Measuring Flow in Cerebrospinal Fluid Shunts Using a Wireless Thermal Device for People with Hydrocephalus and Chronic Headaches

What this Trial Is About

This research aims to evaluate a wireless thermal anisotropy measurement device designed to non-invasively assess cerebrospinal fluid CSF shunt flow in people with hydrocephalus who experience chronic headaches. The study focuses on patients with existing ventriculoperitoneal VP shunts and frequent headache episodes, exploring the relationship between device measurements and headache occurrences. The study does not involve masking or placebo controls, and it is sponsored by Rhaeos, Inc. Participants will use a wearable device at home to measure CSF shunt flow across multiple sessions during periods with and without headaches. The device is designed to be applied over the shunt region where the skin is intact and the shunt is palpable. This study period lasts 30 days, during which participants will perform regular measurements remotely and attend in-person follow-ups as needed. Throughout the study, participants will record headache symptoms and device measurement data, which researchers will correlate to understand flow patterns. The main outcome is the correlation between device flow measurements and subject-reported headaches over 30 days. The study involves ongoing communication and symptom documentation in English, with safety and adherence monitored remotely and in-person during the measurement period. Participation lasts for the 30-day measurement and follow-up timeframe.

Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device