Study to Evaluate ShuntCheck Accuracy Versus Radionuclide Test for Detecting Shunt Flow Problems in Normal Pressure Hydrocephalus Patients Aged 40 and Older

What this Trial Is About

Researchers are evaluating the diagnostic accuracy of a device called ShuntCheck compared to radionuclide shunt patency testing in patients with Normal Pressure Hydrocephalus NPH who are suspected of having a shunt obstruction. The study aims to determine how well ShuntCheck detects cerebrospinal fluid CSF shunt flow issues in this patient group. Participants will undergo the ShuntCheck diagnostic test, which is an FDA-cleared device that uses transcutaneous thermal convection to analyze shunt flow. This test is non-invasive and designed to assess whether the shunt is functioning properly without the need for radionuclide imaging. During the study, researchers will measure the sensitivity and negative predictive value of ShuntCheck compared to the radionuclide shunt patency study, with assessments at 15 minutes and 60 minutes respectively. Participants must be adults aged 40 or older with a ventriculoperitoneal VP shunt for NPH and suspected obstruction. The study involves informed consent, and safety exclusions are in place to ensure that the test does not interfere with urgent medical care or existing wounds.

Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus