Tracking Cerebrospinal Fluid Shunt Flow in Children and Teens Using a Wireless Thermal Device During Daily Activities and Sleep

What this Trial Is About

Researchers are evaluating a wireless thermal anisotropy measurement device designed to non-invasively assess cerebrospinal fluid CSF shunt flow in pediatric hydrocephalus patients. The study focuses on multiple measurements taken during daily activities and sleep to track fluid dynamics in CSF shunts. This device feasibility study aims to understand how well the device performs and monitors shunt function over time. Participants include pediatric hydrocephalus patients with existing ventricular CSF shunts divided into two groups those with stable ventricular size and no recent shunt revision in the past two years, and those who had a shunt revision within the last seven days and are expected to be discharged within four days. All participants will use the wireless wearable thermal anisotropy measurement device at home to record shunt flow data during their normal activities and sleep. Throughout the study, participants will wear the device for monitoring over 30-day periods. Researchers will assess adverse device effects, skin reactions, device usability, and data completeness. The study involves careful tracking of device safety and performance while participants continue their routine daily lives. The total study duration extends until June 2027, with primary outcome data collected over 30 days per wear period.

Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device