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 activities of daily living and sleep
Existing ventricular CSF shunt
(Cohort A) A history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure
(Cohort B) A shunt revision in the previous 7 days and the investigator judges that the patient will likely be discharged within 4 days of the enrollment date
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
Shunt is not palpable or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation
Presence of an interfering open wound or edema in the study device measurement region
Subject-reported history of serious adverse skin reactions to silicone-based adhesives
Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
Rhaeos, Inc.
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator