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

Study Overview
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Brief Summary
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This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Patients with an existing implanted shunt will wear the device to acquire longitudinal data.

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

Conditions
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Hydrocephalus

Intervention / Treatment
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* Device: Thermal Anisotropy Measurement Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Existing ventriculoperitoneal CSF shunt Region of intact skin overlying an unambiguously identifiable 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 (for subjects using the study device at home) Subject is expected to remain in an inpatient setting for sufficient time to complete all required study device measurements (for subjects using the device in an inpatient hospital setting) 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 Verbal assent by minors 12 years of age and older who are able to understand the study and communicate their decision Patient is at least 6 years old but not more than 80 years old Exclusion Criteria: Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt Shunt is not palpable due to depth or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evolution. Presence of an interfering open wound or edema over any portion of the shunt Patient-reported history of adverse skin reactions to adhesives Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable Investigator judges that the subject is unlikely to successfully take reliable measurements at home (for subjects using the study device at home) Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject Prior enrollment in this study Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feasibility Assessment Cohort<br>Non-invasive device data acquisition; study is not interventional | Device: Thermal Anisotropy Measurement Device<br>* The study device is a non-invasive sensor that is placed on the study subject's skin overlying an existing implanted CSF shunt. It uses an integrated thermal actuator and temperature sensors to assess shunt flow.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Temperature | Exploratory assessment of thermal skin measurements taken with the study device | up to 90 days | 
| Acceleration | Exploratory assessment of accelerometer measurements taken with the study device | up to 90 days |