Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in People With Chronic Headaches
Rhaeos, Inc.
Summary
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.
Eligibility
- Age range
- 6–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Existing ventriculoperitoneal CSF shunt 2. Subject experiencing ongoing headaches including at least 15 headache days per month for the past 3 months 3. 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 4. Available for remote and in-person follow-up during the 30-day measurement period 5. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local st…
Interventions
- Devicewireless thermal anisotropy measurement device
Wireless wearable thermal anisotropy measurement device designed for use at home
Location
- Rhaeos, IncChicago, Illinois