A Double-Blinded Comparison of the Accuracy of ShuntCheck, a Non-Invasive Device

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DESCRIPTION (provided by applicant): This Phase 1 SBIR will develop a non-invasive alternative to radionuclide shunt patency testing for evaluating Normal Pressure Hydrocephalus (NPH) patients with suspected shunt malfunction. Hydrocephalus is a disorder of cerebrospinal fluid dynamics that is commonly treated by placing a shunt that carries excess fluid from the brain to the abdomen. While this treatment is generally successful, shunts inevitably fail, usually by obstruction. The clinical signs of shunt obstruction, the gradual decline into dementia-like symptoms, make shunt failure challenging to diagnose. Suspected obstruction in NPH patients is typically investigated using an invasive radionuclide shunt patency study. There are currently no non-invasive, non- radiological techniques for the early diagnosis of shunt obstruction. NeuroDx Development (NeuroDx) is developing a tool, ShuntCheck, for rapid, non-invasive measurement of CSF flow through a VP shunt by transcutaneous temperature detection as cooled CSF moves through the shunt tubing. The resulting hand-held device is a convenient method for rapidly determining shunt function. Key to translating this device into the NPH clinic is the completion of a clinical validation study to compare the device's diagnostic sensitivity and specificity to radionuclide testing. The goal of this Phase 1 project is to complete a 25 patient clinical study of ShuntCheck compared to radionuclide. In Phase 2, we anticipate conducting a multi-center outcomes study of ShuntCheck as a shunt patency test for NPH patients. This study will be conducted as a pivotal trial and will be used to support expanded labeling for ShuntCheck. The result of this study could be an important change in the diagnostic algorithm currently used to manage symptomatic NPH patients. Given the need for a non-invasive method to accurately diagnose shunt failure, the potential savings over alternative methods and the potential for improved patient outcomes, the data from this study will support a product which is commercially viable and extremely important. PUBLIC HEALTH RELEVANCE: This proposal addresses the need for diagnostic tools for use in a hospital or outpatient setting that work in real-time to quantitatively determine shunt function by supporting a clinical study comparing the accuracy of a non-invasive device, ShuntCheck, to the current invasive gold standard, radionuclide testing, in diagnosing shunt malfunction in adult normal pressure hydrocephalus (NPH) patients. The results of this study could support an important change in the standard diagnostic pathway currently used to manage symptomatic NPH patients.