Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in People With Chronic Headaches
This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during headache and non-headache periods.
• Existing ventriculoperitoneal CSF shunt
• Subject experiencing ongoing headaches including at least 15 headache days per month for the past 3 months
• Region of intact skin overlying an unambiguously identifiable palpable 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
• Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
• Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English
• Subject is at least 6 years old but not more than 80 years old