsor's protocol ID: 1656
Status last verified: Apr 2017
First submitted: 3 May 2010
Last updated: 30 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 20733347
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.
PubMed 27477589

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cerebral Palsy trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility of Measuring Cerebrospinal Fluid (CSF) Signatures in Subjects With Intrathecal Catheter-Related Problems
ClinicalTrials.gov ID: NCT01117090
Acronym / sponsor ID: 1656
Conditions: Cerebral Palsy, Multiple Sclerosis, Traumatic Brain Injury, Spinal Cord Injury
Keywords: Feasibility, SynchroMed II, Intrathecal catheter, Baclofen
Study type: Observational
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: MedtronicNeuroIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Sep 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 5 May 2010 (estimated)
Results: Posted 18 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

3 secondary outcomes

The Relationship Between Catheter Flow Resistance Check Data and Physician's Standard Trouble-shooting Diagnosis
Time frame: 1 day
The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Cough
Time frame: 1 day
The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Valsalva
Time frame: 1 day

Results and safety

Results posted to the registry on 18 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intrathecal Pump Patients	47	47

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

Time frame: 1 day. Number. Unit: Subjects whose CSF data agree with MD Dx

Measure	Subjects With Normal Catheter Function by Physician Diagnosis n = 19	Subjects With Catheter Complications by Physician Diagnosis n = 18
Value	13	16

Population analysed: Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, or if there was an issue with the equipment

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded throughout this research study, from time of subject enrollment to subject discontinuation. The minimum duration of subject follow-up was 47 days; the maximum was 287 days.. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intrathecal Pump Patients	14 of 47 (29.8%)	6 of 47 (12.8%)	Not reported

Limitations and caveats (from the sponsor): "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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20733347Coffey 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.
Results publicationSaulino 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).
Results publication: PubMed 27477589Saulino 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.

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Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael S Turner, MD principal investigator

Goodman Campbell Brain and Spine

Michael Saulino, MD principal investigator

Moss Rehab

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy and Multiple Sclerosis, run by MedtronicNeuro at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01117090, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.