Monitoring Flow in Cerebrospinal Fluid Shunts Using a Wireless Thermal Measurement Device Non-Invasive Long-Term Study for Patients With Hydrocephalus

What this Trial Is About

Researchers are evaluating a non-invasive device designed to measure flow in cerebrospinal fluid CSF shunts in patients who already have an implanted shunt. The study focuses on hydrocephalus and aims to collect longitudinal data on shunt function using this new wireless thermal anisotropy measurement device. The study is interventional in nature but does not involve active treatment changes. Participants will wear the thermal anisotropy measurement device, which is placed on the skin over the implanted CSF shunt. This device uses a thermal actuator and temperature sensors to assess the flow through the shunt without requiring invasive procedures. The study includes a feasibility assessment cohort, and the device data acquisition is non-interventional. Participants may use the device at home or in an inpatient setting, with remote or in-person follow-up during a 30-day measurement period. During the study, researchers will monitor skin temperature and acceleration data for up to 90 days to assess device performance. Participants will be asked to communicate and document shunt symptoms in English, and verbal assent is required for minors 12 years and older. The study includes safety monitoring and follow-up to ensure data reliability and participant well-being. The total duration of participation varies depending on the setting and follow-up schedule.

Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device