Cerebral Palsy, Multiple Sclerosis, Spinal Cord Injury, Traumatic Brain Injury
Conditions
Keywords
Feasibility, SynchroMed II, Intrathecal catheter, Baclofen
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.
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.
Interventions
None listed
Sponsors
MedtronicNeuro
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Relationship Between Catheter Flow Resistance Check Data and Physician's Standard Trouble-shooting Diagnosis | 1 day | Characterize the relationship between pressure decay-to-baseline time (in seconds) and the physician's standard trouble-shooting diagnosis |
| The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Cough | 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 |
| The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Valsalva | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | Intrathecal Pump Patients |
|---|---|
| Age, Categorical <=18 years | 7 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants |
| Age, Continuous | 37.8 years STANDARD_DEVIATION 16.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Infusion system spasticity treatment sub-indication Brain injury | 3 participants |
| Infusion system spasticity treatment sub-indication Cerebral palsy | 25 participants |
| Infusion system spasticity treatment sub-indication Multiple sclerosis | 8 participants |
| Infusion system spasticity treatment sub-indication Other | 6 participants |
| Infusion system spasticity treatment sub-indication Spinal cord injury | 2 participants |
| Infusion system spasticity treatment sub-indication Stroke | 3 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 44 Participants |
| Region of Enrollment United States | 47 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 47 |
| serious Total, serious adverse events | 14 / 47 |
Outcome results
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.
Time frame: 1 day
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects With Normal Catheter Function by Physician Diagnosis | Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis | 13 Subjects whose CSF data agree with MD Dx |
| Subjects With Catheter Complications by Physician Diagnosis | Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis | 16 Subjects whose CSF data agree with MD Dx |
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
Time frame: 1 day
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects With Normal Catheter Function by Physician Diagnosis | The Relationship Between Catheter Flow Resistance Check Data and Physician's Standard Trouble-shooting Diagnosis | 6.4 seconds | Standard Deviation 15.3 |
| Subjects With Catheter Complications by Physician Diagnosis | The Relationship Between Catheter Flow Resistance Check Data and Physician's Standard Trouble-shooting Diagnosis | 19.9 seconds | Standard Deviation 18.1 |
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
Time frame: 1 day
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects With Normal Catheter Function by Physician Diagnosis | The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Cough | 21.0 mmHg | Standard Deviation 13.8 |
| Subjects With Catheter Complications by Physician Diagnosis | The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Cough | 6.6 mmHg | Standard Deviation 6.7 |
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
Time frame: 1 day
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects With Normal Catheter Function by Physician Diagnosis | The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Valsalva | 18.7 mmHg | Standard Deviation 12.8 |
| Subjects With Catheter Complications by Physician Diagnosis | The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Valsalva | 4.8 mmHg | Standard Deviation 5.8 |