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

Medtronic

Status: Completed

Conditions: Traumatic Brain Injury; Multiple Sclerosis; Cerebral Palsy; Spinal Cord Injury

Study type: Observational

Funder types: Industry

Identifiers

NCT01117090

1656

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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