Trial Outcomes & Findings for Measuring Signatures in the Fluid Surrounding the Spinal Cord in Patients Who Have Problems With Intrathecal Drug Delivery (NCT NCT01117090)

Last Updated: 2017-05-30

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

47 participants

Primary outcome timeframe

1 day

Results posted on

2017-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	47
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intrathecal Pump Patients n=47 Participants 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
Age, Categorical <=18 years	7 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=39 Participants
Age, Categorical >=65 years	3 Participants n=39 Participants
Age, Continuous	37.8 years STANDARD_DEVIATION 16.7 • n=39 Participants
Sex: Female, Male Female	23 Participants n=39 Participants
Sex: Female, Male Male	24 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	3 Participants n=39 Participants
Race (NIH/OMB) White	44 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Region of Enrollment United States	47 participants n=39 Participants
Infusion system spasticity treatment sub-indication Cerebral palsy	25 participants n=39 Participants
Infusion system spasticity treatment sub-indication Multiple sclerosis	8 participants n=39 Participants
Infusion system spasticity treatment sub-indication Stroke	3 participants n=39 Participants
Infusion system spasticity treatment sub-indication Brain injury	3 participants n=39 Participants
Infusion system spasticity treatment sub-indication Spinal cord injury	2 participants n=39 Participants
Infusion system spasticity treatment sub-indication Other	6 participants n=39 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Subjects With Normal Catheter Function by Physician Diagnosis n=19 Participants Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of normal catheter function from the physician	Subjects With Catheter Complications by Physician Diagnosis n=18 Participants Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of catheter complication from the physician
Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis	13 Subjects whose CSF data agree with MD Dx	16 Subjects whose CSF data agree with MD Dx

SECONDARY outcome

Timeframe: 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.

Characterize the relationship between pressure decay-to-baseline time (in seconds) and the physician's standard trouble-shooting diagnosis

Outcome measures

Outcome measures
Measure	Subjects With Normal Catheter Function by Physician Diagnosis n=19 Participants Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of normal catheter function from the physician	Subjects With Catheter Complications by Physician Diagnosis n=16 Participants Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of catheter complication from the physician
The Relationship Between Catheter Flow Resistance Check Data and Physician's Standard Trouble-shooting Diagnosis	6.4 seconds Standard Deviation 15.3	19.9 seconds Standard Deviation 18.1

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Subjects With Normal Catheter Function by Physician Diagnosis n=18 Participants Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of normal catheter function from the physician	Subjects With Catheter Complications by Physician Diagnosis n=17 Participants Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of catheter complication from the physician
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	6.6 mmHg Standard Deviation 6.7

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Subjects With Normal Catheter Function by Physician Diagnosis n=18 Participants Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of normal catheter function from the physician	Subjects With Catheter Complications by Physician Diagnosis n=16 Participants Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of catheter complication from the physician
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	4.8 mmHg Standard Deviation 5.8

Adverse Events

Intrathecal Pump Patients

Serious events: 14 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intrathecal Pump Patients n=47 participants at risk 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
Infections and infestations Implant site infection	2.1% 1/47 • Number of events 1 • 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).
Infections and infestations Infection	2.1% 1/47 • Number of events 1 • 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).
Infections and infestations Meningitis	2.1% 1/47 • Number of events 1 • 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).
Infections and infestations Septic shock	2.1% 1/47 • Number of events 1 • 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).
Nervous system disorders Muscle spasticity	4.3% 2/47 • Number of events 2 • 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).
Nervous system disorders Nervous system disorder	2.1% 1/47 • Number of events 1 • 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).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	2.1% 1/47 • Number of events 1 • 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).
General disorders Drug withdrawal syndrom	12.8% 6/47 • Number of events 7 • 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).
General disorders Implant site effusion	2.1% 1/47 • Number of events 1 • 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).
Injury, poisoning and procedural complications Drug toxicity	2.1% 1/47 • Number of events 1 • 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).
Injury, poisoning and procedural complications Lumbar puncture headache	2.1% 1/47 • Number of events 1 • 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).
Injury, poisoning and procedural complications Overdose	2.1% 1/47 • Number of events 1 • 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).
Injury, poisoning and procedural complications Underdose	2.1% 1/47 • Number of events 1 • 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).

Other adverse events

Other adverse events
Measure	Intrathecal Pump Patients n=47 participants at risk 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
General disorders Incision site complication	4.3% 2/47 • Number of events 2 • 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).
Nervous system disorders Muscle spasticity	4.3% 2/47 • Number of events 3 • 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).
General disorders Wound dehiscence	4.3% 2/47 • Number of events 2 • 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).

Additional Information

Restorative Therapies Group Clinical Trials

Medtronic Restorative Therapies Group - Targeted Drug Delivery

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60