This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Patients with an existing implanted shunt will wear the device to acquire longitudinal data.
At least one existing ventricular CSF shunt (functional or non-functional, including "virtual off" and ligated, orphaned, abandoned, tied-off, or fractured distal catheters)
Region(s) of intact skin overlying at least one unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
Available for remote and in-person follow-up during the 30-day measurement period (for subjects using the study device at home)
Subject is expected to remain in an inpatient setting for sufficient time to complete all required study device measurements (for subjects using the device in an inpatient hospital setting)
Presence of an interfering open wound or edema over any portion of the shunt
Patient-reported history of adverse skin reactions to adhesives
Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
Investigator judges that the subject is unlikely to successfully take reliable measurements at home (for subjects using the study device at home)
Single group
Thermal Anisotropy Measurement Device
DeviceThe study device is a non-invasive sensor that is placed on the study subject's skin overlying an existing implanted CSF shunt. It uses an integrated thermal actuator and temperature sensors to assess shunt flow.
Skin Temperature
Exploratory assessment of thermal skin measurements taken with the study device
Acceleration
Exploratory assessment of accelerometer measurements taken with the study device
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