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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 day |
| The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Cough |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Michael S Turner, MD | Goodman Campbell Brain and Spine | Principal Investigator |
| Michael Saulino, MD | Moss Rehab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goodman Campbell Brain and Spine | Indianapolis | Indiana | 46202 | United States | ||
| Moss Rehab |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20733347 | Background | 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. | |
| Result | 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). | ||
| 27477589 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intrathecal Pump Patients | Subjects previously implanted with an intrathecal pump who satisfied all inclusion and exclusion criteria, provided written informed consent, and had a needle inserted into the catheter access port of the implanted pump were considered to be enrolled in the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intrathecal Pump Patients | Subjects who satisfied all inclusion and exclusion criteria, provided written informed consent, and had a needle inserted into the catheter access port of the implanted pump were considered to be enrolled in the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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 | Posted | Number | Subjects whose CSF data agree with MD Dx | 1 day |
|
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.
All adverse events were collected for the duration of the study. No adverse events were associated with the measurement of CSF pressure energy, including insertion of the needle into the CAP and subsequent data acquisition lasting 6.3 ± 2.9 minutes (mean ± SD).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intrathecal Pump Patients | Subjects who satisfied all inclusion and exclusion criteria, provided written informed consent, and had a needle inserted into the catheter access port of the implanted pump were considered to be enrolled in the study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incision site complication | General disorders | MedDRA (8.0) | Systematic Assessment |
"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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Restorative Therapies Group Clinical Trials | Medtronic Restorative Therapies Group - Targeted Drug Delivery | medtronicneurotrials@medtronic.com |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D009103 | Multiple Sclerosis |
| D000070642 | Brain Injuries, Traumatic |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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 | 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 |
| Philadelphia |
| Pennsylvania |
| 19027 |
| United States |
| 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Infusion system spasticity treatment sub-indication | The primary treatment indication for all subjects was severe spasticity. This measure describes the treatment sub-indication for each subject. | Number | participants |
|
| OG001 |
| Subjects With Catheter Complications by Physician Diagnosis |
Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of catheter complication from the physician |
|
|
| Secondary | 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 | Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, if there was an issue with the equipment, if the clamp was not open, or if the resistance check data were missing. | Posted | Mean | Standard Deviation | seconds | 1 day |
|
|
|
| Secondary | 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 | Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, if there was an issue with the equipment, or if the subject was unable to cough. | Posted | Mean | Standard Deviation | mmHg | 1 day |
|
|
|
| Secondary | 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 | Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, if there was an issue with the equipment, if the subject was unable to perform the valsalva, or if data were missing. | Posted | Mean | Standard Deviation | mmHg | 1 day |
|
|
|
| 14 |
| 47 |
| 6 |
| 47 |
| Infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Muscle spasticity | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Drug withdrawal syndrom | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Implant site effusion | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Lumbar puncture headache | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Underdose | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Muscle spasticity | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| Wound dehiscence | General disorders | MedDRA (8.0) | Systematic Assessment |
|
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| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D013118 | Spinal Cord Diseases |